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.