Kasper W Janssen, Willem Van Mechelen and Evert A L M Verhagen
Bracing superior to neuromuscular training for the prevention of self-reported recurrent ankle sprains: a three-arm randomised controlled trial
In cooperation with;
This article are associated with 1. Department of Public and Occupational Health, EMGO institute for Health and Care Research, VU University Medical center, Amsterdam. 2. Department of Sports and Exercise Medicine.
The authors of this randomized clinical trial compared the effectiveness of 3 interventions
- 8 week home-based neuromuscular training programme (N=120)
- Semirigid ankle brace worn during sports activities for 12 mounths (N=126)
- Combination group received the 8 weeks home-based neuromuscular training programme and a semirigid ankle brace worn during sports activities for 8 weeks (N=138).
384 athletes, aged 18-70, who had a sustained lateral ankle sprain.
The authors also reported that there were compliance issues within each group (full compliance:
- 45% training,
- 23% bracing,
- 28% combination)
as well as participants who reported adding either a brace or training to their assigned intervention program (~15% of participants).
69 (20%) participants reported a recurrent ankle sprain.
29 (27%) in the training group. (2,5 sprains / 1000h of sport)
17 (15%) in the brace group. (0.5 sprains / 1000h of sport)
23 (19%) in the combi group. (0.7 sprains / 1000h of sport)
The relative risk for a recurrent ankle sprain in the brace group vs. the training group was 0.53 (95% CI 0.29 to 0.97). No significant difference in were found for time loss or cost due to ankle sprain between interventions.
On the follow up after 12 months, the incidence of ankle sprain per 1000 hours of sports activity was 1.34 with a 95% CI (0,70-1.98) in the brace ground, in combination group it was 1.78 (95% CI (1,05-2.51)) and in the control group (NMT) it was 2.51 (95% CI (1.,51-3.42)
This means that the brace group had a significant lower risk (47%) of a recurrent ankle sprain compared with the training group (RR 0.53, 95% CI 0,29-097). The combi group also had a lower risk estimated 29% than the training group, through not statistically significant (RR 0.71, 95% CI 0.41-1.23) (janssen et al. 2014)
Bracing was superior to neuromuscular training in reducing the incidence but not the severity of self-reported recurrent ankle sprain after usual care.
It may have been interesting to look at this as well as patient reported reasons for non-compliance. Also, the prescribed training program was only 2 months in duration, while the bracing was for 12 months. A 2 month training program is typical following an ankle sprain; however, perhaps we should consider the value of a longer-term training program for prevention.
Also, despite a lack of significant findings, the combination training/brace group had lower ankle sprain recurrence than the training only group, comparable to the brace for 12 months group.
Clinically, it appears that bracing is the best option post-ankle sprain to reduce the risk of recurrent sprains.
The neuromuscular training was considered as best practise.
1. eligibility criteria were specified. (X YES / NO)
Participants were recruited from April 2010 to June 2011 through non-medical channels; that is, through advertisements on the Internet and via mailings of Dutch sports federations. For eligibility, participants had to
- have sustained a lateral ankle sprain no more than 2 months prior to inclusion;
- have an age between 18 and 70 years and
- be actively participating in sports for at least 1 h/week.
Before inclusion, an oral assessment of the reported ankle sprain was conducted by a sports physician to confirm eligibility. The form included registration of diagnosis, cause and aetiology of the reported ankle sprain. Furthermore, treatment and type of practitioner were recorded. All primary treatment options were allowed, that is, no treatment, self-treatment or (para-)medical treatment.
Potential participants were excluded if they
- had insufficient mastery of the Dutch language;
- had a history of vestibular problems or
- were suspected to have sustained a different injury than an ankle sprain after interview by telephone.
2. subjects were randomly allocated to groups (in order in which treatments were received) (X YES / NO)
“When the baseline questionnaire and the informed consent were received, participants were randomly assigned to one of the three intervention groups. Randomisation was stratified for care received (ie, medical vs non-medical primary care).
3. allocation was concealed (YES / NO)
Allocation of the participants to the intervention groups was concealed by application of participant numbers. Only after the participants had completed the baseline questionnaire and had provided written informed consent, they were assigned a participant number. A blinded research assistant allocated the participant numbers to one of the three intervention groups by using a random numbers table.”
4. the groups were similar at baseline regarding the most important prognostic indicators (YES / NO X)
Participants allocated to the neuromuscular training (training group) group received an 8-weeks home based neuromuscular training programme. This programme has been previously evaluated and is linked to 35% reduction in ankle spring recurrence risk. The programme involves three session pr. week with a max duration of 30min/session.
Participant allocated to the brace group (bracing group) received a semi-regid ankle brace to be worn dural all activities for the duration of the entire 12 months follow up.
Participant allocated to the combination group (combi) received the 8-weeks neuromuscular programme as well as the ankle brace. Participants in this group was instructed to wear the ankle brace during all sporting activities during the 8-week neuromuscular training period.
5. there was blinding of all subjects (YES X/ NO)
A blinded research assistant allocated the participant numbers to one of the three intervention groups by using a random number table.
6. There was blinding of all therapists who administered the therapy
(YES X/ NO)
The participant had to fill out a questionaire if the got a recurrence injury. Misclassification of injuries was minimised by verification of the diagnose on the basis of the injury registation form by a sports physcian, blinded for the allocated intervention. In case of doubt regarding a recurrent ankle sprain, a more specific diagnosis was made question
7. there was blinding of all assessors who measured at least one key outcome (YES / NO)
The study used a simple random number generator for the randomisation scheme, in two strata, groups were not evenly distributed.
8. measures of at least one key outcome were obtained from more than 85% of the subjects initially allocated to groups
The overall compliance in the training group was 45%, which implies that neuromuscular training is currently more widely accepted as a secondary preventive measure. The compiance in the combi group were 28%, whereas the brace group had 48% compliance (dropping to 44% after 3 months of follow-up).
9. all subjects for whom outcome measures were available received the treatment or control condition as allocated or, where this was not the case, data for at least one key outcome was analysed by “intention to treat”
10. the results of between-group statistical comparisons are reported for at least one key outcome
11. the study provides both point measures and measures of variability for at least one key outcome