The authors declare that they have no competing interests.
All authors made substantive intellectual contributions to the development of the study protocol and contributed to the content of the article. AKEM participated in the design and the coordination of the study and wrote the medical ethical approval application and the article, which is based on the funding application written by MM. The trial is coordinated by MM. All authors read and approved the final manuscript.
Ankle sprains are one of the most frequent injuries of the musculoskeletal system, with yearly around 680.000 new sprains in the Netherlands. Of these, about 130.000 people will visit the general practitioner (GP) each year. In addition, patients have an increased risk of a recurrent ankle sprain and about a third report at least one re-sprain. No optimal treatment strategy has proven to be effective in general practice, however promising results were achieved in a preventive trial among athletes. Therefore, the objective is to examine the (cost)-effectiveness of an unsupervised e-health supported neuromuscular training program in combination with usual care in general practice compared to usual care alone in patients with acute ankle sprains in general practice.
This study is a multi-center, open-label randomized controlled trial, with a one-year follow-up. Patients with an acute lateral ankle sprain, aged between 14 and 65 years and visiting the GP within three weeks of injury are eligible for inclusion. Patients will be randomized in two study groups. The intervention group will receive, in addition to usual care, a standardized eight-week neuromuscular training program guided by an App. The control group will receive usual care in general practice alone. The primary outcome of this study is the total number of ankle sprain recurrences reported during one year follow-up. Secondary outcomes are subjective recovery after one year follow-up, pain at rest and during activity, function, return to sport, cost-effectiveness and compliance of the intervention. Measurements will take place monthly for the study period of 12 months after baseline measurement.
For general practitioners the treatment of acute ankle sprains is a challenge. A neuromuscular training program that has proven to be effective for athletes might be a direct treatment tool for acute ankle sprains in general practice. Positive results of this randomized controlled trial can lead to changes in practice guidelines for general practitioners. In addition, since this training program is e-health supported, positive results can also lead to a novel way of injury prevention.
Dutch Trial Registration: NTR4765.
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- The trAPP-study: cost-effectiveness of an unsupervised e-health supported neuromuscular training program for the treatment of acute ankle sprains in general practice: design of a randomized controlled trial
Adinda KE Mailuhu
Evert ALM Verhagen
John M van Ochten
Patrick JE Bindels
Sita MA Bierma-Zeinstra
Marienke van Middelkoop
- BioMed Central
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