Heel Steroid Injection

Transcription

1 Heel Steroid Injection Evidence of effectiveness 2 systematic reviews (2 included) ~/ ~ 2 experimental studies (2 included) ~/ -/~ 1 observational (1 included) 2.5/3 Evidence of safety and harm Generic legend: - t applicable - t stated n/r - t relevant? - unsure or unclear 1

2 Systematic Reviews authors and year design Crawford, F. and C. Thomson (2003). Interventions for treating plantar heel pain.[update of Cochrane Database Syst Rev. 2000;(3):CD000416; PMID: ]. Cochrane Database of Systematic Reviews.(3) Systematic review inclusion & exclusion criteria To test 2 hypotheses: A. there is difference in patient outcomes between those individuals with plantar heel pain who receive therapeutic intervention and those who do t. B. There is difference in patient outcomes between different therapeutic intervention for plantar heel pain. RCTs evaluating patients for heel pain arising from fracture, tumours, surgery or posterior pain involving the tendon. Achilles, peroneus longus Adults Any age group exposure / treatment (number of studies included) Studies re steroid injections Black 1996 Blockey 1956 *Crawford 1999 Kriss 1990 Lynmch 1998 Gudeman 1997 Included studies N=NR Retrieved N=25 Eligible N=19 Steroid studies N=5 Iontophoresis with and without steroid injection N=1 Overall population size N=238 patients common outcomes among studies Endpoints Pain measured on VAS was the primary outcome in all but one trial where patients perception of pain was measured. Exposure Steroid injections (4 different preparations reported) Comparison Orthosis, anaesthetic, placebo, heel cup, never block FU 3-18 mo results validity / applicability Overall effect p-value Weighted mean diff (fixed effects) Pain VAS Hydrocortisone vs saline b a ( ) Steroid injection vs orthosis 6.25? < (59.12 to-30.90) Steroidorthosis vs steroid ?( ) Steroidorthosis vs orthosis ( ) Steroid vs local anaes. (1 mo) (-3.06 to 0.82) Steroid vs local anaes. (3 mo) ( ) Steroid vs heel cup ( ) Steroid vs steroidnerve block ( ) Figures in bold=significant effect favouring steroid injection Note: one evaluating iontophoresis and dexamethasone with iontophoresis and saline injection showed an improvement in the outcomes of the group that included the steroid injection at 2-3 weeks but after 4 weeks there was significant difference between the groups. Adverse events: t reported in 4 out of 5 trials, in the remaining trial it was reported that there were AEs in either group. a = RR risk b patient s perception of pain focussed question thorough search strategy search terms defined appropriate inclusion / exclusion criteria two reviewers selection validity rated two reviewers validity valid combination of studies appropriate analysis all important outcomes balance between benefits and harms fair conclusions from evidence? conclusions, comments Validity: Precision: ~ to ~/ Applicability: ~/ Overall quality: ~/ There is limited evidence upon which to base clinical practice. Steroid injections are a popular method of treatment but only seem to be useful in the short term and only to a small degree. Tibial nerve block with steroid injection does t appear to confer any additional comfort during the procedure. It is difficult to judge the size of the effect and there is guidance given. The reported small degree of relief does t seem to be consistent with some of the reported data. *Included in this review 2

3 authors and year design inclusion & exclusion criteria exposure / treatment (number of studies included) common outcomes among studies results validity / applicability conclusions, comments McLauchlan, G. J. and H. H. G. Handoll (2002). Interventions for treating acute and chronic Achilles tendinitis. Cochrane Database of Systematic Reviews: 4. Systematic Review (Cochrane Review) Systematic search Dec 2000 medline, embase, Cochrane controlled trials register, cinahl. No language restrictions To assess the effectiveness of various treatment interventions for acute and chronic Achilles tendonitis in adults. RCTs and quasi RCTs Trials with <5 pts in each arm with Achilles tendinitis Trials with mixed populations for which separate data could t be obtained. Exposure Methylprednisolone Anaesthetic physio Comparison Anaesthetic physio Studies *Da Cruz 1988 peri-tendonitis injection of steroid vs. placebo *Included in this review Return to pre-injury activity level Recurrent injury Pain complications 12 weeks Only one trial included in the review examined the effect of steroid injections DaCruz 1988 Effectiveness and safety reported in a separate ET Methodological quality score = 12/20 (60%) No overall effect, RR or weighted mean differences reported in this SR for the trial because unit of analysis problems and insufficient data. Safety No adverse events reported focussed question thorough search strategy search terms defined appropriate inclusion / exclusion criteria two reviewers selection validity rated two reviewers validity valid combination of studies appropriate analysis all important outcomes balance between benefits and harms fair conclusions from evidence * No adverse events reported? * Validity: ~/ Precision: NR Applicability: ~/ Overall quality: ~ Crossover nature of the trial hampered the interpretation of the results. In general the SR concluded that there was insufficient evidence from RCTs to determine which method of treatment was the most appropriate for the treatment of chronic or acute Achilles tendinitis. Limited reporting of the one there review quality difficult to assess 3

