Efficacy of ACL Injury Prevention Programs in Male and Female Athletes

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1 Efficacy of ACL Injury Prevention Programs in Male and Female Athletes By: Lainey Estes Doctoral Candidate University of New Mexico School of Medicine Division of Physical Therapy Class of 2016 Advisors: Marybeth Barkocy, PT, DPT & Tiffany Enache, PT, DPT Approved by the Division of Physical Therapy, School of Medicine, University of New Mexico in partial fulfillment of the requirements for the degree of Doctor of Physical Therapy. 1

2 ABSTRACT Background & Purpose: The incidence of Anterior Cruciate Ligament (ACL) injuries has increased over the past several years among athletes which has, therefore, resulted in an increase in ACL surgical reconstructions. This is a devastating injury requiring many months of intense and painful rehabilitation, an interruption in sports participation, and often results in increased risk of early onset osteoarthritis. In addition, females are at higher risk for ACL injury than males. For these reasons, ACL injury prevention programs have been a focus of sports medicine research in the past two decades. The purpose of this paper was to review the research related to this topic and more specifically answer the following question: In high school and college aged athletes, is participation in an ACL prevention program as effective for males as compared to females regarding prevention of ACL injuries? Case Description: The patient of interest was a 21-year-old male referred to outpatient orthopedic physical therapy following ACL reconstruction. The mechanism of injury was non-contact and occurred during an intramural football game approximately 3 months prior to surgery. After examination and evaluation, impairments including decreased range of motion, strength, quadriceps tone, and abnormal gait pattern were found. In addition, he demonstrated functional limitations and participation restrictions such as difficulty dressing the involved lower extremity and inability to drive, walk between classes on his college campus, and play recreational sports. Outcomes: He was discharged after six physical therapy visits over the course of five months. The location of his home and school prevented him from attending more sessions; therefore, compliance with the home exercise program was crucial to his recovery. He met all of his goals by achieving increased range of motion and strength. Additionally, his gait pattern was restored to normal. He had no difficulty with dressing, driving, or walking around campus and he was able to return to recreational sports participation. Discussion: After review of the literature, injury prevention programs were effective for reducing the rate of injury in most cases, particularly in female athlete populations. The evidence regarding the efficacy of prevention programs in male athletes was somewhat controversial with some studies reporting reduced injury rates and some reporting no effect found. The components used in injury prevention warm-up programs seemed to be similar between males and females with strengthening, plyometrics, balance, and proprioception exercises used frequently. More research would be beneficial to determine the most advantageous elements to include in injury prevention programs for male athletes. 2

3 Table of Contents Abstract... 2 Background & Purpose... 4 Case Description... 6 Reason for Referral & Patient History... 7 Examination Evaluation Interventions & Plan Outcomes Methodologies Literature Search Flow Chart Study Summaries Table Study Summaries Discussion Conclusion & Bottom Line References Appendix Analyses of Articles

4 BACKGROUND & PURPOSE The anterior cruciate ligament (ACL) is an important stabilizer of the knee joint with a primary function of controlling anterior translation of the tibia; it also functions to control rotational, varus, and valgus stresses at the knee. 1 In high school sports, knee injuries are among the most common serious injuries, accounting for 60% of sport-related surgeries. 2 ACL injuries account for 50% or more of all knee injuries sustained by athletes. 3 A figure from 1991 revealed the incidence of ACL injuries had been estimated to be around 200,000 per year in the United States. 4 Recent evidence examining ACL injury rates for multiple sports among high school athletes in the United States demonstrated an injury rate of 6.5 per 100,000 athlete exposures (AEs), defined in this study as one athlete participating in one practice or competition. 5 In addition, the ACL injury rate was higher during competition than practice. 5 Across sports, girls soccer had the highest ACL injury rate, followed by boys football. Females had a higher ACL injury rate than males in gender-comparable sports. 5 Additionally, 76.6% of ACL injuries in high school athletes resulted in surgery and the most common mechanisms of injury were player-to-player contact (42.8%) and no contact (37.9%). 5 Finally, an ACL injury can be devastating to an athlete due to the likely need for surgical reconstruction, the long and difficult rehabilitation process, the high economic cost, and increased likelihood of early osteoarthritis. 3, 6, 7, and 8 Statistics from the National Federation of State High School Associations reveal that the number of athletes participating in high school sports has nearly doubled in just over 40 years, from about 3.9 million total participants in to approximately 7.8 million total participants in This increase in sports participation has in turn led to an increase in injuries including ACL injuries, therefore, prevention strategies have been studied extensively over the last two decades. In order to develop prevention programs, attempts have been made to identify risk factors associated with ACL injuries. Risk factors can be classified into two categories: intrinsic/extrinsic and modifiable/non-modifiable. 10 Intrinsic, modifiable 4

5 factors include body mass index, neuromuscular and biomechanical deficits, hormonal status, and fatigue. Extrinsic, modifiable factors include footwear, playing surface, weather condition, level of competition, and type of sport. Intrinsic, non-modifiable factors include gender, femoral notch size, ACL volume, posterior tibial slope, ligamentous laxity, extremity alignment, previous ACL injury, and genetic predisposition. 10 It has been well established that young females are at increased risk for sustaining ACL injuries when compared to young males. Some reasons for this may be hormonal factors (estrogen and progesterone), narrow intercondylar notch, increased knee valgus and internal rotation of the hip. 10 With regards to genetic factors, individuals who sustained an ACL tear were twice as likely to have a relative with an ACL tear. 11 Furthermore, specific genes associated with collagen and matrix metalloproteinase have been associated with increased ACL rupture risk. 12, 13 Prevention efforts have focused on the modifiable risk factors for ACL injuries and much more research has been conducted with female athletes compared to males. In the literature, prevention is evaluated by assessing the number of injuries reported in each group and when decreased incidence of ACL injury is found between groups, prevention is assumed to have occurred. Many systematic reviews have been published regarding the effectiveness of ACL injury prevention programs. Paszkewicz found moderate evidence to support the use of prevention programs which focus on neuromuscular control through strengthening, plyometrics, and proprioception exercises. 14 Sadoghi concluded that there is strong evidence to support the use of ACL injury prevention programs with a substantial benefit effect found: risk reduction of 52% in females and 85% in males. 15 Stojanovic found moderate evidence to support the use of prevention programs with components of stretching, proprioception, strength, agility, and proper landing technique to reduce the rate of ACL injuries in female athletes, but a conclusion could not be reached regarding male athletes due to scarcity of the data. 16 Taylor determined that prevention programs were successful in reducing the rate of ACL injuries but the components which were most beneficial remained unclear. 17 The majority of findings suggest that injury prevention programs are effective for decreasing ACL 5

6 injury rates, however, the evidence does not provide a clear consensus about specific elements to include in warm-up programs and the literature regarding prevention programs for males is scarce. Due to increased risk for ACL injuries among female athletes as well as different neuromuscular and biomechanical considerations between genders, the following question was investigated throughout this paper: In high school and college aged athletes, is participation in an ACL prevention program as effective for males as compared to females regarding prevention of ACL injuries? CASE DESCRIPTION The patient of interest was a 21-year-old male who sustained a ruptured right ACL three months prior to undergoing reconstructive surgery. He was referred to outpatient physical therapy and had his first visit one day after surgery; his chief complaints were knee pain, stiffness, and swelling. During examination and evaluation, the patient demonstrated decreased knee range of motion, decreased lower extremity strength, atrophy of the quadriceps muscle, abnormal gait pattern, and functional limitations including difficulty with dressing the lower extremities and inability to drive. His goals for therapy were to regain range of motion, strength, and a normal gait pattern. 6

7 Date of Initial Evaluation: May 2015 Location: West Texas REASON FOR REFERRAL: The patient was a 21-year-old male college student referred to outpatient physical therapy for evaluation and treatment status post right ACL reconstruction one day prior; the surgery was performed in a city located in the Texas Panhandle. PATIENT/CLIENT HISTORY General Demographics This patient was a 21-year-old Caucasian male college student who was about 5 feet, 10 inches tall, weighed approximately 175 lbs, spoke English, and was from rural Eastern New Mexico History of Current Condition The patient s chief complaint was knee pain and stiffness. The patient reported that the ACL injury occurred while playing an intramural football game in February He stated that he planted his right foot in order to cut and change directions, twisted his knee, and felt immediate pain. He reported that his injury was not a result of a collision with another person or with an object. After the injury occurred, the patient stated he was unable to finish the football game and went immediately to the hospital. He reported that plain films were taken and the results were negative for fracture. The patient then visited an orthopedic surgeon who determined through physical examination and magnetic resonance imaging (MRI) that the ACL was ruptured and surgical reconstruction was recommended. The patient opted to wait until his school semester was finished before undergoing surgery; as a result, the surgery was performed several months after the date of injury. The patient reported that he had experienced difficulty walking normally since the onset of this injury and that he was unable to engage in sporting activities since that time. 7

8 The patient reported pain 5 out of 10 surrounding the knee at the time of initial evaluation. The patient arrived to the physical therapy clinic wearing a Don Joy Knee Brace with limits set at He was also using bilateral axillary crutches upon arrival. Past Medical History (PMH) The patient reported no diseases, illnesses, or health conditions but reported previous sports injuries including a right fractured clavicle approximately six years prior and a torn left rectus femoris muscle approximately four years prior. Past Surgical History (PSH) The patient denied previous surgeries other than related to his current condition. This was the patient s first physical therapy visit following surgery, which was completed one day prior, and the patient stated that he stayed in the hospital overnight. He also reported use of a continuous passive motion (CPM) while in the hospital and that the surgeon had instructed continued use of the CPM for the next two weeks for 6-8 hours per day. Medications The patient reported the following medications as prescribed by the physician following surgery: Norco (hydrocodone/acetaminophen), an analgesic with a strength of 7.5 mg / 325 mg (7.5 mg hydrocodone and 325 mg acetaminophen) and instructions to take one to two tablets every 4-6 hours for pain as needed, not to exceed 6 tablets per day; Meloxicam, an anti-inflammatory with a dosage of 15 mg, 1 tablet to be taken per day for 20 days. Diagnostic Testing Per patient report, plain films taken immediately following the injury were negative for fracture and the MRI taken about a month after his injury revealed a ruptured right ACL. Precautions/Contraindications 8

9 The patient s weight bearing status according to the surgeon was weight bearing as tolerated (WBAT) with use of bilateral axillary crutches at the time of initial evaluation. The patient and incision site were monitored closely for sign of infection or deep vein thrombosis (DVT). The patient s pain level was monitored closely due to very recent surgery. According to the surgeon s protocol, the knee brace should have been worn at all times except while performing therapy exercises. Past History of this Condition The patient reported receiving prehab exercises prior to undergoing surgery, which included quad sets 3 sets of 10 repetitions, straight leg raises 1-3 sets of 10 repetitions (with instruction to progress to holding 10 seconds x 10 each), and hamstring and calf stretches. Prior Level of Function The patient reported being completely independent with all activities for school and for his part-time job prior to this injury. Current Level of Function The patient reported that pain was the limiting factor on the day of initial evaluation and he reported needing assistance with dressing his lower extremities and inability to drive. Occupation/Employment He was a college student, which required walking across campus in order to get from class to class and required sitting for more than one hour at a time. He had a part-time desk job on campus which required sitting for long periods of time. Living Environment The patient reported living in a house with three other male roommates and a dog. He stated that he intended to stay with his parents for at least two weeks after the surgery. This would require 9

10 climbing two steps to get inside the house and staying on a pull-out couch in the living room. Due to the rural location of the patient s family and his plans to return to college out of state, the patient was only able to attend physical therapy sessions intermittently. Social/Recreational History This patient had good family support; his mother and sister joined him for his physical therapy appointment and planned to help him at home. He also reported having a good support system through friends and relatives once he returned to college. The patient stated that he enjoyed participating in intramural sports prior to sustaining this injury and he was unable to participate in these activities following the injury. He reported that he did not engage in any other type of regular physical activity other than walking around on campus. General Health Status The patient felt that he was in good health because he was young and fairly active prior to this injury. He denied tobacco, drug, and alcohol use. He was motivated to recover from this injury so that he could play sports again (either competitively or recreationally). Family History The patient reported that his father had hypertension (HTN) and his father s family had a history of HTN, brain aneurysms, as well as polycystic kidney disease. He reported that his mother s family had a history of type II diabetes and his maternal grandfather died of leukemia. The patient and family stated that the patient s mother sustained a ruptured ACL when she was 13 after falling off a horse but it was undiagnosed until she was in her forties and it was never surgically reconstructed. The patient s older sister sustained bilateral ACL ruptures with associated bilateral meniscus tears while playing high school sports and surgical reconstruction was performed on both. Patient s Goals 10

11 The patient stated that he wished to return to playing intramural sports and regain a normal walking pattern. The patient also indicated that he planned to be a teacher and a coach after graduating with his Bachelor s degree in one year and he hoped to be able to play sports with the players that he would eventually coach. EXAMINATION Systems Review Musculoskeletal: The patient demonstrated normal range of motion and strength in the left lower extremity but limitations were found in right knee range of motion and strength. Neuromuscular: The patient displayed normal gross coordinated movements but demonstrated an antalgic gait pattern. Cardiopulmonary: Vital signs were not taken. Integumentary: The incision site was covered with a dressing. The skin around the dressing was clean and dry with no sign of redness or warmth. In addition, skin texture and color appeared normal. Communication/Cognition: The patient was calm and alert. He was able to make his needs known and provided appropriate emotional and behavioral responses. Tests and Measurements Assistive Technology: The patient demonstrated appropriate and safe skills for using axillary crutches. He was taught how to correctly ascend and descend a curb using the crutches and demonstrated the ability to perform this activity safely and effectively. Balance: Balance was not formally assessed but patient used crutches for stability when standing. Circulation: The patient s dorsalis pedis pulses were strong and symmetrical bilaterally. 11

