Sacroiliac Joint Pain: Evidence Based Diagnosis and Treatment Options

Transcription

1 Sacroiliac Joint Pain: Evidence Based Diagnosis and Treatment Options Raj Sureja M.D. Interventional Pain Management Orthopaedic & Spine Center September 11,

2 Program Overview What is the sacroiliac joint? Prevalence of sacroiliac joint pain How to establish the diagnosis? What are the treatment options? 2

3 The Sacroiliac Joint Lies next to the bottom of the spine, below the lumbar spine and above the tailbone (coccyx) Connects sacrum (sacro-) with the pelvis (-iliac) Characteristics: Small and very strong, reinforced by strong ligaments that surround it Minimal motion Transmits forces of the upper body to the pelvis (hips) and legs Shock-absorbing structure 3

4 SIJ pain symptoms May be characterized by the following: Pain in the thigh and/or buttock, and possibly pain that radiates down the sciatic nerve, although it rarely radiates into the foot More commonly experienced on one side of the body, but may occur on both sides Typically characterized by stabbing pain 4

5 Prevalence of SI Joint Pain 13-30% incidence of SIJ pain in LBP patients Schwarzer AC. Spine % incidence of SIJ pain in LBP patients Maigne JY. Spine % of patients with axial LBP have SI joint pain Cohen SP. Anesth Analg % incidence of SIJ pain in LBP patients Irwin RW. Am J Physical Medicine & Rehabilitation 2007 Bernard Clinical Orthopedic & Related Research 1987 (N=1,293 pts) 5

6 Prevalence of SI Joint Pain Post-Fusion 1 Failed Back Surgery 2 1. DePalma MJ, et al. Pain Medicine 2011; Volume 12, Issue 5, Katz. The Sacroiliac Joint: A Potential Cause of Pain After Lumbar Fusion to the Sacrum. J Spinal Disord Tech Feb;16(1):96-9 6

7 Diagnosing SI Joint Pain 7

8 SI Joint Diagnostic Challenges Presenting complaints mimic other causes of chronic LBP Evaluate all possible pain generators for the lumbar spine, the hip, and the SI Joint Imaging studies often inconclusive Referral pain patterns for the three conditions overlap Lumbar-SI-Hip Axis 8

9 Who Are the SIJ Patients? Is there clinical evidence for how to diagnosis? 9

10 Diagnosing Overview History Physical exam Differential diagnosis Current reference standard 10

11 History: Potential Causes TRAUMATIC Fall Motor vehicle collision Lifting Pregnancy ATRAUMATIC Adjacent Segment Disorder Prior Lumbar Fusion Cumulative Injury Arthritis Obesity Scoliosis Inflammatory Arthropathy Infection 11

12 The SI Joint in Adjacent Segment Disease Fusion of the spine has an effect on adjacent segments because there are changes in the motion required of these segments and in the stress they receive. The SI joint is located at the base of the spine and its movements are influenced by the motion of the spine. PREVALENCE SI Joint Degeneration Radiographic Evidence 5 years Post- Fusion Symptomatic SI Joint 1-year M edian Duration Post-Lumbar Fusion The sacroiliac joint may be a contributing factor in 29% to 40% of cases of failed back surgery syndrome.

13 Sacroiliac Joint Disruptions Due to Minor Trauma During the physical exam, one of the most common findings of patients with sacroiliac (SI) joint pain is a history of minor trauma. Trauma to the SI joint may occur from one incident (fall to the buttocks, motor vehicle accident, pregnancy) or from repeated stress over time (sports related, heavy lifting, torsional strain). PREVALENCE Minor Trauma Cumulative Injury Prevalence of SI Joint Injury Work Related Injury

14 Physical Exam: Pain Localization Fortin Finger Test 1 Point to pain while standing 1. Able to localize pain with one finger 2. Within 1 cm of PSIS (inferomedial) 3. Consistent over at least 2 trials Ask patient to point to location of primary pain Below L5: Consider SIJ Above L5: Consider lumbar spine etiologies From Forst SL et al. Pain Physician Fortin JD. Am J Orthop 1997;26(7):