4 Experimental Studies authors and year design participants inclusion/ exclusion exposure/ outcomes results validity / applicability conclusions, comments, Crawford, F., Atkins, D., Young, P., & Edwards, J. (1999). Steroid injection for heel pain: evidence of short-term effectiveness. A randomized controlled trial. Rheumatology., 38(10), RCT Blind assessor To compare the effectiveness of a steroid injection of 25 mg/ml prednisolone acetate with a local anaesthetic control in the treatment of heel pain and to determine any advantage for patient s comfort of using a posterior tibial nerve block to anaesthetize the heel prior to infiltration. Age: 57 yr(30-87 yrs) Male: 37 Female: 69 Median duration 6 mo (1=120 months) N=NR N=106 Completed N=55 Clinical diagsis of heel pain and reporting pain and tenderness cantered on the medial tubercle of the calcaneum on weight bearing after rest which resolved partially or fully after activity. Patients under the age of 18 yrs, pregnant females, steroid injection for heel pain in the previous 6 months, anticoagulant therapy, inability to give consent. 4 treatment groups Group 1 (GR1) 1 ml of 25 mg/ml prednisolone acetate with 1 ml of 2% ligcaine. Group 2 (GR2) 1 ml of 25 mg/ml prednisolone acetate with 1 ml of 2% ligcaine given after tibial nerve block Group 3 (GR3) 2 ml of 1% ligcaine hydrochloride Group 4 (GR4) 2 ml of 1% ligcaine hydrochloride given after tibial nerve block 6 mo FU VAS mean pain score at 1, 3 and 6 months GR1 GR2 GR3 GR4 (n=27) (n=26) (n=27) (n=26) Pain VAS mean pain score at FU (bold = significantly different from baseline score) Evaluation at 1 month 4.0(2.9) 4.5(2.6) 2.9(2.5) 5.3(2.9) Evaluation at 3 months 3.7(3.3) 3.4(2.7) 3.6(2.8) 3.1(2.7) Evaluation at 6 months 3.3(2.7) 2.5(3.2) 2.4(2.6) 0.6(1.1) Evaluation at 1 month showed a statistically significant pain reduction difference in favour of Gr1 (steroid) p=0.02, differences at 3 and 6 months were t statistically significant (p=0.9 and p=0.8). Progstic variables There was statistically significant relationship between pain reduction and of condition Tibial nerve block Heel anaesthetisation BMI Occupation Age Helbing s sign Insole wearing Safety and adverse events Not reported Note: at six months the patients that did document pain (52%) were uniform across groups in relation to pain reduction. Method described Similar at baseline Concealment Intention to treat Blinding appropriate Single blind Blind outcome assessment Compliance OK Follow-up OK Drop outs<20% Generalisability Feasible/Affordable All important outcomes Balance between benefits and harms? / Validity: ~/ Precision: Applicability: ~ Overall quality: ~/ A steroid injection can provide relief from heel pain in the short term. There appears to be increase in patient comfort from anaesthetising the heel prior to infiltration. The trial was t powered to detect clinically significant differences at months and 6 months because of high drop out rates. It is t clear is significant testing was between or within groups. No adverse event reporting. A well designed flawed by underpowering at 3-6 -months and lack of side effects reporting. 4