12 Gait: The patient demonstrated an antalgic gait pattern with use of axillary crutches. He ambulated with decreased step length on the right as well as decreased pace. He appeared to be putting weight through his forefoot of the right and weight bearing on the right was asymmetrical compared to the left. Mobility: The patient completed stand to sit and sit to stand transfers safely with contact guard assist and use of axillary crutches. Muscle Performance: Manual muscle testing was not performed on the right lower extremity due to very recent ligament reconstruction. Manual muscle testing on the left lower extremity was performed to provide a baseline and a goal for the involved limb. The knee flexors and knee extensors were found to be 5 out of 5 on the left side. Pain: The patient reported pain of 7 out of 10 during range of motion testing and 6 out of 10 during ambulation. Range of Motion: The patient s active range of motion for the left lower extremity was within normal limits. The patient s active range of motion for the right lower extremity revealed 56 of knee flexion and he was lacking 5 degrees of full knee extension. Sensation: Light touch on lower extremities was symmetrical and intact bilaterally. Observation: Visual inspection revealed reduced muscle mass on the right quadriceps compared to the left. EVALUATION OF CLINICAL FINDINGS Physical Therapy Diagnosis ICD-10: S Sprain of anterior cruciate ligament of right knee Physical Therapy Problem List Impairments: Right knee flexion and extension active range of motion limited 12

13 Decreased strength of right knee flexors and extensors Antalgic and abnormal gait pattern with use of axillary crutches Decreased quadriceps muscle tone on right Activity Limitations: Difficulty dressing lower extremities, especially on the right Unable to drive Participation Restrictions: Unable to walk quickly from class to class on campus Unable to participate in recreational sports Narrative Assessment: This patient was a 21-year-old male referred to outpatient physical therapy for evaluation and treatment status post right ACL reconstruction one day prior. He presented with signs and symptoms consistent with the typical recovery from this procedure. He exhibited active range of motion limitations, strength deficits, an antalgic gait pattern with the use of axillary crutches, and decreased tone in the quadriceps muscle. This injury resulted in functional limitations including difficulty dressing his lower extremities, especially on the right, and inability to drive. In addition, he was unable to walk quickly from class to class on campus or participate in recreational sports. Patient was expected to benefit from skilled physical therapy in order to achieve full active range of motion, increase strength of his right knee, and regain a normal gait pattern without use of crutches so that he could participate fully as a student and return to activities he enjoyed. This patient had good rehab potential because he was motivated and had good social support, but the location of his home in a rural area and having to return to college out of state were possible barriers to treatment. These was addressed through patient education about the importance of following a home exercise program on his own in order to return to full functional status. 13

14 Goals Patient would demonstrate increased active range of motion in the right knee equal to that of the uninvolved extremity in six weeks in order to help restore normal walking pattern. Patient would demonstrate increased strength of right lower extremity by achieving at least 4 out of 5 on manual muscle testing for knee flexors and knee extensors in six weeks in order to help patient regain functional and athletic strength. Patient would demonstrate a normal gait pattern without use of assistive device through equal stance time on lower extremities, equal weight distribution through lower extremities (as measured by a scale), and increased walking pace of at least 3.3 mph over a 100 yard distance in six weeks in order to help him prepare for walking around his college campus. Patient would demonstrate compliance and independence with a home exercise program containing the ACL protocol Phases I-V through patient s ability to correctly perform each exercise for the therapist using appropriate technique and form without verbal or tactile cues in four months in order to help patient ultimately return to playing recreational sports. INTERVENTIONS & PLAN Coordination and Communication Communication with the surgeon was important in order to make sure the specific rehabilitation protocol was followed. Patient-Related Instruction At initial evaluation, the patient was given exercises to perform in the clinic and a hard copy with instructions of those same exercises to be completed as a home exercise program. Those exercises were quadriceps sets (3 sets of 10 reps), straight leg raises (1-3 sets of 10 reps), double knee bends (3 sets of 10 reps), straight leg hang (5 minutes), passive knee extension (10 reps x 10 14

15 seconds), and heel slides (3 sets of 10 reps). The patient was instructed to complete this home exercise program twice a day until returning for the next visit in 10 days. The patient was reminded of the surgeon s instructions to wear his knee brace at all times for the next three weeks (including while sleeping) except when performing therapy exercises. The patient was also reminded of the surgeon s instructions to use the continuous passive motion 6-8 hours a day until visiting the surgeon again (10 days later) and to continue use of cryotherapy according to the surgeon s protocol (40 minutes on, 20 minutes off except at night). The patient was educated about signs and symptoms of infection and deep vein thrombosis and to monitor those closely. Direct/Procedural Interventions Therapeutic Exercise for gaining range of motion and strength of the right lower extremity (specifically the knee). Exercises for range of motion and strength would be progressed at each visit following the initial evaluation. Cardiovascular exercise would be introduced during the third physical therapy visit in order to help this athlete regain his endurance. Manual Therapy to reduce stiffness and improve range of motion. Patellar glides and scar massage would be introduced at the session following the initial evaluation (after removal of sutures occurred) to help prevent formation of scar tissue. Frequency/Duration of Treatment Due to patient s location, he would be seen at least six times over five months, coordinating physical therapy visits with follow-up appointments with the surgeon. 15

16 OUTCOMES This patient was discharged from physical therapy in November 2015 after six visits over the course of five months. Interventions included therapeutic exercise for range of motion, strength, and cardiovascular endurance as well as manual therapy to decrease stiffness and prevent excessive scar tissue formation. He was progressed according to the plan and had no adverse events throughout the rehabilitation process. He met all of his goals as his active range of motion of the right knee was equal to that of the left; he also demonstrated a 4+ out of 5 for manual muscle testing of both the knee flexors and knee extensors on the right; his gait pattern was restored to normal as he did not walk with a limp and evenly distributed his weight between his lower extremities. He was compliant and independent with the home exercise program as he was always able to correctly perform each exercise that he was given. Based on this patient s progress, he would be able to return to playing recreational sports and would easily be able to walk from class to class on his college campus. However, he was not followed for physical therapy long enough to practice reintegration into sports. The patient was instructed to continue with his home exercise program following discharge in order to maintain the gains made. 16

17 METHODOLOGIES In an effort to answer the PICO question presented in this paper, three databases were searched to find relevant articles. The databases utilized were PubMed, CINAHL, and PEDro. The search terms and keywords used to identify pertinent studies included: ACL injury prevention, lower limb injury, prevent, exercise, male, and female. Filters were used in the PubMed search due to the high volume of results using these search terms; the filters were: full text, humans, last 10 years, and English language. The initial search from the three databases revealed 786 results, which were then narrowed down to 73 based on appropriateness and relevance of title. Abstracts were reviewed and studies were selected based on quality, relevance to the PICO question, study design, and number of subjects. Ultimately, eight high quality studies were selected for analysis with four pertaining to female and four pertaining to male injury prevention programs. Of the studies selected, six were randomized controlled trials (RCTs) and two were systematic reviews (one with meta-analysis). The evidence regarding ACL injuries and females was much more abundant than the evidence regarding males. The systematic review selected relating to females was a synthesis of the evidence up to 2007 and the RCTs selected related to females were all completed after The literature relating to ACL injury prevention for males was scarce; therefore, one of the RCTs selected included both males and females in the sample population and another RCT did not specifically report ACL injury rates, only knee injury rates. In addition, the systematic review regarding males synthesized the evidence about the effectiveness of prevention programs for reduction of ACL injury rates and modification of ACL injury risk factors. The Literature Search Flow Chart on the next page provides a diagram detailing the literature search and selection process. This is followed by the Study Summaries Table which presents brief information at a glance for all articles selected and analyzed. Subsequently, the eight articles selected and analyzed are summarized individually in more detail. 17

18 Literature Search Flow Chart 344 MeSH Database One keyword combination & 4 filters 420 Keyword Search Three different keyword combinations & 0 filters Total Articles (Relevant to Topic) Keyword Search One keyword combination & 0 filters Some keywords: ACL Injury Prevention, Lower Limb Injury, Prevent, Exercise, Male, and Female Filters: Full Text, Humans, English, and 10 years Selected based on appropriateness & relevance of title in relation to PICO question 29 Excluded: Non-related or nonrelevant abstracts, low level of evidence 36 Excluded: Low numbers, poor study design, study s purpose not closely related to PICO question Females 4 (1 SR & 3 RCTs) Males 4 (1 SR & 3 RCTs) 8 Total Studies -Reviewed -Analyzed -Compared to PICO 18

19 Study Summaries Table Author Oxford, PEDro Purpose Gilchrist, J., et al 18 1b, 4/10 Determine the effectiveness of the Prevent Injury and Enhance Performance (PEP) Program at reducing ACL injuries, specifically non-contact ACL injuries, in National Collegiate Athletic Association (NCAA) Division I female soccer athletes. Labella, C., et 1b, 6/10 Determine the al 19 effectiveness of a coach-led neuromuscular warm-up on reducing lower extremity injuries in high school female athletes participating in basketball and soccer. Waldén, M., 1b, 7/10 Evaluate the et al 20 effectiveness of neuromuscular training in reducing the rate of acute knee injury (including ACL injury) in adolescent female soccer players. Outcome Measures Injury rates per 1000 athlete exposures (AEs) and type of injury (contact or noncontact) Injury rates per 1000 AEs and type of injury (contact or non-contact) Rate of ACL injury, rates of severe knee injury (> 4 weeks) and any acute knee injury Results ACL injury rate among intervention athletes was 1.7 times less than in control athletes (0.199 vs ; P=.198) and non-contact ACL injury rate among intervention athletes was 3.3 times less than in control athletes (0.057 vs ; P=0.66; which was a 70% decrease). Incidence of the lower extremity injuries recorded were less in every category in the intervention group than in the control group. Significant incidence rate ratios were found, specifically for non-contact ACL injuries (0.20; 95% CI, ). NNT to prevent 1 noncontact ACL injury was 191. A 64% reduction in the rate of ACL injury was found in the intervention group (rate ratio 0.36, 95% CI ). The absolute rate difference was (95% CI, to 0.001) per 1000 playing hours in favor of the intervention group and the corresponding NNT was 14, but this was not significant. Answer PICO Question? Yes Yes Yes 19

20 Yoo, J., et al 21 1a Evaluate the effectiveness of neuromuscular training programs used to prevent ACL injuries in female athletes using meta-analysis and to identify the essential components of the prevention programs. Olsen, O., et al 22 1b, 6/10 Investigate the effectiveness of a structured warm-up program designed to prevent acute injuries of the lower limb in young people (males and females) playing sports, specifically handball. Silvers- Granelli, H., et al 23 1b, 6/10 Investigate the effectiveness of the FIFA 11+ warm-up program for injury prevention and time loss due to injury in collegiate NCAA male soccer athletes. Meta-analysis was conducted to determine the incidence of ACL injury in the trained and untrained groups. Subgroup analyses were conducted according to age group, type of sport, training time (preseason, in-season, or both), and biomechanical components of programs. Rate of acute injuries to the knee or ankle per 1000 player hours. Injury rates per 1000 per AEs, total days missed due to injury, and injuries by location. The incidence of ACL injuries was found to be 34 of 3,999 in the trained group and 123 of 6,462 in the untrained group with an OR of 0.40 (95% CI, ) in the fixed model. Subgroup analysis revealed that an age under 18, soccer rather than handball, pre- and in-season training rather than either alone, and plyometrics and strengthening components rather than balance were all significant. Significantly fewer injuries occurred in the intervention group compared to the control group for injuries overall, lower limb injuries, acute knee or ankle injuries, acute knee injuries, and upper limb injuries. An 80% reduction in ruptures of knee ligaments (ACL, PCL, and MCL) was found in the intervention group, which was statistically significant. An incidence rate (IR) of injuries per 1000 AEs was found in the control group and an IR of 8.09 injuries per 1000 AEs was found in the intervention group. Sixteen ACL injuries were reported in the control group and 3 ACL injuries were reported in the intervention group accounting for a 4.25-fold reduction in the likelihood of incurring an ACL injury (rate ratio, [95% CI, ]; NNT = 70; P < 0.001). Yes Yes Yes 20

21 Van Beijsterveldt, A., et al 24 1b, 5/10 Investigate the effectiveness of The11, a warm-up program designed for injury prevention, in adult male amateur soccer players. Injury incidences per 1000 sports hours, injury severity, and location of injuries. The overall incidence of injury was almost equal between groups with 9.6 injuries per 1000 sports hours (95% CI, ) in the intervention group and 9.7 injuries per 1000 sports hours (95% CI, ) in the control group. Players in the intervention group sustained significantly fewer knee injuries than the players in the control group. ACL injury incidence was not specifically reported on. Yes Alentorn-Geli, E., et al 25 1a To synthesize the evidence regarding the effectiveness of ACL injury prevention programs for reduction of ACL injury rates or modification of risk factors for ACL injuries in male athletes. Information was systematically extracted and included intervention and study design, characteristics of participants, sport and level of competition, characteristics of prevention programs, results, and conclusions. The effectiveness of prevention programs to reduce ACL injuries in male athletes is equivocal (1 in favor, 1 against). The effectiveness of prevention programs to modify risk factors for ACL injuries in male athletes is controversial (2 in favor, 3 against) and outcome data is limited to cutting maneuvers. Yes CI, confidence interval; NNT, number needed to treat; OR, odds ratio; PCL, posterior cruciate ligament, MCL, medial collateral ligament 21

