Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NL20031.068.07
Study information
Scientific title
Prospective randomized controlled trial comparing tape versus semi-rigid brace treatment of patients with grade II and III ankle ligament rupture
Acronym
TAPELOC
Study hypothesis
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
Maastricht University Medical Center Ethical Committee, 03 December 2007, ref: MEC07-2-094
Study design
Prospective randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/01/2008
Overall trial end date
31/12/2011
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
01/01/2008
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
Department of Surgery
Maastricht
6226 BV
Netherlands
Sponsor information
Organisation
Maastricht University Medical Center (Netherlabnds)
Sponsor details
c/o Prof. Peter R.G. Brink
Department of Surgery
P. Debyelaan 25
PO Box 5800
Maastricht
6226 BV
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Maastricht University Medical Center (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary