What we do
About our project
Background
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.
Hypothesis
We hypothesize that unsupervised neuromuscular training program in combination with usual care is more effective in the reduction of re-sprains, compared to usual care alone, after a 52 week period.
Methods
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.
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.
Hypothesis
We hypothesize that unsupervised neuromuscular training program in combination with usual care is more effective in the reduction of re-sprains, compared to usual care alone, after a 52 week period.
Methods
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.
Our research focus
Primary outcome
The primary outcome is the number of re-sprains reported after 1-year follow-up.
Secondary outcomes
a) Subjective recovery after 1-year follow-up
b) Pain at rest and during activity
c) Function
d) Return to sport
e) Cost-effectiveness of the intervention
f) Compliance of the intervention
The primary outcome is the number of re-sprains reported after 1-year follow-up.
Secondary outcomes
a) Subjective recovery after 1-year follow-up
b) Pain at rest and during activity
c) Function
d) Return to sport
e) Cost-effectiveness of the intervention
f) Compliance of the intervention
Funds & Grants
ZonMw HGOG (839110002)
Collaborations
Department of Helath Sciences and EMGO Institute for Health and Care Research
VU University Medical Center Amterdam, The Netherlands
VU University Medical Center Amterdam, The Netherlands
Publications
1. Mailuhu AK, Verhagen EA, van Ochten JM, Bindels PJ, Bierma-Zeinstra SM, van Middelkoop M. 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. BMC Musculoskelet Disord. 2015 Apr 9;16:78. doi: 10.1186/s12891-015-0539-9.
2. Subgroup characteristics of patients with chronic ankle instability in
primary care. Mailuhu AKE, et al. J Sci Med Sport 2019. PubMed PMID: 30878293.
3. Clinical and radiological predictors for persistent complaints five years after a lateral ankle sprain: A long-term follow-up study in primary care Mailuhu AKE, et al. J Sci Med Sport 2018 - Clinical Trial. PubMed PMID: 28780197.
2. Subgroup characteristics of patients with chronic ankle instability in
primary care. Mailuhu AKE, et al. J Sci Med Sport 2019. PubMed PMID: 30878293.
3. Clinical and radiological predictors for persistent complaints five years after a lateral ankle sprain: A long-term follow-up study in primary care Mailuhu AKE, et al. J Sci Med Sport 2018 - Clinical Trial. PubMed PMID: 28780197.
Our team
A.K.E. Mailuhu (PhD student), a.mailuhu@erasmusmc.nl
Dr. M. van Middelkoop (co-promotor), m.vanmiddelkoop@erasmusmc.nl
Prof. Dr. E.A. Verhagen, e.verhagen@vumc.nl
Dr. J. van Ochten, j.vanochten@erasmusmc.nl
Prof. Dr. P.J.E. Bindels, p.bindels@erasmusmc.nl
Prof. S.M.A. Bierma-Zeinstra (promotor), s.bierma-zeinstra@erasmusmc.nl
Dr. M. van Middelkoop (co-promotor), m.vanmiddelkoop@erasmusmc.nl
Prof. Dr. E.A. Verhagen, e.verhagen@vumc.nl
Dr. J. van Ochten, j.vanochten@erasmusmc.nl
Prof. Dr. P.J.E. Bindels, p.bindels@erasmusmc.nl
Prof. S.M.A. Bierma-Zeinstra (promotor), s.bierma-zeinstra@erasmusmc.nl