22 Gilchrist, J., Mandelbaum, B., Melancon, H., Ryan, G., Silvers, H., Griffin, L., Watanabe, D., Dick, R., & Dvorak, J. (2008). A randomized controlled trial to prevent non-contact anterior cruciate ligament injury in female collegiate soccer players. American Journal Of Sports Medicine, 36(8), p. Level of Evidence: 1b Purpose: The purpose of this study was to determine the effectiveness of an alternative warm-up in reducing ACL injuries, specifically non-contact ACL injuries, in NCAA Division I female soccer athletes. The warm-up used in this study was called the Prevent injury and Enhance Performance (PEP) Program which consisted of warm-up, stretching, strengthening, plyometric, and sport-specific agility exercises and aimed to specifically address risk factors identified for increased risk of ACL injury among female athletes. Methods: Cluster randomization was used to assign teams to the intervention or control group, 61 total teams (26 intervention, 35 control) and 1435 athletes (583 intervention, 852 control) completed the study. Intervention teams were asked to perform the program 3 times per week during a whole season (12 weeks) and control teams were instructed to perform their customary warm-up. All teams reported incidence of knee injury, including ACL injury and whether the injury was contact or non-contact; all teams also reported athletes participation in games and practice. Injury rates were calculated based on athlete exposures (AEs) and were expressed as rate per 1000 AEs. Results: All categories analyzed revealed reduced incidence of ACL injury in the intervention group compared to the control group. The rate of ACL injury during practice was significantly less in the intervention group compared to the control group (0.000 vs ; P=0.14), the rate of non-contact ACL injuries in those with a history of past ACL injury was significantly decreased in the intervention group compared to the control group (0.000 vs ; P=0.46), and the rate of ACL injuries late in the season were significantly less in the intervention group compared to the control group (0.000 vs ; P=0.25). Overall ACL injury rate among intervention athletes was 1.7 times less than in control athletes (0.199 vs ; P=.198) and non-contact ACL injury rate among intervention athletes was 3.3 times less than in control athletes (0.057 vs ; P=0.66; which was a 70% decrease). Critique/Bottom Line: This specific warm-up aimed to improve neuromuscular and proprioceptive control in young female athletes demonstrated promising results for preventing ACL injuries. ACL injury rates were less in the intervention group than the control group in every category analyzed. However, only three categories (mentioned above) reached statistical significance. This study had limitations including lack of blinding in all aspects as well as the lack of intention-to-treat analysis. This program seems feasible to incorporate into team sports practices as it requires no additional equipment and no specialized training, but it does require about 30 minutes to complete and the investigators suggested it be completed 3 times per week. Overall, the PEP program appeared to reduce the risk of ACL injuries in collegiate female soccer players, especially those with a history of previous ACL injury. 22

23 Labella, C., Huxford, M., Grissom, J., Kim, K., Peng, J., & Christoffel, K. (2011). Effect of Neuromuscular Warm-up on Injuries in Female Soccer and Basketball Athletes in Urban Public High Schools: Cluster Randomized Controlled Trial. Archives Of Pediatrics & Adolescent Medicine, 165(11), p. Level of Evidence: 1b Purpose: The purpose of this study was to determine the effectiveness of a coach-led neuromuscular warm-up on reducing lower extremity injuries in high school female athletes participating in basketball and soccer. This trial was based in Chicago which provided a mixed-ethnicity, predominantly low-income, and urban population. The neuromuscular warm-up program used in this study was called Knee Injury Prevention Program (KIPP) which combined progressive strengthening, plyometric, balance, and agility exercises; in addition, athletes were educated about avoiding dynamic knee valgus and to land with flexed hips and knees. Methods: Cluster randomization with stratification was used to assign teams to the intervention or control group; a total of 106 teams (53 intervention, 53 control) and 1492 athletes (737 intervention, 755 control) completed the study. Intervention teams were asked to incorporate the warm-up into practice sessions and the control group was instructed to perform their usual warm-up. Data was collected during one whole season (average of about 13 weeks) and included AEs and incidence of injury which were recorded by coaches and collected weekly by research assistants (RAs); RAs also interviewed athletes to obtain specific characteristics of injuries. Injury rates were calculated based on AEs and were expressed as rate per 1000 AEs. Results: Incidence of the lower extremity injuries recorded were less in every category in the intervention group than in the control group. Athletes in the intervention group had lower rates per 1000 AEs of gradualonset lower extremity injuries (0.43 vs. 1.22; P<0.01), acute-onset non-contact lower extremity injuries (0.71 vs. 1.61; P<0.01) non-contact ankle sprains (0.25 vs 0.74; P=0.01), and lower extremity injuries treated surgically [these were all ACL injuries, all occurred in the control group] (0 vs. 0.17; P=0.04). Regression analysis showed significant incidence rate ratios, specifically for non-contact ACL injuries (0.20; 95% CI, ). It was found that the number needed to treat to prevent one non-contact ACL injury was 191 and to prevent one non-contact lower extremity injury resulting in surgery, 189 athletes would need to be trained. Critique/Bottom Line: This neuromuscular warm-up demonstrated promising results for preventing lower extremity injuries in high school female athletes. All injury rates were reduced among the intervention group when compared to the control group and many of these reached statistical significance. This study had limitations including lack of blinding and the very specific population which was investigated. It seems to be a feasible program to incorporate during team sports practices or before games; it does not require additional equipment, minimal training is necessary, and it takes about 20 minutes for a team to complete. Overall, this warm-up reduced non-contact lower extremity injuries, including ACL injuries in high school female basketball and soccer athletes, however, the number needed to treat in order prevent one ACL injury or one lower extremity injury resulting in surgery was quite high (191 and 189, respectively). 23

24 Waldén, M., Atroshi, I., Magnusson, H., Wagner, P., & Hägglund, M. (2012). Prevention of acute knee injuries in adolescent female football players: cluster randomised controlled trial. BMJ: British Medical Journal (Clinical Research Edition), 2012;344:e3042. doi: /bmj.e3042 Level of Evidence: 1b Purpose: The purpose of this study was to evaluate the effectiveness of neuromuscular training in reducing the rate of acute knee injury (including ACL injury) in adolescent female soccer players. The neuromuscular warm-up program used in this study targeted core stability, balance, and proper knee alignment; it included six basic exercises that each had four levels of progression. The six exercises were: single legged squat, a pelvic lift, a two legged squat, the bench, the lunge, and jump/landing technique. Methods: Cluster randomization with stratification was used to assign soccer clubs to the intervention or control group; a total of 230 clubs (121 intervention, 109 control) and 4564 athletes ages (2479 intervention, 2085 control) completed the study. Intervention teams were asked to incorporate this specific neuromuscular warm-up twice a week during practice and the control group was instructed to train and play as usual throughout the season without any changes. Data was collected over the course of one soccer season through coaches recording individual playing time and absences for each training session and match on a computer based player s attendance form. Physical therapists were assigned to each team to serve as medical support and assist with data collection about injuries. Results: During 278,298 hours of soccer, 96 knee injuries were recorded (49 intervention, 47 control) and 21 ACL injuries were recorded (7 intervention, 14 control). Using Cox regression analysis with intention to treat, a 64% reduction in the rate of ACL injury was found in the intervention group (rate ratio 0.36, 95% CI, ). The absolute rate difference was (95% CI, to 0.001) per 1000 playing hours in favor of the intervention group and the corresponding number needed to treat was 14, but this was not significant. No significant differences were found in the secondary outcome measures (rates of severe knee injuries and any acute knee injuries). Critique/Bottom Line: This neuromuscular warm-up demonstrated promising results for preventing ACL injuries in young female soccer athletes. A significant 64% reduction in the rate of ACL injuries was found in the intervention group, however, the absolute rate difference did not reach statistical significance, but this could be due to the small number of ACL injuries. This study had limitations including lack of blinding for subjects and therapists and insufficient follow-up, but it was a very large sample size, the assessors were blinded, and an intention to treat analysis was performed. It seems to be a feasible program to incorporate into soccer team practices as it requires minimal training for coaches and only 15 minutes twice a week to complete, however, the progression of exercises may be difficult for coaches to keep up with. Overall, this warm-up program contributed to a significant reduction in the rate of ACL injuries in the intervention group compared with the control group and the number needed to treat was found to be 14, but this was not significant so this number should be interpreted with caution. 24

25 Yoo, J., Lim, B., Ha, M., Lee, S., Oh, S., Lee, Y., & Kim, J. (2010). A meta-analysis of the effect of neuromuscular training on the prevention of the anterior cruciate ligament injury in female athletes. Knee Surgery, Sports Traumatology, Arthroscopy, 18(6), p. doi: /s Level of Evidence: 1a Purpose: The purpose of this review was to evaluate the effectiveness of neuromuscular training programs used to prevent ACL injuries in female athletes using meta-analysis and to identify the essential components of the prevention programs. The studies included in this review used plyometrics, strengthening, balance exercises, and agility in different combinations for their prevention programs. Methods: The search for relevant articles included a computerized Medline search, the Cochrane Database for Systematic Reviews, manual searches of the Journals published in English or Korean, the proceedings of the American Academy of Orthodpaedic Surgeons, textbooks, and consultation with experts interested in ACL injury prevention. Initially, 2,215 articles were selected from the key word search including knee injury, ACL injury, gender difference, injury prevention, neuromuscular training, plyometrics, strengthening training, and balance training. From there, 2,184 studies were excluded after review of the abstracts and the full text of 31 articles were analyzed. Ultimately, 24 studies were excluded following this process and seven studies remained. Numbers of ACL injury for the trained and untrained groups were recorded. In addition, subgroup analyses were conducted and included age group, type of sport, training time (pre-season, in-season, or both), and biomechanical component. Results: Five of the seven studies included in this review supported the efficacy of neuromuscular training programs for prevention of ACL injuries while two did not. Pooling of the seven studies was conducted in the meta-analysis and the incidence of ACL injuries was found to be 34 of 3,999 in the trained group and 123 of 6,462 in the untrained group (OR 0.40; 95% CI, ) in the fixed model. This demonstrated the effectiveness of the preventive training. Subgroup analysis revealed that an age under 18, soccer rather than handball, pre- and in-season training rather than either alone, and plyometrics and strengthening components rather than balance were all significant. Critique/Bottom Line: This review demonstrated that neuromuscular warm-up programs were effective for preventing ACL injuries in female athletes. The most benefit was seen in ages under 18, in those who performed the training program both during pre-season and in-season, the athletes playing soccer rather than handball, and the programs that incorporated plyometrics and strengthening rather than balance. This review did not provide details about the assignment and attrition of each study and the criteria used for inclusion/exclusion was not clearly described. However, these type of training programs seem feasible, safe, and appropriate to implement in team sports practices and have shown promising results for ACL injury prevention. 25

26 Olsen, O., Myklebust, G., Engebretsen, L., Holme, I., & Bahr, R. (2005). Exercises to prevent lower limb injuries in youth sports: cluster randomised controlled trial. BMJ: British Medical Journal (International Edition), 330(7489), p. doi: /bmj f Level of Evidence: 1b Purpose: The purpose of this study was to investigate the effectiveness of a structured warm-up program designed to prevent acute injuries of the lower limb in young people playing sports, specifically handball. The warm-up program utilized exercises which aimed to improve awareness and control of the knees and ankles during standing, running, cutting, jumping, and landing. The program required use of additional equipment such as wobble boards and balance mats, as well as handballs. The exercises were for warmup, technique, balance, and strength. Methods: Cluster randomization with matching was used to assign handball clubs to the intervention or control group; a total of 120 clubs (61 intervention, 59 control) and 1837 players ages (958 intervention-808 females, 150 males; 879 control-778 females, 101 males) completed the study and were analyzed. Intervention teams were asked to incorporate this structured warm-up program at the beginning of each training session for 15 consecutive sessions and then once a week for the remainder of the season; the control group was asked to perform their training as usual during the season. Data were collected by coaches and study physical therapists over the course of one league season of handball and included incidence of injuries and exposure. Results: Over the course of the season, 129 acute knee or ankle injuries occurred, 81 injuries in the control group (0.9 (standard error 0.09) injuries per 1000 player hours) and 48 injuries in the intervention group (0.5 (standard error 0.11) injuries per 1000 player hours). Significantly fewer injuries occurred in the intervention group compared to the control group for injuries overall, lower limb injuries, acute knee or ankle injuries, acute knee injuries, and upper limb injuries. The number needed to treat to prevent one injury ranged from 11 to 59. An 80% reduction in ruptures of knee ligaments (ACL, PCL, and MCL) was found in the intervention group, which was statistically significant. The results were not extrapolated by gender but it was reported that no category of injury differed by sex. Critique/Bottom Line: This structured warm-up program demonstrated promising results for preventing lower limb injuries in young handball athletes. This trial had a sufficient sample size to show that acute knee or ankle injuries could be reduced by 50% with use of this prevention program. The authors suggest that the sample size of this trial was not near large enough (based on their power calculations) to detect a 50% reduction in ACL injuries, therefore, lower limb injuries was the primary focus. This study had limitations including lack of blinding for subject, therapists, and assessors as well as lack of concealed allocation, however, it was a large sample size, follow-up was considered sufficient, and an intention to treat analysis was performed. Overall, this warm-up program contributed to a significant reduction of acute knee and ankle injuries in the intervention group in young handball players (both male and female). The warm-up program seems feasible but the additional equipment required could be a barrier for implementation. 26

