Condition category
Injury, Occupational Diseases, Poisoning
Date applied
21/03/2011
Date assigned
28/07/2011
Last edited
28/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martijn Poeze

ORCID ID

Contact details

Department of Surgery
P. Debyelaan 25
PO Box 5800
Maastricht
6226 BV
Netherlands

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

http://www.maastrichtuniversity.nl/

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

Publication citations

Additional files

Editorial Notes