Clinical effectiveness of customised sport shoe orthoses for overuse injuries in runners: a randomised controlled study

Br J Sports Med. 2011 Sep;45(12):959-65. doi: 10.1136/bjsm.2008.055830. Epub 2009 Aug 12.


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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Activities of Daily Living
  • Adult
  • Chronic Disease
  • Cumulative Trauma Disorders / therapy*
  • Disability Evaluation
  • Disabled Persons
  • Equipment Design
  • Female
  • Humans
  • Male
  • Middle Aged
  • Musculoskeletal Pain / etiology
  • Musculoskeletal Pain / prevention & control
  • Orthotic Devices*
  • Pain Measurement
  • Patient Satisfaction
  • Polyurethanes / therapeutic use
  • Prospective Studies
  • Running / injuries*
  • Shoes*
  • Treatment Outcome
  • Young Adult


  • Polyurethanes
  • polyurethane foam