27 Silvers-Granelli, H., Mandelbaum, B., Adeniji, O., Insler, S., Bizzini, M., Pohlig, R., Junge, A., Snyder- Mackler, L., Dvorak, J. (2015) Efficacy of the FIFA 11+ Injury Prevention Program in the Collegiate Male Soccer Player. American Journal of Sports Medicine, 43(11), p. doi: / Level of Evidence: 1b Purpose: The purpose of this study was to investigate the effectiveness of the FIFA 11+ warm-up program for injury prevention and time loss due to injury in collegiate male soccer athletes. The warm-up program consisted of 15 exercises divided into 3 separate components: running exercises (including cutting, change of direction, decelerating, and proper landing techniques); strength, plyometric, and balance exercises (focusing on core strength, eccentric control, and proprioception); and running exercises to conclude the warm-up and prepare for athletic participation. Each exercise had three levels of difficulty so that progression occurred. Methods: Cluster randomization was used to assign soccer teams to the intervention or control group; a total of 61 teams (27 intervention, 34 control) and 1525 players ages (675 intervention, 850 control) completed the study and were analyzed. It was suggested that intervention teams utilize the FIFA 11+ warm-up program three times per week for the duration of one soccer season (about five months). Data about athlete exposures (AEs) and injuries were entered into a web-based injury surveillance system weekly by team athletic trainers (ATCs). Results: An incidence rate of injuries per 1000 AEs was found in the control group and an incidence rate of 8.09 injuries per 1000 AEs was found in the intervention group. The control group had a significantly higher number of injuries per team (mean ± standard deviation, ± 11.01) compared with the intervention group (mean ± standard deviation, ± 3.64) (P < 0.001). The number of participants needed to be exposed to the intervention to reduce one injury in the intervention group (NNT) was three. When data were stratified for type of knee injury, there were 16 ACL injuries reported in the control group and three ACL injuries reported in the intervention group accounting for a 4.25-fold reduction in the likelihood of incurring an ACL injury (rate ratio, [95% CI, ]; NNT = 70; P < 0.001). In addition, total days missed because of injury were significantly higher in the control group than in the intervention group (P = 0.007). Critique/Bottom Line: It was concluded that the FIFA 11+ significantly reduced rates of injury by 46.1% and decreased time loss due to injury by 28.6% in competitive collegiate male soccer athletes. Also, a significant reduction in the likelihood of sustaining an ACL injury was also found. In addition, an inverse relationship between injury rates and compliance was found: as compliance increased, injury rates subsequently decreased with statistical significance. This study had limitations including lack of blinding for subjects, data collectors, and assessors as well as lack of intention to treat analysis, however, it was a large sample size, allocation was concealed, and follow-up was considered sufficient. Overall, the FIFA 11+ contributed to a significant reduction in injury rates and reduced time loss to injuries in collegiate male soccer players. The warm-up seems feasible to implement because it requires no additional equipment and minimal training for coaches but the exercises could be difficult for players to learn and the progression of exercises could be challenging to keep up with. 27

28 van Beijsterveldt, A., van de Port, I., Krist, M., Schmikli, S., Stubbe, J., Frederiks, J., & Backx, F. (2012). Effectiveness of an injury prevention programme for adult male amateur soccer players: a clusterrandomised controlled trial. British Journal Of Sports Medicine, 46(16), p. doi: /bjsports Level of Evidence: 1b Purpose: The purpose of this study was to investigate the effectiveness of The11, a warm-up program designed for injury prevention, in adult male amateur soccer players. This program was developed with the support of the World Football Association FIFA and included exercises which focused on core stability, eccentric training of thigh muscles, proprioceptive training, dynamic stabilization, and plyometrics with straight leg alignment. This program was the predecessor of the FIFA 11+. Methods: Cluster randomization was utilized to assign soccer teams to the intervention or control group. A total of 23 teams (11 intervention, 12 control) with 456 players (223 intervention, 233 control) completed the study and were analyzed. Teams in the intervention group were instructed to integrate The11 in the warmup of each practice session (at least twice a week) during one entire soccer season; the teams in the control group were told to continue their practice sessions as usual. Data about individual exposure time (practice sessions and matches) were reported weekly by coaches and data about soccer injuries were reported by team paramedics or sports trainers into a specific web-based injury system. Results: Over the course of the season (which was 33 weeks), 427 injuries were recorded affecting 274 of the 456 players (60.1%). The overall incidence of injury was almost equal between groups with 9.6 injuries per 1000 sports hours (95% CI, ) in the intervention group and 9.7 injuries per 1000 sports hours (95% CI, ) in the control group. No significant differences were found for injury severity either, and the only significant finding was the location of injuries, in which players in the intervention group sustained significantly fewer knee injuries than the players in the control group. ACL injury incidence was not specifically reported on. Critique/Bottom Line: This warm-up program did not demonstrate effectiveness for injury prevention (in regards to injury incidence or injury severity) in adult amateur male soccer players. It was reported that this particular program has been tested in at least two other populations, in which it significantly reduced injury rates in male Swiss junior soccer players but did not demonstrate effectiveness among female Norwegian junior soccer players. This study has limitations including lack of blinding among subjects, therapists, and assessors as well as the omission of an intention to treat analysis, however, it had a decent sample size and sufficient follow-up. Overall, this program seems feasible to implement in soccer team practices but some of the exercises could be difficult to learn. In addition, its lack of effectiveness in this population suggests that more research should be completed focusing on injury etiology and risk factors in adult male amateur soccer players. 28

29 Alentorn-Geli, E., Mendiguchía, J., Samuelsson, K., Musahl, V., Karlsson, J., Cugat, R., & Myer, G. D. (2014). Prevention of non-contact anterior cruciate ligament injuries in sports. Part II: systematic review of the effectiveness of prevention programmes in male athletes. Knee Surgery, Sports Traumatology, Arthroscopy,22(1), p. doi: /s x Level of Evidence: 1a Purpose: The purpose of this review was to synthesize the evidence regarding the effectiveness of ACL injury prevention programs in male athletes. Specifically, the investigators analyzed studies which examined the effectiveness of prevention programs for ACL injury rate reduction or modification of risk factors for ACL injuries. The prevention programs used in the studies included in this review utilized exercises focusing on proprioception, balance, eccentric strength, jumping, cutting, single leg activities, trunk stabilization, and resistance. Methods: The search for relevant articles was performed through three databases: PubMed, The Cochrane Library, and EMBASE. The search/mesh terms included anterior cruciate ligament, ACL, injuries, injury, tear, tears, tearing, rupture, ruptures, sports, and athletes, with the following filters: not animals, humans, and English. The primary focus of this review was prevention programs designed to either reduce ACL injury rates or modify risk factors for ACL injuries in male athletes. The initial search produced a total of 3322 relevant articles, 30 studies were reviewed in full-text, and ultimately 7 articles were selected for inclusion. Data was extracted systematically and included intervention, study design, characteristics of participants, sport and level of competition, characteristics of prevention programs, results, and conclusions. The methodological quality of each study was assessed to determine the risk of bias. Results: Only two studies investigated the effectiveness of prevention programs for reduction of ACL injury rates in male athletes; the results were equivocal (1 in favor, 1 against) and only referred to soccer players. Of the studies that examined the effectiveness of prevention programs to modify risk factors for ACL injuries in male athletes, the results were controversial (2 in favor, 3 against) and outcome data is limited to the cutting maneuver. A proprioceptive training program was utilized in the study that demonstrated in a significant reduction of ACL injuries. The effective programs for risk factor modification included technique modification (side-step cutting maneuvers) and balance training (using balls, discs, and single leg exercises). Critique/Bottom Line: This review demonstrated that the use of prevention programs for ACL injury reduction and for modification of risk factors for ACL injuries in male athletes is neither supported nor opposed, based on the current evidence. The effectiveness of prevention programs to reduce ACL injury rates was equivocal and the effectiveness of prevention programs to modify risk factors for ACL injuries was controversial. This review provided adequate information about each individual study and even included information about the quality of each study. These type of training programs seem feasible, safe, and appropriate to implement in team sports practices, however, the results regarding the effectiveness of prevention programs has been mixed when studied in male athletes. This review demonstrates the need for more research in this area regarding the effectiveness of prevention programs as well as the risk factors for ACL injuries in male athletes. 29

30 DISCUSSION ACL injury prevention programs have been a common topic of research in the sports medicine discipline over the past two decades due to an increase in the incidence of ACL injuries and ACL reconstructive surgeries, particularly in females. 5, 26, and 27 Physical therapy plays a critical role in the rehabilitation of an athlete following ACL reconstruction; but if more of these injuries could be prevented, athletes would reap short- and long-term benefits. The goal of this paper was to examine the effectiveness of prevention programs to reduce ACL injury rates in both male and female high school and college-aged athlete populations and secondarily to examine the specific components of prevention programs used in both genders. The evidence analyzed throughout this paper regarding prevention programs in female athletes reached overwhelmingly similar conclusions. The findings suggest that injury preventive programs are effective to reduce risk of ACL injuries, particularly in young female soccer athletes. 18, 19, 20, and 21 Analysis of the studies which examined prevention programs in male athletes revealed mixed results. Olsen conducted a randomized controlled trial (RCT) which included a sample of both male and female athletes; it was concluded that a structured warm-up program was effective for reducing knee and ankle injury in young athletes. 22 Additionally, an 80% reduction in ruptures of knee ligaments (ACL, PCL, and MCL) was found. 22 Silvers-Granelli performed an RCT that found a specific prevention program (the FIFA 11+) to be effective for injury rate reduction and a 4.25 fold reduction in the likelihood of sustaining an ACL injury in collegiate male soccer players. 23 van Beijsterveldt conducted an RCT that utilized a similar program (The11, developed before the FIFA 11+) though ACL injury rates were not specifically reported on, overall injury incidences were found to be almost equal between the intervention and control groups. 24 Therefore, it was concluded that this program was not effective for injury rate reduction in adult male amateur soccer players. 24 Alentorn-Geli performed a systematic review and determined that the evidence about the 30

31 effectiveness of prevention programs to reduce ACL injuries in male athletes is equivocal and the evidence about the effectiveness of prevention programs to modify risk factors for ACL injuries in male athletes is controversial. 25 The components which make up injury prevention programs is an important aspect to consider especially because of biomechanical, neuromuscular, and other risk factor differences between males and females. Gilchrist utilized a program which was found to be effective for ACL injury risk reduction in collegiate female soccer athletes and included exercises for jogging, stretching, strengthening, plyometrics, and agilities. 18 Labella applied a warm-up that resulted in reduced non-contact lower extremity injuries, including ACL injuries, in female high school soccer and basketball players. 19 This program combined progressive strengthening, plyometric, balance, and agility exercises with emphasis to avoid dynamic knee valgus and landing with hips and knees flexed. 19 Walden used a program that demonstrated a significantly reduced ACL injury rate in adolescent female soccer players and utilized a progression of exercises focusing on knee control and core stability. 20 Yoo conducted a systematic review and meta-analysis and concluded that ACL injury preventive programs were effective in female athletes; in addition, plyometric and strengthening exercises were found to be the most valuable components of these warm-up programs rather than balance exercises. 21 Olsen found that in youth handball players (both male and female), knee and ankle injuries were reduced by 50% with utilization of a program that focused on improvement of awareness and control of the knees and ankles through exercises for warm-up, technique, balance, and strength. 22 Silvers-Granelli performed a recent study that reported significantly reduced injury rates (including ACL injuries) and decreased time loss to injury in collegiate male soccer players using the FIFA 11+ prevention program which consisted of running, strength, plyometric, and balance exercises with progression. 23 However, van Beijsterveldt found that use of the program that preceded the FIFA 11+, The11, resulted in no significant differences in overall injury incidences or injury severity in adult amateur male soccer players. 24 ACL injury rates were not specifically reported in this study but it was found that the 31

32 intervention group sustained significantly fewer knee injuries. 24 The11 warm-up program included exercises focusing on core stability, eccentric training of thigh muscles, proprioceptive training, dynamic stabilization, and plyometrics with straight leg alignment. 24 Alentorn-Geli completed a systematic review in which one study concluded that use of a prevention program was effective for ACL injury rate reduction in male athletes but one study found no effect. 25 The program used in the study which demonstrated effectiveness utilized proprioception and balance exercises. 25 Finally, a recent review article, which was not analyzed in this paper, extensively reviewed the evidence regarding biomechanical and neuromuscular characteristics of male athletes in order to make recommendations for future prevention programs. 28 It was suggested that prevention programs include exercises with multi-plane biomechanical components, including single-leg maneuvers in dynamic movements, reaction to and decision-making in unexpected situations, appropriate foot positioning, and consideration of playing surface, as well as enhancing neuromuscular aspects such as fatigue, proprioception, muscle activation, and inter-joint coordination. 28 After review of the literature, it can be concluded that prevention programs have stronger evidence to support their efficacy in female athletes, which could be a result of a higher volume of research conducted in females than males. It seems as though warm-up programs of many types and utilizing different components have been effective for females, but exercises focusing on strengthening, plyometrics, and agilities seem to be important and frequently used elements. 18, 19, 21 The results regarding the efficacy of prevention programs in male athletes have been mixed and there does not seem to be a consensus as to what components are most valuable. 22, 23, 24, 25 Balance, strength, and proprioception exercises have been included in programs demonstrating promising results, however, other studies examining programs with similar elements have found no effect. 22, 23, 24, 25 The patient of interest in this case likely could have benefited from participation in structured warmup program aimed at injury prevention. The evidence regarding the efficacy of these types of programs in male athletes has been mixed, but the programs do not seem to increase risk of injury and are typically 32

33 feasible to implement. However, it is doubtful that the patient in this case would have regularly engaged in a warm-up of this type because he was playing intramural football while attending college, rather than organized, competitive sports. In all studies identified throughout this paper, data were collected from organized, competitive sports teams. Evidence regarding use of injury prevention programs in leisure athletes was not discovered but based on the results from the studies analyzed, it can be reasonably concluded that athletes of all ages and playing a variety of sports could potentially benefit from an injury prevention warm-up. CONCLUSION & BOTTOM LINE Overall, the evidence to support the effectiveness of ACL injury prevention programs is moderate to good. Therefore, injury prevention warm-ups would be important to implement among all athlete populations, but particularly in young females. The injury prevention programs utilized in the articles analyzed throughout this paper reveal non-drastic differences between programs designed for males and programs designed for females. It seems that a variety of components have been applied to warm-ups for both genders such as strength, proprioception, balance, and plyometric exercises. More research would be beneficial to determine the most advantageous elements to include in injury prevention programs for male athletes. 33

