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Treatment of acute ankle sprains in general practice


- candidate number19386
- NTR NumberNTR4765
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-sep-2014
- Secondary IDsMEC-2014-250  80-83910-98-13003
- Public TitleTreatment of acute ankle sprains in general practice
- Scientific TitleTreatment of acute ankle sprains in general practice
- ACRONYMtrAPP-study
- hypothesisAn unsupervised e-health supported neuromuscular training program, in addition to usual care in general practice, is more effective compared to usual care alone as a treatment for patients with acute lateral ankle sprains in general practice.
- Healt Condition(s) or Problem(s) studiedAcute ankle sprain
- Inclusion criteriaPatients with an acute lateral ankle sprain are eligible for this study if they are aged between 14 and 65 years, visit the general practitioner within two weeks of injury and sign an informed consent.
- Exclusion criteriaPatients are excluded if: they have a history of an injury of the same ankle during the previous two years; they have had a fracture of the same ankle; they have no understanding of Dutch language.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate1-jan-2019
- Target number of participants169
- InterventionsGroup 1. The neuromuscular training program: Subjects allocated to the intervention group receive a standardized eight-week neuromuscular training program, based on the training program described by Hupperets et al. (2008), in addition to usual care (information leaflet).
- Primary outcomeThe total number of re-sprains reported after 1-year follow-up.
- Secondary outcomea) Subjective recovery after 1-year follow-up, on a 7-point Likert scale. Patients are deemed to be recovered if they rate themselves as “fully recovered” or “strongly recovered”.
b) Pain at rest and during activity (11 point-NRS)
c) Function (Ankle Function Score)
d) Return to sport
e) Cost-effectiveness of the intervention
f) Compliance of the intervention (completed at least 75% of the training sessions)
- TimepointsOnline questionnaires will be administered monthly: at baseline, after 4, 8, 12, 16, 21, 26, 31, 35, 39, 43, 47, and 52 weeks follow-up.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. M. Middelkoop, van
- CONTACT for SCIENTIFIC QUERIESDr. M. Middelkoop, van
- Sponsor/Initiator Erasmus Medical Center, Department of General Practice
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsNA
- Brief summaryRationale: Ankle sprains are the most frequent traumas of the musculoskeletal system, with yearly around 650.000 new sprains in the Netherlands. Of these, about 130.000 people will visit the general practitioner (GP) each year. The Dutch NHG-guideline summarizes the evidence on the potential treatments for acute ankle sprains; however there is very little guidance for treatment. No optimal treatment modality has proven to be effective in general practice.
Objective: To examine the 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 lateral ankle sprains in general practice.
Study design: Randomized Controlled Trial (RCT)
Study population: Patients with an acute lateral ankle sprain, aged between 14 and 65 years, and visiting the general practitioner within three weeks of injury.
Intervention: 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.
Main study parameters/endpoints: The total number of re-sprains reported after 1-year follow-up.
- Main changes (audit trail)6-dec-2014: Inclusion criterium changed, new criterium: Patients with an acute lateral ankle sprain are eligible for this study if they are aged between 14 and 65 years, visit the general practitioner within three weeks of injury and sign an informed consent.
- AB

5-mrt-2017: New inclusion criterium: Patients are excluded if: they have a history of an injury of the same ankle during the previous year; they have had a fracture of the same ankle; they have no understanding of Dutch language.
- RECORD2-sep-2014 - 5-mrt-2017


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