Condition category
Nervous System Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
16/07/2009
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

Mr A K Singh

ORCID ID

Contact details

University Hospital
Nottingham
NG7 2UH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0192128859

Study information

Scientific title

Acronym

Study hypothesis

The purpose of the study will be to see whether preserving the flexor sheath during decompression of the carpal tunnel improves recovery.
We believe that by trying to keep an extra piece of tissue beneath the median nerve will provide a smooth gliding surface and aid recovery in time and function.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Nervous System Diseases: Carpal tunnel syndrome (CTS)

Intervention

Randomised Controlled Trial to see whether preserving the flexor sheath during decompression of the carpal tunnel improves recovery.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Grip strengths
2. scar pain
3. Patient Evaluation Measure score

Secondary outcome measures

Not provided at time of registration

Overall trial start date

30/07/2003

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. 100 affected patients (50 patients and 50 control patients)
2. male or female
3. aged 20-70

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

30/07/2003

Recruitment end date

31/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Queen's Medical Centre University Hospital NHS Trust (UK)

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17079401

Publication citations

  1. Results

    Forward DP, Singh AK, Lawrence TM, Sithole JS, Davis TR, Oni JA, Preservation of the ulnar bursa within the carpal tunnel: does it improve the outcome of carpal tunnel surgery? A randomized, controlled trial., J Bone Joint Surg Am, 2006, 88, 11, 2432-2438, doi: 10.2106/JBJS.F.00013.

Additional files

Editorial Notes