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35 15. Sadoghi, P., von Keudell, A., & Vavken, P. (2012). Effectiveness of anterior cruciate ligament injury prevention training programs. Journal Of Bone & Joint Surgery, American Volume, 94-A(9), p. 16. Stojanovic, M. D., & Ostojic, S. M. (2012). Preventing ACL Injuries in Team-Sport Athletes: A Systematic Review of Training Interventions. Research In Sports Medicine, 20(3/4), p. doi: / Taylor, J. B., Waxman, J. P., Richter, S. J., & Shultz, S. J. (2015). Evaluation of the effectiveness of anterior cruciate ligament injury prevention programme training components: a systematic review and meta-analysis. British Journal of Sports Medicine, 49, p. doi: /bjsports Gilchrist, J., Mandelbaum, B., Melancon, H., Ryan, G., Silvers, H., Griffin, L., Watanabe, D., Dick, R., & Dvorak, J. (2008). A randomized controlled trial to prevent non-contact anterior cruciate ligament injury in female collegiate soccer players. American Journal Of Sports Medicine, 36(8), p. 19. Labella, C., Huxford, M., Grissom, J., Kim, K., Peng, J., & Christoffel, K. (2011). Effect of Neuromuscular Warm-up on Injuries in Female Soccer and Basketball Athletes in Urban Public High Schools: Cluster Randomized Controlled Trial. Archives Of Pediatrics & Adolescent Medicine, 165(11), p. 20. Waldén, M., Atroshi, I., Magnusson, H., Wagner, P., & Hägglund, M. (2012). Prevention of acute knee injuries in adolescent female football players: cluster randomised controlled trial. BMJ: British Medical Journal (Clinical Research Edition), 2012;344:e3042. doi: /bmj.e Yoo, J., Lim, B., Ha, M., Lee, S., Oh, S., Lee, Y., & Kim, J. (2010). A meta-analysis of the effect of neuromuscular training on the prevention of the anterior cruciate ligament injury in female athletes. Knee Surgery, Sports Traumatology, Arthroscopy, 18(6), p. doi: /s Olsen, O., Myklebust, G., Engebretsen, L., Holme, I., & Bahr, R. (2005). Exercises to prevent lower limb injuries in youth sports: cluster randomised controlled trial. BMJ: British Medical Journal (International Edition), 330(7489), p. doi: /bmj f 23. Silvers-Granelli, H., Mandelbaum, B., Adeniji, O., Insler, S., Bizzini, M., Pohlig, R., Junge, A., Snyder-Mackler, L., Dvorak, J. (2015) Efficacy of the FIFA 11+ Injury Prevention Program in the Collegiate Male Soccer Player. American Journal of Sports Medicine, 43(11), p. doi: / van Beijsterveldt, A., van de Port, I., Krist, M., Schmikli, S., Stubbe, J., Frederiks, J., & Backx, F. (2012). Effectiveness of an injury prevention programme for adult male amateur soccer players: a cluster-randomised controlled trial. British Journal Of Sports Medicine, 46(16), p. doi: /bjsports Alentorn-Geli, E., Mendiguchía, J., Samuelsson, K., Musahl, V., Karlsson, J., Cugat, R., & Myer, G. D. (2014). Prevention of non-contact anterior cruciate ligament injuries in sports. Part II: systematic review of the effectiveness of prevention programmes in male athletes. Knee Surgery, Sports Traumatology, Arthroscopy,22(1), p. doi: /s x 26. Mall, N. A., Chalmers, P. N., Moric, M., Tanaka, M. J., Cole, B. J., Bach, B. R., & Paletta, G. A. (2014). Incidence and Trends of Anterior Cruciate Ligament Reconstruction in the United 35

36 States. American Journal Of Sports Medicine, 42(10), p. doi: / Csintalan, R. P., Inacio, M. C., & Funahashi, T. T. (2008). Incidence rate of anterior cruciate ligament reconstructions. The Permanente Journal, 12(3): p. 28. Sugimoto, D., Alentorn-Geli, E., Mendiguchía, J., Samuelsson, K., Karlsson, J., & Myer, G. (2015). Biomechanical and Neuromuscular Characteristics of Male Athletes: Implications for the Development of Anterior Cruciate Ligament Injury Prevention Programs. Sports Medicine, 45(6), p. doi: /s

37 Appendix Intervention Evidence Appraisal Worksheet Citation: Gilchrist, J., Mandelbaum, B., Melancon, H., Ryan, G., Silvers, H., Griffin, L., Watanabe, D., Dick, R., & Dvorak, J. (2008). A randomized controlled trial to prevent non-contact anterior cruciate ligament injury in female collegiate soccer players. American Journal Of Sports Medicine, 36(8), p. Level of Evidence (Oxford scale): 1b Is the purpose and background information sufficient? Appraisal Criterion Reader s Comments Study Purpose Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Yes- The purpose is clearly stated in the form of a hypothesis in the abstract and in a statement within the introduction. In the abstract, the hypothesis is that a simple on-field alternative warm-up program can reduce non-contact ACL injuries. In the introduction, it is noted this cluster randomized controlled trial examines whether the use of the alternative warm-up to enhance neuromuscular and proprioceptive control can reduce the number of ACL injuries, specifically noncontact ACL injuries, in NCAA Division I female soccer athletes. Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study Yes- The risk factors for ACL injuries are provided with sources, specifically for females. The neuromuscular and proprioceptive warm-up program that is used in the study is briefly explained which targets neuromuscular and proprioceptive deficits contributing to increased risk for ACL injury in female athletes. The warmup program was designed for both injury prevention and performance enhancement and includes stretching, strengthening, plyometrics, and sport-specific agility exercises; it is known as the PEP program. In the introduction, the feasibility of this study was addressed and a pilot study was also referenced. 37

38 Does the research design have strong internal validity? Appraisal Criterion Reader s Comments Discuss possible threats to internal validity in the research design. Include: minimal here. Assignment Attrition History Instrumentation Maturation Testing Compensatory Equalization of treatments Compensatory rivalry Statistical Regression 38 Assignment-was random and the sample size was large so threats would be Attrition-the rate of attrition in this trial is somewhat concerning. In a flow chart, it is noted that 75 teams were randomized but that 6 never initiated reporting so 69 teams began the study (34 intervention and 35 control). Then it is stated that 8 teams started the program and reporting but dropped out within the first few weeks of the season, these were all in the intervention group and there is no explanation offered for a reason for these drop-outs. History-no external events were noted so threats here are probably minimal. Instrumentation-the investigators did not actually perform the outcome measures except for combining all the final data received. The athletic trainers for each team reported on incidence of injuries and athlete exposures. Specific definitions are provided for knee injury, ACL injury, and how an ACL injury was classified as contact or non-contact. It seems that these definitions would produce the information that the investigators were looking for but it appears that the authors created these definitions. There were observers who visited 8 teams (4 intervention and 4 control) twice over the course of the season to determine the use of the warm-up program in the intervention teams and to find out if the control teams were using similar types of exercises. The instrument used to assess this information appears to be something that the investigators also created for the use of this study. In addition, the observers did not observe every team in the study so there is a chance that other control teams were using similar exercises or that intervention teams were either not using

39 the warm-up program as often as the investigators wanted them to or the athletes could have been doing the exercises incorrectly. These could have resulted in threats to internal validity. The investigators did not actually see their interventions being put into practice but relied on the athletic trainers and coaches to implement the program, in addition, the teams in the control group were also not monitored closely by the investigators. Maturation-this study was conducted over the course of 12 weeks in young adult female athletes so the likelihood of changes occurring are minimal. Testing-pre-tests were not done and outcome measures were basically just the incidence of injury in different scenarios so testing was likely not a threat. Compensatory equalization of treatmentssince blinding of subjects and assessors was not done, this could be a threat to internal validity through the contact of the investigators to the athletic trainers in the control teams. Compensatory rivalry-again, since blinding was not done, there is a chance that players from the control group either saw or communicated with players of the intervention group which could have impacted their practice (they could have tried harder knowing they were not in the treatment group or they could have stopped trying because they knew they were not getting the good treatment ). However, since teams most likely practiced separately from other teams in the study and communication between teams is probably unlikely, it seems that the chance of compensatory rivalry occurring would have been slim. But since blinding was not done, it cannot be ruled out. Statistical regression-subjects were similar at baseline with no outliers, therefore, 39

40 statistical regression threats to internal validity were limited. Are the results of this therapeutic trial valid? Appraisal Criterion 1. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study s results? 2. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study s results? 3. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? Reader s Comments Yes- Cluster randomization was used because whole teams were investigated, there were 26 intervention teams and 35 control teams. However, the authors do not report the specific method used to perform the randomization. There are potential consequences of this type of randomization, including that the number of participants in each group was quite different (583 athletes in the intervention teams and 852 athletes in the control teams). But, this type of randomization does make sense for this type of study because when a team is performing a warm-up, it should be the same. It would be very difficult to have players on the same team performing different warm-ups. No- This was not specifically reported, but since allocation was randomized it can be assumed that the investigators did not know which teams would be assigned to either the intervention or control groups prior to allocation. Yes- In a table, the characteristics of the teams and athletes provide minimal demographic characteristics from the beginning of the study. Average number of years in college, average age, average height, average weight, and average BMI were all not significantly different between groups. In addition, number of athletes with history of knee injury and number of athletes with history of ACL rupture were not significantly different between groups. It appears that the groups were similar based on the reported characteristics. 40

41 4. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 5. Did the investigators know to which treatment group subjects were assigned? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 6. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study s results? Yes- This was also not specifically reported on so it must be assumed that the teams were not blinded as to which group they were in. Even though it would be assumed that teams from the intervention group and teams from the control group would not practice together, team members from different groups could have had communication and could have potentially seen differences in their warmups before games. Additionally, teams in the control group probably knew they were not receiving the intervention since they were asked to perform their customary warm-up. This could potentially have resulted in consequences such as the previously mentioned compensatory rivalry. Yes- Again, this is not specifically reported but it is assumed that the investigators were not blinded to the groups that the teams were assigned to. In this specific study, the investigators were not present when the intervention program was being conducted but they were in close contact with athletic trainers from each team. The investigators could have been providing the athletic trainers (ATCs) in the intervention groups more attention and more information which could have been a threat to the internal validity of the study. Yes- The teams in the intervention group were instructed to incorporate the alternative warm-up 3 times per week during the regular season. Control teams were asked to perform their customary warmup. Over the course of the season, two observers visited 8 teams (4 intervention and 4 control) twice during the season to see how the program was being implemented in the intervention group and to see if the control group teams were 41

42 7. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study s results? 8. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study s findings? 9. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? incorporating any exercises similar to the ones included in the PEP program. No- There was no follow-up time after the conclusion of that season. The study lasted for a whole season (12 weeks) of soccer and data were collected for ACL injury incidence early in the season and late in the season but no data collection beyond that point occurred. Since data was not collected after this, the lasting effects of the alternative warm-up cannot be determined and it is not known how the warm-up could have helped prevent injuries after the season ended. No- As noted previously, 75 teams were randomized initially (38 intervention, 37 control) but 6 never initiated reporting (4 intervention, 2 control) so 69 teams began the study (34 intervention, 35 control). However, 8 teams started the program and began reporting but dropped out within the first few weeks of the season (all 8 were in the intervention group). 61 teams completed the study (26 intervention, 35 control). There is no explanation as to why this attrition may have occurred. Also, it is not reported what was done about the attrition but it seems as though additional statistical analysis was performed on all intervention teams, including those previously excluded. The implications of the way the attrition was handled could be serious; the warm-up program could have been too dangerous or could have actually caused injury but that remains unknown since those teams were unaccounted for in the main statistical analysis. No- This was called an as-treated analysis but as mentioned in the above question, additional statistical analysis was performed on all intervention teams, including those previously excluded. It 42

43 b. If the data were excluded, what are the potential consequences for this study s results? Are the valid results of this RCT important? Appraisal Criterion 10. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p-values and CI c. Include effect size with p-values and CI d. Include ARR/ABI and RRR/RBI with p-values and CI e. Include NNT and CI f. Other stats should be included here appears that the main set of data reported did not include the initially excluded data from those teams which dropped out but an intention-to-treat analysis was performed and briefly reported on. It was noted that in this analysis, the ACL injury rates among intervention teams were potentially falsely increased in this intention-to-treat analysis because of poor reporting of athlete exposures [games and practice] (AEs) by excluded teams. Not including the data from the teams that dropped out results in unequal sized groups (there was many more participants in the control group). Having so many drop outs in the intervention group is suspicious because maybe the warm-up program was actually having a negative effect on the players. Reader s Comments The number of injuries were reported as raw numbers and as the rate per 1000 athlete exposures (AEs) for the intervention and the control groups, then these were compared and p values were reported. In each of the following categories, number of all knee injuries, number of ACL injuries, and number of non-contact ACL injuries were reported for: total (practice + game + other), practice, game, history of past ACL injury, no history of ACL injury, early in the season, and late in the season. The statistically significant findings included: number of ACL injuries in practice (0 in intervention group and 6 in control group) P=.014, number of noncontact ACL injuries in those with a history of past ACL injury (0 in intervention group and 4 in control group) P=.046, and number of ACL injuries late in the season (0 in intervention group and 5 in control group) P=.025. Confidence intervals were not reported. 43

