Effectiveness of treatment with brace versus tape in acute lateral ankle sprains

ISRCTN	ISRCTN92030205
DOI	https://doi.org/10.1186/ISRCTN92030205
Protocol serial number	N/A
Sponsor	University Medical Center Utrect (Netherlands)
Funders	NEA International [manufacturer of Push Brace] (Netherlands), University Medical Centre Utrecht (Netherlands)

Submission date: 12/10/2011
Registration date: 03/01/2012
Last edited: 17/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Ankle sprains are the most frequently reported sports injuries often leading to pain and other impairments including chronic physical limitations and impingement. Another frequently regularly reported problem is the recurrence of an ankle sprain. The risk of re-spraining within a period of 3 years after the initial ankle sprain was reported to range from 3 to 34%. Since the 1990s, functional treatment of ankle sprains is highly recommended. Nowadays, the regular treatment of an ankle sprain includes ankle taping, while the use of an ankle brace is conventional to prevent re-injuries is conventional.
The purpose of this study is to investigate the effect of a 4-week treatment with an ankle brace (soft brace) compared to the treatment with an ankle tape on recurrent sprain and residual problems within one year in patients with an acute lateral ankle sprain.

Who can participate?
If you are aged over 18 and diagnosed with an acute lateral ankle sprain caused by an inversion trauma, you can participate in this study.

What does the study involve?
When you decide to participate in this study you are treated with an ankle brace or ankle tape for four weeks. A sports physician conducts the initial measurements (baseline) consisting of an anamnesis and a physical exam during which the ankle is examined for swelling, discoloration by hematoma, limited dorsiflexion and tenderness at baseline. Several tests are performed to measure passive and active ankle stability. After the baseline measurements, at week 5, 9, 13, 26 and 39 post-trauma, you have to fill in online questionnaires asking about re-injuries and residual complaints. After 52 weeks a final assessment by a sports physician takes place.

What are the possible benefits and risks of participating?
Ankle brace treatment and ankle tape treatment can result in skin irritations or dermatitis. If you are familiar with this hyper sensitiveness of the skin, preventive measures can be taken in advance.

Where is the study run from?
The study was organised by the Department of Revalidation, Nursing Science and Sport of the University Medical Centre Utrecht (Netherlands). Twenty GPs, nine physiotherapy practices and two emergency departments in the region of Utrecht recruited patients for this study.

When is the study starting en how long is it expected to run for?
The study was open for patients between May 2006 and October 2009. Follow-up examinations continued until one year after inclusion. The total data collection ended in November 2010.

Who is funding the study?
This study was funded by NEA International, manufacturer of the ankle brace type Push med Ankle Brace.

Who is the main contact?
Mrs Ingrid van de Port, PhD (senior researcher)
iport@umcutrecht.nl

Contact information

Prof Frank Backx
Scientific

Rudolf Magnus Institute of Neuroscience
Department of Rehabilitation
Nursing Science and Sport
University Medical Centre Utrecht
F00.810
PO Box 85500
Utrecht
3508 GA
Netherlands

Email	fbackx@umcutrecht.nl

Study information

Primary study design	Interventional
Study design	Multi-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effectiveness of a 4 week treatment with ankle brace versus ankle tape on recurrent sprain and residual problems within one year in patients with acute lateral ankle sprains
Study objectives	The treatment of acute lateral ankle sprains with an ankle brace is more effective than the treatment with ankle tape
Ethics approval(s)	University Medical Centre Utrecht Ethics Committee, 29/11/2005, ref: 05/153
Health condition(s) or problem(s) studied	Acute lateral ankle sprain
Intervention	The intervention group received instructions from the sports physician about how to use and fix the Push Med ankle brace, which is a soft brace and based on the principle of the functional tape bandage. The patients were instructed to wear the ankle brace for four weeks, except when taking a shower. The control group received ankle tape for four weeks. The tape bandage was applied by the GP, assistant, physiotherapist or the plaster technician. The tape technique was applied as usual. A new tape was provided at a maximum of two weeks after the first application by one of the mentioned persons.
Intervention type	Other
Primary outcome measure(s)	Risk for re-injury based on the amount of patients reporting re-injuries within one year
Key secondary outcome measure(s)	1. Residual symptoms (objective and subjective) 1.1. The objective residual symptoms were swelling (yes/no), functional outcome, passive and active stability 1.2. The subjective residual symptom was pain 2. Dorsiflexion of the ankles was measured to determined functional outcome. Patients could have limited dorsiflexion in the injured ankle compared to the healthy ankle, no limitation in dorsiflexion, or better dorsiflexion than the healthy ankle. 3. Passive stability was measured with dynamic anterior ankle tester. The passive stability of both ankles could be equal, the passive stability of the injured ankle could be worse than the healthy ankle, or the passive stability of the healthy ankle could be worse than the injured ankle. 4. Four one leg stance tests with increasing difficulty with increasing difficulty were applied to measure active stability. The first one leg stance test was conducted with eyes open, the second with eyes closed, the third with eyes closed and knee in 45 degrees dorsiflexion, and the last, and most difficult, with eyes closed, knee in 45 degrees dorsiflexion and standing on the forefoot. Both legs were tested. Being able to stand on one leg for 15 seconds was classified as having accomplished a one lag stance test. 5. Pain consisted of four components associated to different activities, namely walking, running, turning and jumping. Patients were classified as having pain when they reported they had pain during at least one of these activities.
Completion date	18/11/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	200
Total final enrolment	157
Key inclusion criteria	1. At least 18 years old 2. Diagnosed with an acute lateral ankle sprain caused by an inversion trauma 3. Had to visit one of the participating practices or emergency departments within 14 days after the inversion trauma
Key exclusion criteria	1. Patients who sustained an eversion trauma, multiple trauma or complicated trauma (including cartilage injuries, fractures and dislocation) 2. Had a history of ankle surgery 3. Mentally incompetent patients
Date of first enrolment	01/05/2006
Date of final enrolment	01/10/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Rudolf Magnus Institute of Neuroscience

Utrecht
3508 GA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/04/2015	17/12/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/12/2020: Publication reference and total final enrolment added.