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Clinical effectiveness of customised sport shoe orthoses for overuse injuries in runners– a randomised controlled study
  1. Anja Hirschmüller1,*,
  2. Heiner Baur2,
  3. Steffen Müller2,
  4. Peter Helwig1,
  5. Hans-Hermann Dickhuth3,
  6. Frank Mayer2
  1. 1 Albert-Ludwigs University Freiburg, Department Orthopaedics and Traumatlogy, Germany;
  2. 2 University of Potsdam, Department of Sports Medicine and Prevention, Germany;
  3. 3 Albert-Ludwigs University Freiburg, Department of Rehabilitative and Preventive Sports Medicine, Germany
  1. Correspondence to: Anja Hirschmüller, Orthopaedic Surgery and Traumatology, Uniklinik Freiburg, Hugstetterstrasse 55, Freiburg, 79106, Germany; anja.hirschmueller{at}


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 subject’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, semi-rigid 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 rating scale (SES), the pain disability index (PDI) and a comfort index in the orthoses group (ICI).

Results: There were statistically significant differences between orthoses and control group at 8 weeks for PDI (mean difference 3.2 (95% CI 0.9 to 5.5) and SES (6.6 (2.6 to 10.6)). The orthoses patients reported a rising wearing comfort (ICI pre 69/100, ICI post 83/100) which was most pronounced in the first four 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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