44 11. What is the meaning of these statistical findings for your patient/client s case? What does this mean to your practice? 12. Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? 44 These statistics demonstrate some significantly positive findings for the PEP program to effectively prevent ACL injury in female soccer athletes. However, many of the comparisons between groups did not reach statistical significance. The MCID was not discussed, but the intervention group participants had fewer occurrences of ACL injury in every single category which seems clinically relevant. Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion Reader s Comments 13. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3 rd party coverage to provide this treatment? 14. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 15. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? This prevention warm-up program does seem appropriate to implement for young female athletes. It can be done during regular practice time without the need for additional equipment or training. It can be completed by an entire team in about 30 minutes and it is suggested to be performed 3 times per week. The average age of the athletes in this study was about 20 years old. This is very similar to the patient of interest because he was 21 years old when his injury occurred. The main difference is that this study focused specifically on Division I female soccer players whereas the patient in this case was playing intramural football at the time of the injury. This study provides a specific warm-up program designed to help prevent ACL injury in female soccer players and it can be compared to the programs that have been designed for male athletes, which is the focus of this project. Using this program definitely did not seem to increase the risk of ACL injury because the intervention group had lower incidence of ACL injury in every category that was analyzed. So it does not seem like this program would cause any harm but it was mentioned that there was one occurrence of an adverse effect. Early in the season in the intervention group, an athlete

45 16. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? 17. Are there any threats to external validity in this study? tripped while doing a lateral hop over a ball (during the warm-up) which resulted in a tibia/fibula fracture. The steps taken to ensure this did not happen again were mentioned. Aside from this one incidence, this program seems safe with little risk of injury due to performing these prescribed exercises. However, incorporating this program for 30 minutes 3 times per week may be more time than teams would want to spend on these types of exercises. It does seem that the benefits outweigh the disadvantages though. This program also does not require any special equipment to perform, which makes it more convenient for implementation. Yes because my patient would have liked to prevent this injury if possible and if he knew that performing this warm-up program would help reduce his risk of injury, he would have tried it. However, since he was not a serious, competitive athlete at the time of injury but instead was playing for fun, he may not have been interested in spending 30 minutes 3 times per week trying to reduce his risk of tearing his ACL. Yes, this study investigated the use of this prevention program in a very specific population Division I female soccer players. Therefore, it is hard to generalize these results to other sports, other age groups, and to male athletes. But, the authors mention that this same program was used in a pilot study which looked at year old female club soccer players and had similar results to this study, indicating this program s possible effectiveness across multiple age groups. What is the bottom line? Appraisal Criterion PEDRO score (see scoring at end of form) *This score has been confirmed* Reader s Comments 4/10 Eligibility criteria: Yes Random allocation: Yes Concealed allocation: No 45

46 Summarize your findings and relate this back to clinical significance Baseline comparability: Yes Blind subjects: No Blind therapists: No Blind assessors: No Adequate follow-up: No Intention-to-treat analysis: No Between group comparisons: Yes Point estimates and variability: Yes Note: Eligibility criteria item does not contribute to total score This study demonstrated that incidence of ACL injury was reduced when this specific warm-up program aimed to enhance neuromuscular and proprioceptive control was implemented. It is feasible and would be easy to incorporate into practices for team sports since it requires no additional equipment, however, it may be time consuming as it requires about 30 minutes 3 times per week. Some threats to internal and external validity were found so the findings from this study may not be generalizable to other populations. 46

47 Intervention Evidence Appraisal Worksheet Citation: Labella, C., Huxford, M., Grissom, J., Kim, K., Peng, J., & Christoffel, K. (2011). Effect of Neuromuscular Warm-up on Injuries in Female Soccer and Basketball Athletes in Urban Public High Schools: Cluster Randomized Controlled Trial. Archives Of Pediatrics & Adolescent Medicine, 165(11), p. Level of Evidence (Oxford scale): 1b Is the purpose and background information sufficient? Appraisal Criterion Reader s Comments Study Purpose Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Yes- The purpose is clearly stated in the abstract and in the introduction. In the abstract, the objective is to determine the effectiveness of coach-led neuromuscular warm-up on reducing lower extremity (LE) injuries in female athletes in a mixedethnicity, predominately low-income, urban population. In the introduction, it says the study goals were (1) determine whether urban public high school coaches can consistently implement a neuromuscular warm-up and (2) to measure its effect on non-contact LE injuries in female soccer and basketball athletes. It was also hypothesized that implementation of the program in this setting would be feasible and they expected non-contact LE injuries to be reduced in a dose-related manner. Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study Yes- The introduction addresses the fact that the number of female athletes has increased dramatically over the past few decades and it references the devastating effects that can accompany a serious athletic injury, such as an ACL rupture. In addition, the risk factors for ACL injury were discussed for female athletes and the warm-up program was briefly described. The neuromuscular training utilized in this study was described as combining progressive strengthening, balance, 47

48 Does the research design have strong internal validity? Appraisal Criterion Reader s Comments Discuss possible threats to internal validity in the research design. Include: Assignment minimized. Attrition History Instrumentation Maturation Testing Compensatory Equalization of treatments Compensatory rivalry Statistical Regression 48 plyometric, and agility exercises with education on avoiding dynamic knee valgus, a position that increases ACL injury risk, and landing jumps with flexed hips and knees, which reduces ACL strain. Finally, the need for this specific study was addressed and it was noted that no other study had used coach-led neuromuscular training in this particular population. Assignment-was random and the sample size was large so internal validity threats associated with assignment were Attrition-in a flow chart the number of coaches, teams, and athletes were provided for the intervention group and the control group. Initially, 95 coaches, 111 teams, and 1558 athletes enrolled in the study and were randomized (coaches: 48 control, 47 intervention; teams: 57 control, 54 intervention; athletes: 798 control, 760 intervention). But the authors noted that five coaches submitted no data for their single teams and one coach reported data for only one of his two teams; in addition, it was noted that these 6 teams were excluded from the analysis. So the final numbers for those that completed the study were: 90 coaches (45 control, 45 intervention), 106 teams (53 control, 53 intervention), and 1492 athletes (755 control, 737 intervention). Overall, the attrition rate was low as 94.7% of coaches completed the study, however, excluding the teams that dropped out from the data analysis could be a threat to internal validity. History-no external events were noted so threats here were minimal. Instrumentation-the investigators did not actually perform the outcome measures except for combining all the final data

49 received. The coaches for each team reported on incidence of injuries and athlete exposures (1 athlete exposure was participating in all or part of a practice or game). Research assistants collected information from the coaches weekly about the number of athlete exposures (AEs) and they interviewed injured athletes about injury date, mechanism, injured body part, injury type, type of medical evaluation, treatment, and games and practices missed due to the injury. Data retrieved from the coaches and from the athletes themselves about injuries through interviewing could have been confounded by errors in recording by the coaches or errors in reporting by the athletes. But, one strength about the instrumentation in this study was that all ACL injuries were verified by MRI reports or operative notes. Maturation-this study was conducted over the course of one season of soccer or basketball in high school female athletes so the likelihood of changes occurring were minimal. Testing-pre-tests were not done and the outcome measures used relied on reporting about athlete exposures and incidence of injury from coaches and athletes so testing was likely not a threat. Compensatory equalization of treatmentssince blinding of subjects and assessors was not done, this could have been a threat to internal validity through the contact of the research assistants to the coaches in the control teams. Compensatory rivalry-again, since blinding was not done, compensatory rivalry cannot be ruled out. It is unlikely that teams from the different groups practiced together but they could have potentially played each other, in which case, a team from the control group could have seen a team from the intervention group perform this warm-up before a game. In addition, 49

50 the teams in the control group probably knew that they were not in the intervention group since they were instructed to perform their usual warm-up, therefore, the teams in the control group may have changed their behaviors as a result. Statistical regression-statistically significant differences were found at baseline for those participants who provided personal information after parental consent (855 out of 1492 athletes), however these differences did not create statistical regression threats to internal validity because there were no true outliers. Are the results of this therapeutic trial valid? Appraisal Criterion 18. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study s results? Reader s Comments Yes- Cluster randomization with stratification was used because whole teams were investigated. Randomization was done through an online random number generator program. This study was done in high school girls basketball and soccer teams, so schools were stratified by school population, socioeconomic status, and competitive division. In this trial, the cluster randomization did not produce unequal group sizes as there were 45 coaches and 53 teams in each group with 755 athletes in the control group and 737 athletes in the intervention group. Cluster randomization makes sense in this setting because when a warm-up program is implemented (or not implemented in the control group), all the players on the same team should be performing the same warm-up. Stratification before randomization was done because it was thought that factors such as socioeconomic status of the school population and competitive division might affect injury rates due to different playing 50

51 19. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study s results? 20. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 21. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects knowledge for this study s results intensities, overall fitness, and access to medical care. No- This was not specifically reported, stratification was done before allocation but since allocation was randomized it can be assumed that the investigators did not know which teams would be assigned to either the intervention or control groups prior to allocation. Yes- In a table, the demographic characteristics of the athletes who had parental consent were provided, this information was obtained from 855 out of 1492 athletes who completed the study. There actually were a few significant differences between the intervention group and the control group including: more participants from the top 2 competitive divisions, more participants in the intervention group, intervention athletes had lower BMIs, different race/ethnicity distribution, had more playing experience, and were more likely to have played on other sports teams and participated in strength and conditioning programs in the last 3 months. Even though these differences were statistically significant, when looking at the raw numbers (means), the numbers look similar and there were no obvious outliers, so it appears that the groups were similar at baseline. Yes- This was not specifically addressed so it must be assumed that the teams were not blinded as to which group they were in. It could be assumed that the teams from different groups would not practice together but the different warm-ups could have been observed during a game when a team from the intervention group competed against a team from the control group. Communication between groups can also not be ruled out. Finally, the teams in the control group were probably 51

52 22. Did the investigators know to which treatment group subjects were assigned? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 23. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study s results? 24. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study s results? able to identify that they were in the control group since they were instructed to perform their usual warm-up. Yes- It is noted that the research coordinator (who is one of the authors) informed coaches of their allocation, which reveals that he was not blinded to group assignment. In addition, the research assistants (RAs) (who were in contact with the coaches every week) were not blinded to group assignment. It is stated that the principal investigator and coinvestigators were blinded until after data collection was complete to avoid bias in answering RAs questions regarding injury classification. The potential consequences that can occur when investigators are not blinded include the previously mentioned compensatory equalization of treatments or compensatory rivalry. Yes- The teams in the intervention group were instructed to incorporate the neuromuscular warm-up into their practice schedules as well as pre-game routines. The control group was instructed to perform their usual warm-up. The RAs attended team practices biweekly to obtain exposure and injury data as well as observe warm-ups and answer questions. The RAs did spend more time observing the intervention teams than the control teams, though (1 to 3 practices for each intervention team and at least 1 practice for each control team). Yes- The study was conducted over the course of a whole season for basketball and for soccer in high school girls teams. The average length of a season was 13 weeks and injury incidence data was collected weekly during the season. However, no data was collected beyond the end of the season. 52

53 25. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study s findings? 26. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study s results? Are the valid results of this RCT important? Appraisal Criterion 27. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p-values and CI c. Include effect size with p-values and CI d. Include ARR/ABI and RRR/RBI with p-values and CI e. Include NNT and CI f. Other stats should be included here No- As noted previously, 111 teams were randomized initially (54 intervention, 57 control) but in the text of the results section it is noted that 6 teams were excluded from analysis as no data was submitted for those teams. But 106 teams completed the study (53 intervention, 53 control) with 1492 athletes (737 intervention, 755 control). For those teams which dropped out, it was stated that they were excluded from the analysis. This means that those teams were unaccounted for and could have serious implications such as the warm-up actually causing an injury or being too difficult for the athletes to perform correctly. Yes- Even though the teams that dropped out were excluded from the analysis, the statistical methods included intent-to-treat Poisson regression models, therefore, it appears that an intention to treat analysis was done. Reader s Comments The number of injuries were reported as raw numbers and as the rate per 1000 athlete events (AEs) for the intervention and the control groups, then these were compared and p value were reported. The results showed that 96 LE injuries occurred in the control group which was 4.19 per 1000 AEs (95% CI per 1000 AEs). In the intervention group, 50 LE injuries occurred which was 1.78 per 1000 AEs (95% CI per 1000 AEs). LE injuries treated surgically was reported in the entire sample, there were 4 in the control group (0.17 per 1000 AEs) and 0 in the intervention group (0 per 1000 AEs) this was statistically significant with a p value of It was noted that all LE 53

54 28. What is the meaning of these statistical findings for your patient/client s case? What does this mean to your practice? injuries resulting in surgery were ACL tears (all were in the control group). Statistical analysis was performed for both the entire sample and also on the 855 athletes who provided personal information after obtaining parental consent. Similar results were found but in the entire sample the statistically significant findings included lower injury rates in the intervention group for: gradual onset (P <0.01), acute onset (P <0.01), ankle sprains (P=0.01), and LE injuries treated surgically (all were ACL tears) (P=0.04). In the 855 participants who provided personal information statistically significant findings included lower injury rates in the intervention group for: acute onset (P <0.001), ankle sprains (P <0.05), knee sprains (P=0.03), and ACL sprains (P=0.04). Incidence rate ratios (with CIs) were found after adjustment for clustering by team and significant covariates for the following categories related to LE injuries: gradual onset, acute onset, ankle sprains, knee sprains, ACL sprains, and LE injuries treated surgically (all were ACL tears). It was found that the number needed to treat to prevent 1 non-contact ACL injury was 191. It was also found that to prevent 1 non-contact LE injury resulting in surgery, 189 athletes would need to be trained. A dose-response trend was found as it was reported that teams which used the warm-up more frequently had lower rates of acute onset LE injuries but it was not statistically significant (P=0.42). The statistical methods used were not consistent for every comparison, sometimes X 2 was used and sometimes Fisher exact test was used but it is unclear why they were used differently. These statistics demonstrate that this specific warm-up program has potential to help prevent ACL injuries in high school 54