15 SI Joint Pain Referred Patterns Primary Below L5 Pain over PSIS 14% Groin 94% Buttock 28% Lower Leg SIJ-related pain patterns can be similar to the L5 and S1 dermatome areas 12% Ankle 48% Thigh Slipman, et al. Sacroiliac Joint Syndrome. Pain Physician 2001;4:2, pp

16 Sacroiliac Provocation Tests Compression Thigh thrust Distraction FABER Gaenslen s 16

17 Sacroiliac Provocation Tests Provocative Tests 1. Distraction* 2. Thigh Thrust* 3. Compression 4. FABER 5. Gaenslen s Maneuver * most sensitive of the tests Diagnostic Criteria: 3 of 5 must be positive At least 1 of 3 being Compression or Thigh Thrust 1 Laslett (2) Szadek (1) Sensitivity 91% 85% Specificity 78% 76% 1. Diagnostic Validity of Criteria for Sacroiliac Joint Pain: A Systematic Review Karolina M. Szadek, M.D. et al. The Journal of Pain: Official Journal of the American Pain Society 10, no. 4 (April 2009): Evidence Based Diagnosis and treatment of the painful Sacroiliac Joint - Journal of Manual & Manipulative Therapy, 2008, Mark Laslett 17

18 Conservative Treatment Options 18

19 Treatment Options Drugs NSAIDS Oral steroid taper Opioids (acute pain) Therapeutic Injection 1-4 per year Radiofrequency Ablation Physical Rehabilitation 6-8 weeks duration Manual Therapy SIJ Belt Postural modifications 19

20 Physical Therapy Structured Exercise Program Dramatic Improvement Patient with Chronic Pain Results after treatment No or Minimal Improvement Disability due to Low Back Pain Results after treatment No disability after treatment Modest Improvement 2 year outcomes: Physical therapy exercise produced good long term results Chronic or Disability due to LBP saw no to modest improvements This subset could be due to an underlying disruption Sasso et al. Sacroiliac Joint Dysfunction: A Long Term Follow Up Study. Orthopedics. 2001;24: Some or no change after treatment 20

21 Diagnostic SIJ Injections Current Gold Standard 22 gauge 5 styletted needle 0.25ml contrast medium 1.25ml local anesthetic AP inferior SIJ target AP needle in SIJ target before contrast Pain Reduction 75% test is positive 50-75% May be considered a major contributor to the patient s pain AP needle in SIJ Lateral needle in SIJ after contrast 21

22 SI Joint Injections % pts with relief Maugars 1996 Only randomized control study Spondylarthropathy patients diagnosed with sacroiliitis Maugars, et al. Assessment of the efficacy of sacroiliac corticosteroid injections in spondylarthropathies: a double blind study. Br J Rheumatol Aug;35(8):

23 SI Joint Injections Hawkins 2009 SIJ corticosteroid injections appear to be an effective palliative treatment for selected patients with SIJ pain. Most patients whose pain is responsive to SIJ steroid injections improved sufficiently and remained well after 1 to 3 injections, but some required frequent injections on a long-term basis (duration between injections: 8.5 months) Hawkins, et al. Serial Therapeutic Sacroiliac Joint Injections: A Practice Audit Pain Med Jul-Aug;10(5):

24 RF for SI Joint Pain Patel, et al Patients randomized 2:1 True RF group had greater decrease in pain at 3 months (2.4 points vs. 0.8 points), and also had greater improvement on Oswestry (decrease of 11 points vs. increase of 2 points) than the sham RF * P < 0.05 comparing means between treatment and sham groups 24 Patel, et al. A Randomized, Placebo Controlled Study to Assess the Efficacy of Lateral Branch Neurotomy for Chronic Sacroiliac Joint Pain. Pain Med Mar;13(3):383 98

25 RF for SI Joint Pain Cheng et al patients 30 traditional RF 58 cooled RF Cohen et al patients benefit constrained by nerve regeneration to between 6 months and 1 yr. Cheng, et al. Comparative outcomes of cooled versus traditional radiofrequency ablation of the lateral branches for sacroiliac joint pain.clin J Pain Feb;29(2):132 7 Cohen, et al. Randomized Placebo controlled Study Evaluating Lateral Branch Radiofrequency Denervation for Sacroiliac Joint Pain. Anesthesiology 2008; 109:

