Condition category
Nervous System Diseases
Date applied
18/05/2006
Date assigned
22/06/2006
Last edited
31/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.pulvertafthandcentre.org.uk

Contact information

Type

Scientific

Primary contact

Prof Frank Burke

ORCID ID

Contact details

Pulvertaft Hand Centre
Derby Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RD/33646/1, 06/Q2401/77

Study information

Scientific title

Acronym

C-Trac

Study hypothesis

C-Trac™ is a safe and useful splint for treating carpal tunnel syndrome.

Ethics approval

Derbyshire Research Ethics Committee, 18/08/2006, ref: 06/Q2401/77; Trust ref: DHRD/2006/037

Study design

Prospective randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Carpal tunnel syndrome

Intervention

Comparing the C-Trac™ splint versus the conventional resting splint

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Levine questionnaire scores in each group at 8 weeks

Secondary outcome measures

1. Grip, pinch and sensation scores at 8 weeks
2. Levine questionnaire scores, grip, pinch and sensation scores at 0 and 4 weeks and at 6, 12, 24 and 60 months

Overall trial start date

22/06/2006

Overall trial end date

21/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Patients less than 65 years of age presenting to the Pulvertaft Hand Centre with a diagnosis of mild or moderate carpal tunnel syndrome, confirmed by nerve conduction studies and clinical assessment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25 patients in each group

Participant exclusion criteria

1. Severe carpal tunnel syndrome (based on nerve conduction studies and clinical assessment)
2. Previous carpal tunnel decompression on affected wrist
3. Previous steroid injection into affected carpal tunnel
4. 65 years of age or older
5. History of gout, hypothyroidism, previous fragility fracture, symptomatic basal joint arthritis, septic or rheumatoid arthritis of the hand, previous wrist fracture, diabetes mellitus, pregnancy, amyloidosis, acromegaly, renal dialysis, current oral steroid use
6. Current or very recent involvement in hand or related research
7. Regular use of hand-held vibrating tools
8. Ongoing involvement in compensation cases
9. Contact allergy to rubber or plastics
10. Patients who are unable to give informed consent

Recruitment start date

22/06/2006

Recruitment end date

21/06/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Pulvertaft Hand Centre
Derby
DE1 2QY
United Kingdom

Sponsor information

Organisation

Derby Hospitals NHS Foundation Trust (UK)

Sponsor details

Assistant Director of Research and Development
Research and Development Office
Derby Hospitals National Health Service (NHS) Foundation Trust
University of Nottingham Medical School at Derby
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3DT
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

Heritage Medical Ltd. will initially contribute 25 C-Trac™ splints to the study, at a retail cost of £5000, and should C-Trac™ prove to be effective, further C-Trac™ splints will be provided.

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

2013 results in:
Pilot randomised controlled trial comparing C-Trac splints with Beta Wrist Braces for the management of carpal tunnel syndrome.
Hand Therapy June 2013 vol. 18 no. 2 35-41

Publication citations

Additional files

Editorial Notes