55 29. Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? female athletes playing soccer and basketball. All of the ACL injuries resulting in surgery occurred in the control group which reveals a promising effect of the warm-up to reduce the incidence of injury. However, the NNT is very high which indicates that many teams would need to implement this program in order to prevent one ACL injury that results in surgical repair. The MCID was not discussed, but the intervention group participants had significantly fewer occurrences of ACL injury which seems clinically relevant. Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion Reader s Comments 30. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3 rd party coverage to provide this treatment? 31. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? This prevention warm-up program does seem appropriate for implementing in young female basketball and soccer athletes. It can be done during regular practice time and an abbreviated version can be performed prior to games and additional equipment is not needed. It can be completed by an entire team in about 20 minutes. In addition, it is relatively inexpensive as it was noted that the cost of training a group of 15 to 20 coaches was about $80 per coach (which included personnel time, travel, and coach toolkits). The average age for the 855 participants who provided personal information after obtaining parental consent was about 16 years old. All of the subjects in this study were high school female athletes playing soccer or basketball. This population is somewhat similar to my patient because they are young athletes, however, my patient was a young male athlete who was 21 at the time of his ACL injury. The warm-up program presented in this study provides an idea of the types of preventive exercises used in the young female athlete population. 55

56 32. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 33. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? 34. Are there any threats to external validity in this study? This warm-up program does not seem to increase the risk for lower extremity injury because the intervention group had lower incidence of all lower extremity injuries in all the categories that were analyzed. This study demonstrated significant benefits for injury prevention in many cases, including ACL injuries resulting in surgery. The benefits do outweigh the risks even though the number needed to train to prevent 1 injury requiring surgery was a fairly high number (189). Yes because my patient would have liked to prevent his injury if possible. Since he was playing intramural football for fun though, he would have been less likely to regularly participate in a prevention program such as this one because team sports was not a priority at that point in his life. Yes, this trial investigated a specific population which was high school female athletes participating in basketball and soccer. This study was based in Chicago which provided a mixed-ethnicity, predominately low-income, and urban population. Since this was a very particular population, it is difficult to generalize the results to other age groups and other sports. What is the bottom line? Appraisal Criterion PEDRO score (see scoring at end of form) *This score has been confirmed* Reader s Comments 6/10 Eligibility criteria: Yes Random allocation: Yes Concealed allocation: No Baseline comparability: Yes Blind subjects: No Blind therapists: No Blind assessors: No Adequate follow-up: Yes Intention-to-treat analysis: Yes Between group comparisons: Yes Point estimates and variability: Yes 56

57 Summarize your findings and relate this back to clinical significance Note: Eligibility criteria item does not contribute to total score This study demonstrated reduced incidence of lower extremity injuries for high school female soccer and basketball athletes in the intervention group who were participating in a neuromuscular warm-up over the course of one season. Of interest, no ACL injuries resulting in surgery occurred in the intervention group and the intervention group had significantly fewer ACL sprains. These results show the potential effectiveness of this neuromuscular warm-up in this population but the number of athletes needed to be trained in order to prevent one lower extremity injury resulting in surgery was quite high (189). It would be feasible to implement though as it requires no additional equipment, minimal training for coaches, and takes about 20 minutes for a team to complete; in addition, it does not seem to have any adverse effects. However, some threats to internal and external validity were found so the results from this study may not be generalizable to other populations. 57

58 Intervention Evidence Appraisal Worksheet Citation: Waldén, M., Atroshi, I., Magnusson, H., Wagner, P., & Hägglund, M. (2012). Prevention of acute knee injuries in adolescent female football players: cluster randomised controlled trial. BMJ: British Medical Journal (Clinical Research Edition), 2012;344:e3042. doi: /bmj.e3042 Level of Evidence (Oxford scale): 1b Is the purpose and background information sufficient? Appraisal Criterion Reader s Comments Study Purpose Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Yes- The purpose was stated clearly in both the abstract and introduction sections. In the abstract the objective was to evaluate the effectiveness of neuromuscular training in reducing the rate of acute knee injury in adolescent female football players. This study was done in Sweden and football referred to soccer. In the abstract, the objective was stated very similarly but it specifies that the rate of ACL injuries was the outcome of interest. It was also hypothesized that the rates of ACL injury and acute knee injury would be significantly reduced in the intervention group compared with the control group. The neuromuscular warm-up used in this study took about 15 minutes to complete and targeted core stability, balance, and proper knee alignment. The exercises given followed a very specific progression (level 1-4 for each exercise). There were six exercises, including: one legged knee squat, the bench, the lunge, and jump/landing technique. Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study Yes- The background information was presented in the introduction section; it was brief but meaningful. It was noted that soccer is the most popular sport in the world and that the number of young females participating in soccer has grown rapidly. In addition, the increased knee injury rate, particularly ACL injuries, among 58

59 Does the research design have strong internal validity? Appraisal Criterion Reader s Comments Discuss possible threats to internal validity in the research design. Include: Assignment minimized. Attrition History Instrumentation Maturation Testing Compensatory Equalization of treatments Compensatory rivalry Statistical Regression 59 young female athletes was discussed. Finally, it was noted that there were few other randomized controlled trials which had investigated the use of neuromuscular training programs specifically for ACL injury prevention. Assignment-was random and the sample size was large so internal validity threats associated with assignment were Attrition-a flow chart was presented which explained the attrition for this study. 309 soccer clubs were randomized (154 intervention, 155 control) but shortly after, 18 of those (10 intervention, 8 control) were dissolved before the start of league play and did not enter the trial. Therefore, 144 intervention clubs and 147 control clubs entered the trial. In the intervention group, 23 clubs were lost to follow-up and 23 clubs were not interested. In the control group, 38 clubs were lost to followup, 36 clubs were not interested, and 2 clubs had missing baseline questionnaires. In the end, 121 clubs with 2479 players were analyzed in the intervention group and 109 clubs with 2085 players were analyzed in the control group. Excluding the clubs that were dissolved prior the start of the study, the dropout rate was 21%. This study had a fairly high attrition rate, but it still ended with a very large sample size. But excluding clubs that were randomized from data analysis could have been a threat to internal validity. History-no external events were noted so threats here were minimal. Instrumentation-injury surveillance included a baseline questionnaire, players attendance, and injury registration. Coaches of the clubs in both the intervention and control groups were

60 responsible for registering individual playing time (registered as minutes of actual participation for each player) and absences for each training session and match during the season. This was done through a computer based player s attendance form and this data was ed to the study therapist and two of the authors. Sixty-eight study therapists (physical therapists) were recruited to assist coaches with data collection and recorded injuries. Eight study physicians were also recruited to assist with diagnosing injuries. The study therapists trained each coach and one player for each team on the neuromuscular warm-up for the clubs in the intervention group. Definitions were provided for acute knee injuries, severe injuries, and anterior cruciate ligament injuries. All complete ACL tears were confirmed through MRI except one which was confirmed during ACL reconstruction. The instrumentation for this study does present threats to internal validity because the investigators created their own definitions for what constitutes an injury, in addition, the data collection method was not a validated outcome measure. Maturation-this study was conducted over the course of one season of soccer in young female athletes so the likelihood of changes occurring were minimal. Testing-pre-tests were not done and the outcome measures used relied on reporting about individual playing time and incidence of injury from coaches and study therapists so testing was likely not a threat. Compensatory equalization of treatmentssince blinding of subjects and study therapists was not done, this could have been a threat to internal validity through the contact of the study therapists to the coaches in the control teams. 60

61 Compensatory rivalry-again, since blinding was not done, compensatory rivalry cannot be ruled out. It is unlikely that teams from the different groups practiced together but the teams in the control group probably knew that they were not in the intervention group since they were instructed to perform their usual warm-up, therefore, the teams in the control group may have changed their behaviors as a result. Statistical regression-baseline characteristics were similar between groups with no outliers, therefore, statistical regression threats to internal validity were limited. Are the results of this therapeutic trial valid? Appraisal Criterion 35. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study s results? 36. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study s results? Reader s Comments Yes- Cluster randomization was used due to the team setting and to minimize contamination between the intervention and control group. A computer generated list of random numbers was used to randomize the clubs and they were stratified by district (all teams from the same club were assigned to the same group). Stratification by district was chosen to account for variations in league systems (like competitive level or age level) between districts. The population for this study was soccer clubs (a club could include multiple teams) with female athletes ages years old. No- It was noted that randomization was revealed after recruitment of the final club to ensure concealment of allocation. For this reason and due to the fact that randomization was performed, the investigators did not know who was being assigned to which group prior to the allocation. 61

62 37. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 38. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 39. Did the investigators know to which treatment group subjects were assigned? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 40. Were the groups managed equally, apart from the actual experimental treatment? 62 Yes- Baseline characteristics were provided for many different categories in a table and the data indicate that the groups were similar at baseline. However, this table did not list p values for any of the items, so it was unclear if there were any statistically significant differences between groups prior to the start of the trial. In the results section, it was stated that the players in the two groups who completed the study were similar in terms of baseline characteristics. Yes- There was no blinding of subjects because even though the teams of the different groups likely did not interact with one another, the teams in the control group probably easily identified that they were not in the intervention group because they were instructed to train and play as usual throughout the season without any changes. One potential consequence could include compensatory rivalry, as mentioned previously. Yes- Although, it is stated that the author who performed the randomization was blinded to the identity of the clubs. In addition, it is noted that the two authors who were not involved in the intervention or data collection did the intention to treat analysis with group identity concealed. But two authors were not blinded to group assignment and the study therapists who interacted with coaches and players were also not blinded to group assignment. One potential consequence for lack of blinding to group assignment with the investigators could include compensatory equalization of treatments, as previously mentioned. Yes- The teams in the intervention group were asked to perform this specific neuromuscular warm-up at two training

63 a. If not, what are the potential consequences of this knowledge for the study s results? 41. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study s results? 42. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study s findings? sessions per week throughout a full season of playing. The exercises in the neuromuscular warm-up followed a specific progression and the coaches were taught the exercises initially, in addition, they were provided with instructional materials. The study therapists instructed the coaches carefully on how to make sure players were ready to move on to the next exercise in the progression. The teams in the control group were instructed to train and play as usual throughout the season without any changes. Data about individual playing time and absences from playing was sent through by coaches of both groups to the investigators monthly. Finally, coaches of both groups reported knee injuries to the study therapists and the severity and type of injuries were determined. No- The study was conducted over the course of one season for female soccer players which lasted about seven months. Data about playing time and injuries were collected monthly during the season but no data was collected beyond that point. Since there was not sufficient follow-up, it is unknown if this neuromuscular warm-up program could have preventive effects even after it is terminated. No- As mentioned previously, 309 soccer clubs were randomized (154 intervention, 155 control) but 18 of those were dissolved before the start of league play and did not enter the trial. Therefore, 291 clubs entered the trail (144 intervention, 147 control) but 46 clubs in the intervention group were not analyzed (23 lost to follow-up, 23 not interested) and 76 clubs in the control group were not analyzed (38 lost to follow-up, 36 not interested, and 2 were missing baseline questionnaires). The investigators were left with 121 clubs in the intervention 63

64 43. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study s results? Are the valid results of this RCT important? Appraisal Criterion 44. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p-values and CI c. Include effect size with p-values and CI d. Include ARR/ABI and RRR/RBI with p-values and CI e. Include NNT and CI f. Other stats should be included here group and 109 clubs in the control group to ultimately analyze (2479 players in intervention group, 2085 players in control group). Excluding the clubs that were dissolved prior to the start of the season, the dropout frequency was 21%. Even though attrition did occur in this trial, the sample size was still very large in the end and an intention to treat analysis was done. Yes- The statistical methods for this study included unadjusted intention to treat analysis using Cox regression. Reader s Comments During 278,298 hours of soccer, 96 knee injuries were recorded (49 intervention, 47 control). Twenty-one ACL injuries occurred out of 4564 participants (0.46%). Out of those 21 ACL injuries, 14 occurred in the control group and 7 occurred in the intervention group. By Cox regression analysis according to intention to treat, a statistically significant 64% reduction in the rate of ACL injury was seen in the intervention group (rate ratio 0.36; 95% CI , P=0.02) The absolute rate difference did not reach statistical significance but was (95% CI to 0.001) per 1000 playing hours in favor of the intervention group and the corresponding number needed to treat was 14. This meant that for every 14 players who received this warm-up program, one less ACL injury would occur per 1000 playing hours. The adjusted subgroup analyses of compliant players (those who completed the program at least once a week) showed a statistically significant 83% rate 64

65 45. What is the meaning of these statistical findings for your patient/client s case? What does this mean to your practice? 46. Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? 65 reduction in ACL injury (rate ratio 0.17; 95% CI , P=0.004). No statistically significant differences were found between the intervention group and control group for secondary outcome measures (severe knee injuries and any acute knee injuries). However, when the compliant subgroup was analyzed, a preventive effect was found in the intervention group for severe knee injuries (rate ratio 0.18; 95% CI , P<0.001) and any acute knee injuries (rate ratio 0.53; 95% CI , P=0.03). Finally, exploratory analyses of noncontact ACL injuries showed a reduction in rates favoring the intervention group; this was statistically significant only for the adjusted subgroup analysis of compliant players (rate ratio 0.26; 95% CI , P=0.049). These statistics revealed a significant reduction in the overall rate of ACL injuries in the intervention group by 64%. Therefore, this neuromuscular warm-up program was effective for reducing incidence of ACL injuries in young female soccer players. The MCID was not discussed, but the intervention group participants had significantly fewer occurrences of ACL injury which seems clinically relevant. Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion Reader s Comments 47. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3 rd party coverage to provide this treatment? This warm-up program does seem appropriate to implement in young female soccer players because it requires no additional equipment to complete and requires minimal training for coaches. It takes about 15 minutes for a team to complete and is recommended to be performed twice a week during practice, which seems very reasonable. The challenging aspect of this program seems to be the progression of exercises. There

