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| Clinical effectiveness of customised sport shoe orthoses for overuse injuries in runners: a randomised controlled study [with consumer summary] |
| Hirschmuller A, Baur H, Muller S, Helwig P, Dickhuth HH, Mayer F |
| British Journal of Sports Medicine 2011 Sep;45(12):959-965 |
| clinical trial |
| 5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; 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 score has been confirmed* |
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BACKGROUND AND OBJECTIVES: Treatment of chronic running-related overuse injuries by orthopaedic shoe orthoses is very common but not evidence-based to date. Hypothesis Polyurethane foam orthoses adapted to a participant's barefoot plantar pressure distribution are an effective treatment option for chronic overuse injuries in runners. DESIGN: Prospective, randomised, controlled clinical trial. Intervention 51 patients with running injuries were treated with custom-made, semirigid running shoe orthoses for 8 weeks. 48 served as a randomised control group that continued regular training activity without any treatment. MAIN OUTCOME MEASURES: Evaluation was made by the validated pain questionnaire Subjective Pain Experience Scale, the pain disability index and a comfort index in the orthoses group (ICI). RESULTS: There were statistically significant differences between the orthoses and control groups at 8 weeks for the pain disability index (mean difference 3.2; 95% CI 0.9 to 5.5) and the Subjective Pain Experience Scale (6.6; 2.6 to 10.6). The patients with orthoses reported a rising wearing comfort (pre-treatment ICI 69/100; post-treatment ICI 83/100) that was most pronounced in the first 4 weeks (ICI 80.4/100). CONCLUSION: Customised polyurethane running shoe orthoses are an effective conservative therapy strategy for chronic running injuries with high comfort and acceptance of injured runners.
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