5 authors and year design participants inclusion/ exclusion exposure/ outcomes results validity / applicability conclusions, comments, DaCruz, D. J., M. Geeson, et al. (1988). Achilles paratendonitis: an evaluation of steroid injection. British Journal of Sports Medicine. 22(2): RCT Prospective Consecutive Crossover (for n responders) To evaluate the role of peritendous injection of methyl prednisolone in patients presenting to A&E with Achilles paratendonitis. Average Age: 28 years (22-46) Male: 18 Female: 10 21% had bilateral problems. N=NR N=36 Evaluable N=28 Completed N=28 All patients presenting to A&E with pain and tenderness in the Achilles tendon, gradual in onset and t accompanied by signs of a complete or partial tear of the tendon, previous therapy for the condition and systemic steroid therapy. Pain at the musculotendous junction, pain at the point of insertion of the Achilles tendon. Exposure (st) Local peri-tendous injection of 40 mg methyl prednisolone acetate 1 ml of marcaine 0.25% physiotherapy twice weekly for 4 weeks including ice packs, ultrasound (US) therapy, orthopaedic felt heel insert. Comparison (ctrl) Local peri-tendous injection of 2 ml of marcaine 0.25% physiotherapy twice weekly for 4 weeks including ice packs, US therapy, orthopaedic felt heel insert. Note: marcaine is a long acting anaesthetic? 12 weeks for each therapy group Pain score improvement from baseline at 6 and 12 weeks St (n=19) Ctrl(n=15) 6 week assessment ( measured from baseline) Fully recovered tendons (%) 32% 33% Pain score improvement from baseline 6 8 Tenderness grade I a (% remaining pts) 46% 50% Tenderness grade II a (% remaining pts) 38% 20% Tenderness grade III a (% remaining pts) 15% 20% Activity level 50-75% (% remaining pts) 77% 70% 12 week assessment (measured from baseline) Pain score improvement from baseline (LAS) Tenderness grade I a (% remaining pts) 46% 40% Tenderness grade II a (% remaining pts) 46% 30% Tenderness grade III a (% remaining pts) 8% 30% Activity level 50-75% (% remaining pts) 77% 70% Responders: 11/34 (32%), when patients did respond they did so within 6 weeks Non-responders: 23/34 (68%) failed to respond to therapy at all despite crossing over to the alternative therapy at 12 weeks (refractory disease). 11/23 (48%) subsequently underwent surgery with excellent results 12/23 (52%) elected t to have further treatment. a Grade 1= lowest degree of tenderness, Grade III= highest degree of tenderness Adverse events t reported Method described Similar at baseline Concealment Intention to treat Blinding appropriate Single blind Blind outcome assessment Compliance OK Follow-up OK Drop outs<20% Generalisability Feasible/Affordable All important outcomes Balance between benefits and harms? / Validity: ~ Precision: - Applicability: ~ Overall quality: -/~ Locally acting steroid injections have role to play. Patients who did respond to treatment had only minimal signs and symptoms when they presented and recovered within six weeks. The first assessment at 6 weeks may have been too long to observe any short term effects of the steroid injection. The results are difficult to interpret both groups had physiotherapy, US therapy and Ice pack, both had long acting anaesthetic and there was 2 or 4 week assessment. There was subgroup analysis based on severity of presenting symptoms. It was a crossover, and the units of analysis were t clear. Patients who had fully recovered were t included in the results table. 6 patients appear to have had bilateral treatment i.e. 12/34 (35%) tendons but it is t clear if they were evenly distributed between the two groups. Responders all exhibited grade I tenderness (lowest) and had activity levels of 50% at presentation. 5

6 Observational Studies authors and year design participants inclusion/ exclusion exposure/ outcomes results conclusions, comments, and quality scores Acevedo JI, Beskin JL. Complications of plantar fascia rupture associated with corticosteroid injection. Foot & Ankle International. 1998;19(2):91-7. Case Series Safety analysis To define complications in patients with plantar fascia rupture after corticosteroid injection. Age: 51 years Male:18 Female: 25 N=51/765 Enrolled N=43 pts, 44 ruptures. Evaluable N=39 Patients with a clinical diagsis of plantar fasciitis rupture Not reported Exposure Corticosteroid injection 1 to 5 injections FU Mean 26.8 months (12-44) Chart analysis and telephone survey. Recovery rated excellent ( points), good (80-89 points), fair (70-79 points), poor (<70 points) Between , 51/765 patients with plantar fasciitis were diagsed with plantar facia rupture. 43/51 (84%) had received 1 or more corticosteroid injections. No. injections No. patients Mean 2.1 Mean time to rupture after injection 10.4 weeks ( 2-24) Symptom development Thirty patients (68%) reported a sudden onset of tearing at the heel, and 14 (32%) had a gradual onset of symptoms. In most cases the original heel pain was relieved by rupture but patients subsequently developed new problems including longitudinal arch strain/pain lateral and dorsal midfoot strain/pain lateral plantar nerve dysfunction stress fracture hammertoe deformity swelling and/orantalgia Case series score: 2.5/3 Our findings demonstrate that plantar fascia rupture after corticosteroid injection may result in long-term sequelae that are difficult to resolve. Little information about the corticosteroid used and dosage. Some confusing information relating to the authors series and the reported series. Limited detail about the number of patients presenting with specific new complications after rupture Progsis Treatment including NSAIDs, rest or cross training, stretching, orthotics, and boot-brace immobilization resulted in excellent/good results in 50% of patients and fair/poor scores in 50% at an average FU of 27 months. 26 feet remained symptomatic 1 year post rupture. 6