66 48. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 49. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 50. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? 51. Are there any threats to external validity in this study? 66 are 6 main exercises and each exercise has 4 levels; a player should be moved to the next level after mastering the technique and form for the current level. Progressing players individually could be potentially difficult for coaches and making sure to watch for correct form and technique for each level could also be challenging. The average age for the athletes in this study was around 14, they were all playing competitive soccer, and they were all females. The subjects were slightly different than my patient who was a male, he was 21 years old when his ACL injury occurred, and he was playing intramural football. But this study provides a good example of an ACL prevention warm-up program to compare to those that have been developed for males. This warm-up program did not seem to increase the risk of injury (ACL or other) as no injury occurred during the execution of the program and there were fewer ACL injuries as well as fewer severe knee injuries in the intervention group than in the control group. The potential benefits do outweigh the risks because it significantly reduced the rate of ACL injury compared to standard warm-up programs used in the control group. The number needed to treat was found to be 14 but this number should be interpreted with caution because the absolute rate difference did not reach statistical significance. Yes because my patient would have liked to prevent his injury if possible. Since he was playing intramural football for fun though, he would have been less likely to regularly participate in a prevention program such as this one because team sports was not a priority at that point in his life. Yes, this trial investigated the implementation of a neuromuscular warm-

67 up program for young (12-17 years old) female soccer athletes. Therefore, the results of this study may not be generalizable to other sports, other age groups, or male athletes. What is the bottom line? Appraisal Criterion PEDRO score (see scoring at end of form) *This score has been confirmed* Reader s Comments 7/10 Eligibility criteria: Yes Random allocation: Yes Concealed allocation: Yes Baseline comparability: Yes Blind subjects: No Blind therapists: No Blind assessors: Yes Adequate follow-up: No Intention-to-treat analysis: Yes Between group comparisons: Yes Point estimates and variability: Yes Note: Eligibility criteria item does not contribute to total score Summarize your findings and relate this back to clinical significance This study demonstrated a statistically significant reduction of 64% in the rate of ACL injury in the intervention group, therefore, this appears to be an effective prevention warm-up program for young female soccer athletes. Overall, this program would be feasible to incorporate into soccer team practices as it does not require additional equipment, requires minimal training for coaches, takes 15 minutes for a team to complete, and was suggested to be performed twice a week. The progression of the 6 basic exercises could be potentially challenging for coaches because individual athletes would likely be progressed at different rates, therefore, it might be difficult to keep up with and watching for correct form and technique could be challenging, too. This trial had a large sample size and had a good design through blinded assessors and the use of intention to treat analysis. However, a few threats to internal and 67

68 68 external validity were found so the results of this study may not be generalizable to other populations.

69 Systematic Review Evidence Appraisal Worksheet Citation: Yoo, J., Lim, B., Ha, M., Lee, S., Oh, S., Lee, Y., & Kim, J. (2010). A meta-analysis of the effect of neuromuscular training on the prevention of the anterior cruciate ligament injury in female athletes. Knee Surgery, Sports Traumatology, Arthroscopy, 18(6), p. doi: /s Level of Evidence (Oxford scale): 1a Does the design follow the Cochrane method? Appraisal Criterion Step 1 formulating the question Do the authors identify the focus of the review A clearly defined question should specify the types of: people (participants), interventions or exposures, outcomes that are of interest studies that are relevant to answering the question Step 2 locating studies Should identify ALL relevant literature Did they include multiple databases? Was the search strategy defined and include: o Bibliographic databases used as well as hand searching o Terms (key words and index terms) o Citation searching: reference lists o Contact with experts to identify grey literature (body of materials that cannot be found easily through conventional channels such as publishers) o Sources for grey literature Reader s Comments Yes- The purpose of this review is clearly stated in both the abstract and the introduction. The goal was to evaluate the effectiveness of neuromuscular warm-up programs on the prevention of ACL injuries in female athletes. In this case, the people (or participants) were female athletes; the interventions were neuromuscular warm-up programs; the outcome was ACL injury rates; and the investigators analyzed 7 studies in attempt to answer this question. It was stated that as of June 2007, a computerized Medline search was conducted using multiple search term combinations. In addition, the Cochrane Database for Systematic Reviews was also searched; the investigators performed a manual search of journals published in English and Korean; the proceedings of the American Academy of Orthopaedic Surgeons and textbooks were scrutinized manually; and experts interested in ACL injury preventive neuromuscular training programs were consulted for additional studies that may have been missed. It seems as though this team of investigators took several measures to make sure that all the relevant articles were found, however, it appears that the use of multiple databases did not occur (like CINAHL, Web of Knowledge, etc.). Ultimately, only RCTs and prospective cohort studies were included. 69

70 Part 3:Critical Appraisal/Criteria for Inclusion Were criteria for selection specified? Did more than one author assess the relevance of each report Were decisions concerning relevance described; completed by non-experts, or both? Did the people assessing the relevance of studies know the names of the authors, institutions, journal of publication and results when they apply the inclusion criteria? Or is it blind? Part 3 Critically appraise for bias: Selection Were the groups in the study selected differently? Random? Concealed? Performance- Did the groups in the study receive different treatment? Was there blinding? Attrition Were the groups similar at the end of the study? Account for drop outs? Detection Did the study selectively report the results? 70 Criteria for selection was not specified but it was noted that many articles were excluded after reviewing the abstract and then more studies were further excluded after review of full text, done by the evaluation committee. More than one author did assess the relevance of each report as it is noted that each member of the evaluation committee scrutinized the identified articles and categorized each one by marking A: included in the current study, B: considered including after committee discussion, favorable, C: decided after committee discussion, unfavorable, D: excluded from the study, according to the relevance of the study. The evaluation committee consisted of three orthopaedic surgeons and one biomechanical investigator, all of whom had considerable experience in the care of ACL injuries. Decisions concerning relevance of the studies was not really addressed but it seems as though the investigators who made decisions about relevance were experts in this area of study. When applying the inclusion criteria, it was not reported if this was done blindly or not, therefore, it is assumed that this part of the process was not blinded. This was not formally discussed within the review; however, it is noted that only RCTs and prospective cohort studies were included for analysis. But, identification of which studies are RCTs and which are prospective cohort studies did not occur. Therefore, it is unknown how the groups in each study were selected. In all studies, there was a trained group and an untrained group in which the trained group implemented some sort of neuromuscular warm-up program and the untrained group, presumably, changed nothing. In these situations, blinding of subjects cannot be assumed because those in the untrained group probably

71 Is there missing data? knew they were not receiving the treatment because they were likely told to perform their usual warm-up. Attrition rates of the individual studies was not addressed at all. It does not appear that the investigators Part 4 Collection of the data Was a collection data form used and is it included? Are the studies coded and is the data coding easy to follow? Were studies identified that were excluded & did they give reasons why (i.e., which criteria they failed). selectively reported data. It does not appear that a specific data collection form was used but in all studies, the investigators reported the age of the participants, type of sport, training time (whether pre-season or in-season or both), and the biomechanical component(s) that the program utilized (plyometric, strengthening, balancing, or agility). The studies were not coded, but they were referred to by last name of the first author. The reasoning for exclusion was unclear other than relevance, but that was not clearly defined, either. In a flow chart, it was noted that 2215 studies were found to be potentially relevant from the literature search and hand searches but 2184 of these were excluded on the basis of the abstract. From there, 31 studies were selected for full text review but 24 of those were excluded following full text review. Finally, 7 studies were deemed eligible and were included in this review for analysis. Are the results of this SR valid? Appraisal Criterion 52. Is this a SR of randomized trials? Did they limit this to high quality studies at the top of the hierarchies a. If not, what types of studies were included? b. What are the potential consequences of including these studies for this review s results? Reader s Comments This review included 7 studies and only RCTs and prospective cohort studies were selected. However, the studies which were RCTs and the studies which were prospective cohorts was not distinguished. The potential consequence when RCTs are not the only type of study included in a review is that the highest quality of evidence was not utilized, therefore, the results may not have as much significance. 71

72 53. Did this study follow the Cochrane methods selection process and did it identify all relevant trials? a. If not, what are the consequences for this review s results? 54. Do the methods describe the processes and tools used to assess the quality of individual studies? a. If not, what are the consequences for this review s results? 55. What was the quality of the individual studies included? Were the results consistent from study to study? Did the investigators provide details about the research validity or quality of the studies included in review? This review does seem to follow the Cochrane methods selection process with a few exceptions. The criteria for inclusion could have been more clearly defined and a couple more things could have been reported in further detail such as: assignment (random, concealed) and attrition. It seems as though all relevant articles were identified due to use of many search terms and the reviewing of over 2000 abstracts. It was noted that identified articles were evaluated by grading level of evidence (1-5). Also, as mentioned before, each member of the evaluation committee categorized each study as: A) included in the current study, B) considered after committee discussion, favorable, C) decided after committee discussion, unfavorable, and D) excluded from the study, according to relevance. However, a rating system, such as PEDro was not utilized to assess quality of individual studies. In addition, prospective cohort studies were included which means that some of the articles were a lower level of evidence to begin with. The potential consequence of not using the highest level of evidence could have resulted in an overestimate of the treatment effect. As mentioned before, 7 studies were included in this review and only RCTs and prospective cohort studies were selected for inclusion. The results were not consistent as five of the seven articles supported the efficacy of neuromuscular injury prevention programs while the other two studies did not. The investigators did not provide detailed information regarding the research validity or quality of the studies included in this review. In fact, it was not clear which studies out of the seven were RCTs and 72

73 56. Did the investigators address publication bias Are the valid results of this SR important? Appraisal Criterion 57. Were the results homogenous from study to study? a. If not, what are the consequences for this review s results? 58. If the paper is a meta-analysis did they report the statistical results? Did they include a forest plot? What other statistics do they include? Are there CIs? which studies were prospective cohort studies. Yes- In the methods section of this review, it stated publication bias was assessed using the Egger regression asymmetry test and the Begg and Mazumdar adjusted rank correlation test. In a figure, one Begg s funnel plot for publication bias was provided; it appears quite symmetrical indicating a low risk for the occurrence of publication bias. It was reported that no significant publication bias was evident. Reader s Comments Homogeneity must have been found between the studies in this review because a meta-analysis was done. In the methods section, it was stated that heterogeneity between studies was tested using the chi-square test. Forest plots were provided for a fixed model and for a random model. In the results section, it was stated no significant heterogeneity was found among studies. However, two of the seven studies included in this review do not support the efficacy of ACL injury prevention programs (this can be seen in the forest plots). Yes- Statistical results, forest plots, and CIs are reported, in addition to odds ratios. Forest plots are provided on final page of this article analysis worksheet. The meta-analysis was conducted by pooling the data from the seven studies which were included and this revealed that the incidence of ACL injury was 34 of 3,999 in the trained group and 123 of 6,462 in the untrained group with an odds ratio (OR) of 0.40 and 95% CI of in the fixed model, which demonstrated the effectiveness of the preventative training. 73

74 59. From the findings, is it apparent what the cumulative weight of the evidence is? 74 The subgroup analysis results were as follows: the OR [95% CI] of subjects under the age of 18 was 0.27 [ ] and training among these subjects showed a more favorable effect than on adults with 0.78 [ ]; training had more effect on soccer 0.32 [ ] than on handball 0.54 [ ]; pre- and inseason training 0.54 [ ] was effective while pre-season training 0.35 [ ] or in-season training 0.32 [ ] was not; the plyometric 0.37 [ ] and strengthening components of training protocol [0.21 [ ] vs [ ]] were effective whereas balancing [0.63 [ ] vs [ ]] was not. The weight of the evidence based on the studies used in this review suggest that neuromuscular warm-up programs are effective for preventing ACL injuries in female athletes. The favorable effect of training was more prominent in those under the age of 18, in soccer rather than handball, and when performed in both the pre-season and during the season rather than pre- or in-season alone. In addition, plyometric and strengthening exercises were found to be more essential to training programs than balance exercises. Can you apply this valid, important evidence from this SR in caring for your patient/client? What is the external validity? Appraisal Criterion Reader s Comments 60. Is your patient different from those in this SR? The ages of the subjects in this review ranged from 14 to 35 but many of the athletes were in the age range. The sports included in this review were soccer, handball, and volleyball. In addition, all subjects in this study were females. My patient was a 21 year old male at the time of injury and he was playing intramural football. Therefore, my patient is somewhat different than the participants in this study but this review provides information about the types of ACL prevention programs that have been

75 61. Is the treatment feasible in your setting? Do you have the facilities, skill set, time, 3 rd party coverage to provide this treatment? 62. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? developed and investigated in female athlete populations. The specific exercises and time required to complete the programs were not provided for each individual study in this review but it seems as though these type of programs were feasible to implement and typically required minimal training for coaches. Yes because my patient would have liked to prevent his injury if possible but he might have been less likely to incorporate some type of prevention program into his routine as his injury occurred while playing intramural football, which he was doing just for fun. What is the bottom line? Appraisal Criterion Summarize your findings and relate this back to clinical significance Reader s Comments This review with meta-analysis investigated seven studies (RCTs and prospective cohort studies) and the results demonstrated that neuromuscular warmup programs were effective for preventing ACL injuries in female athletes. In addition, subgroup analysis showed that an age under 18, soccer rather than handball, pre- and in- season training rather than either pre- or in- season training alone, and that plyometrics and strengthening components rather than balance exercises were significant. This review provided minimal detail about the individual studies as far as assignment and attrition, furthermore, the criteria used for inclusion and exclusion was not clearly defined. Overall, this review provided evidence to support the use of ACL injury prevention programs in female athletes, particularly in those under 18 and playing soccer. In addition, the use of a training program was more effective when used in the pre-season and during the season and use of plyometric and strengthening exercises were more effective than balance exercises. 75

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