26 Treatment Options Recurrent Pain? May have underlying disruptions Disruptions can cause instability through: 1 ligamentous laxity tearing of the joint capsule up to 61% of patients had capsular tears 2,3 Is there another option? 1. Laslett, M. Evidence-Based Diagnosis and Treatment of the Painful Sacroiliac Joint. J Man Manip Ther. 2008; 16(3): Fortin JD, Sacroiliac joint: Pain referral maps upon applying a new injection/arthrography technique. Part II: Clinical evaluation. Spine 1994;19: Schwarzer AC. The sacroiliac joint in chronic low back pain. Spine 1995;20:

27 Sacroiliac Joint Fusion 27

28 SI Joint Fusion Minimally Invasive ifuse Implant System Vs. Open SI Fusion: Small incision Reduced blood loss Short procedure length ~ 1 hour No need for bone grafting 28

29 SI Joint Fusion: ifuse Implant System Why the unique triangular design? Cannulated screw may loosen 1,2,3 Design: Triangle vs. Round Porous titanium plasma coating allows for biologic fixation Larger surface area designed to stabilize and fuse the heavily loaded SI joint 3X stronger than screw 4 1. The Effects of Cyclic Loading on Pull-Out Strength of Sacral Screw Fixation: An In Vitro Biomechanical Study 2. Lu et. Al Loosening of sacral screw fixation under in vitro fatigue loading J Ortho Research Wheeless' Textbook of Orthopaedics. By CR Wheeless 4. Mauldin G. Strength of Materials of the SI-BONE ifuse Implant Vs. 8.0 mm Cannulated Screw. Dec 2009 (data on file). 29

30 ifuse Clinical Results Clinical Publications (10) Outcome Measures Pain Visual Analog Scale (VAS) Back Function Oswestry Disability Index (ODI) Quality of life SF-12, SF-36, EQ-5D, RDQ Patient Satisfaction Perioperative EBL, OR time, LOS Complaints / Complications 30

31 ifuse Procedure Outcomes 3 year: Early and Sustained 1 1. Rudolf*, Sacroiliac Joint Arthrodesis-MIS Technique with Titanium Implants: Report of the First 50 Patients and Outcomes. The Open Orthopaedics Journal, 2012, 6, *Dr. Rudolf is a paid consultant and has an ownership interest in SI-BONE, Inc. 31

32 Pain Relief: Rapid & Sustained Disclosures: Rudolf Paid consultant of, ownership interest in, and conducts clinical research for SI BONE Inc. Sachs Paid consultant of and conducts clinical research for SI BONE Inc. Cummings Paid consultant of and conducts clinical research for SI BONE Inc. Duhon Paid consultant of and conducts clinical research for SI BONE Inc. 32

33 ifuse Procedure Outcomes Cummings*, et al. Minimally invasive sacroiliac joint fusion: one-year outcomes in 18 patients. Ann Surg Innov Res. 2013; 7: 12 *Paid consultant of and conducts clinical research for SI-BONE Inc. 33

34 Oswestry Disability Index (ODI) Questionnaire used by clinicians and researchers to quantify disability for low back pain Questionnaire contains topics concerning: intensity of pain lifting, ability to care for oneself ability to walk ability to sit sexual function ability to stand social life sleep quality ability to travel Each question is scored on a scale of 0-5: zero indicates the least amount of disability 5 indicates most severe disability The index is scored from 0 to 100. Zero is equated with no disability and 100 being maximum disability 34

35 ODI (continued) 0% to 20%: Minimal disability 21%-40%: Moderate Disability 41%-60%: Severe Disability 61%-80%: Crippling back pain 81%-100%: These patients are either bedbound or have an exaggeration of their symptoms 35

