Tape versus brace treatment of ankle distortion
| ISRCTN | ISRCTN58932628 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58932628 |
| Secondary identifying numbers | NL20031.068.07 |
- Submission date
- 21/03/2011
- Registration date
- 28/07/2011
- Last edited
- 28/07/2011
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Martijn Poeze
Scientific
Scientific
Department of Surgery
P. Debyelaan 25
PO Box 5800
Maastricht
6226 BV
Netherlands
Study information
| Study design | Prospective randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Prospective randomized controlled trial comparing tape versus semi-rigid brace treatment of patients with grade II and III ankle ligament rupture |
| Study acronym | TAPELOC |
| Study objectives | Treatment of lateral ankle sprain with a semi-rigid brace leads to less local complications and more patient satisfaction than treatment with tape. Reduction in complications will improve patient satisfaction with the treatment method and this will improve functional outcome by enhancing compliance with the treatment method used. |
| Ethics approval(s) | Maastricht University Medical Center Ethical Committee, 03 December 2007, ref: MEC07-2-094 |
| Health condition(s) or problem(s) studied | Ankle distortion, ankle ligament rupture |
| Intervention | 1. Tape treatment: after randomisation tape immobilisation is started 5-8 days after initial treatment with immobilisation using bandage 2. Taping is performed by a select group of experienced and skilled healthcare professionals of the outpatient clinic 3. The tape consists of three layers 4. The first layer is a latex free, adhesive, bandage to protect the skin (Coban, 3M) 5. The second layer consists of 2.5cm non-elastic strapping tape (Leukotape, Beiersdorff) used for support 6. The third layer consists of Elastoplasts 6cm broad, elastic used for fixation of the second layer (BDF, Beiersdorf) 7. This taping is applied twice with two weeks interval 8. The other group is treated with a semi-rigid brace (AirLoc ® Bauerfeind, Zeulenroda, Germany) 9. After instructions to the patient how to reapply the brace, revision of these instructions is made after 2 weeks 10. Total duration of both treatment is 4 weeks 11. Follow-up duration is 12 weeks after randomization |
| Intervention type | Other |
| Primary outcome measure | 1. Patient satisfaction is assessed by verbal rating scale: poor (5), moderate (4), sufficient (3), good (2) and excellent (1) both at 2 and 4 weeks after start of the study treatment 2. Level of pain is evaluated using the visual analogue scale at baseline, 2, 4, 8 and 12 weeks 3. Ankle joint function is assessed using the validated Karlsson scoring scale at 2, 4, 8 and 12 weeks after start of the study treatment 4. Range of motion is measured using an electronic goniometer at 2, 4, 8 and 12 weeks after start of the study treatment |
| Secondary outcome measures | Any complications of the treatments |
| Overall study start date | 01/01/2008 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | Patients were included if they sustained a grade II or III ankle sprain (significant damage to lateral ligaments defined by the presence of a lateral hematoma and tenderness at the anterior lateral ligament without or with instability) and were presented in the outpatient clinic within 5-7 days. |
| Key exclusion criteria | 1. Fracture 2. Age was under 16 or over 55 years 3. If they had experienced a previous ankle sprain or fracture 4. If they sustained swelling that makes tape treatment impossible |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Department of Surgery
Maastricht
6226 BV
Netherlands
6226 BV
Netherlands
Sponsor information
Maastricht University Medical Center (Netherlabnds)
University/education
University/education
c/o Prof. Peter R.G. Brink
Department of Surgery
P. Debyelaan 25
PO Box 5800
Maastricht
6226 BV
Netherlands
| Website | http://www.maastrichtuniversity.nl/ |
|---|---|
"ROR" |
https://ror.org/02d9ce178 |
Funders
Funder type
Hospital/treatment centre
Maastricht University Medical Center (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