36 Back Function: Clinical Improvement Oswestry Disability Index (ODI) Cummings 2013 (n=18) ODI Drop from BL to 12mo Gaetani 2013 (n=10) ODI Drop from BL to mean 10mo Duhon 2013 (n=26) ODI Drop from BL to 6mo Clinically & Statistically Significant Improvement Clinical Improvement Definitions *MCID: 12.8 point drop [1] 37.5 pts* (p<0.001) 19.4 pts* (p<0.001) 15.8 pts* (p<0.0001) SCB: 18.8 point drop or final score of < 31.3 [2] MCID = Minimal Clinical Important Difference SCB = Substantial Clinical Benefit Disclosures: Cummings Paid consultant of and conducts clinical research for SI BONE Inc. Gaetani Conducts clinical research for SI BONE Inc. Duhon Paid consultant of and conducts clinical research for SI BONE Inc. [1] Copay AG, et al. Spine J 2008; 8(6): [2] Glassman SD, et al. J Bone Joint Surg 2008; 90(9):

37 ifuse Procedure Outcomes Multiple Studies: High patient satisfaction 1. Rudolf* et al., Sacroiliac Joint Arthrodesis-MIS Technique with Titanium Implants: Report of the First 50 Patients and Outcomes. The Open Orthopaedics Journal, 2012, 6, Duhon* et all. Safety and 6-month effectiveness of minimally invasive sacroiliac joint fusion: a prospective study. Med Devices (Auckl) Dec 13;6: Cummings*, et al. Minimally invasive sacroiliac joint fusion: one-year outcomes in 18 patients. Ann Surg Innov Res. 2013; 7:12 4. Sachs*, et al. Minimally Invasive Sacroiliac Joint Fusion: One-Year Outcomes in 40 Patients. Ann Surg Innov Res. 2013;2013: Gaetani* et al. Percutaneous arthrodesis of sacro-iliac joint: a pilot study. J Neurosurg Sci Dec;57(4): *Paid consultant of SI-BONE, Inc.; Conducts clinical research for SI-BONE Inc.; Ownership interest in SI-BONE Inc.; ±Recipient of an SI-BONE research grant. 37

38 Satisfaction & Quality of Life Patient Satisfaction QOL Improvement from Baseline 82% 100% 95% 100% 85% SF 12 PCS Cummings mo p<0.005 SF 36 PCS Duhon mo p=0.003 EQ 5D Duhon mo P= Rudolf 2012 (avg 40mo) Sachs 2013 (12mo) Cummings 2013 (12mo) Gaetani 2013 (8 18mo) Duhon 2013 (6mo) RDQ Gaetani mo p<0.01 *Disclosures: Rudolf Paid consultant of, ownership interest in, and conducts clinical research for SI BONE Inc. Sachs Paid consultant of and conducts clinical research for SI BONE Inc. Cummings Paid consultant of and conducts clinical research for SI BONE Inc. Gaetani Conducts clinical research for SI BONE Inc. Duhon Paid consultant of and conducts clinical research for SI BONE Inc. SF 12 PCS = Short Form 12 patient questionnaire, Physical Component Summary SF 36 PCS = Short Form 36 patient questionnaire, Physical Component Summary EQ 5D = EuroQOL 5 Dimension questionnaire RDQ = Roland Morris Questionnaire 38

39 Perioperative Measures & Complaints Operative Process Measures Significantly Less in MIS Compared to Open Surgery 1 Low Complaint and Revision Rates Less estimated blood loss (EBL) Shorter OR Time Shorter Length of Stay (LOS) < 5% overall complaint rate (as of Feb 2014) 2 Miller Med Device Evid Res patients (~16,000 implants) in the US and Europe from Apr 2009-Jan 2013, performed by 487 different surgeons. 3.8% overall complaint rate 1.8% revision rate 1. Graham Smith* Ann Surg Innov 2013 (*Paid consultant of SI BONE, Inc.) 2. Complaint Handling Database (SI BONE, Inc. Data on file.) 3. Miller LE, et al. Medical Devices: Evidence and Research

40 Indications & Risk Statement Indications: The ifuse Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. Risk Statement: As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the ifuse Implant. Contraindications, warnings, precautions, risks, and alternative treatments should be discussed with the patient. 40

41 Summary Prevalence 15 to 30% of all LBP Diagnosis Battery of tests and SI joint injection Treatment options: Conservative care: 1. Physical Therapy/ Bracing 2. SI joint injections 3. RF Ablations MIS SI Joint Fusion: 1. ifuse Implant System 41