Condition category
Nervous System Diseases
Date applied
28/07/2011
Date assigned
28/07/2011
Last edited
29/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Carpal tunnel syndrome (CTS) is a common condition that causes pain, numbness and tingling in the hand and fingers. The median nerve runs the length of the arm, and is responsible for controlling sensation and movement in the thumb and first three fingers. In order to enter the hand, this nerve must run though a narrow passage of small bones and tough fibres in the wrist, known as the carpal tunnel. Swelling can narrow this tunnel so that the median nerve is compressed (nerve entrapment), causing CTS. Carpal tunnel decompression, also known as carpel tunnel release surgery, is a simple operation that that is recommended if the symptoms of carpal tunnel are particularly severe. During the surgery, a ligament in the wrist is cut, which relieves pressure on the median nerve.

Who can participate?
Adults who have had carpal tunnel decompression surgery at least four months ago, who report numbness or difficulty doing up buttons.

What does the study involve?
Participants undergo four sensory tests, to determine whether there are any problems with the way the can feel. They are then randomly allocated into one of two groups. Those in the first group receive “sensory re-learning”, which involves practising a set of exercises every day for four weeks. Those in the second group are not given “sensory re-learning” exercises to practise for the four week study period. At the end of the study period, and after another four weeks, the sensory assessments are repeated.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
University of East Anglia (UK)

When is the study starting and how long is it expected to run for?
February 2011 to May 2011

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Christina Jerosch-Herold

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christina Jerosch-Herold

ORCID ID

Contact details

School of Allied Health Professions
The Queen's Building
Earlham Road
Norwich
NR4 7TJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10263

Study information

Scientific title

A pilot randomised controlled trial to evaluate the feasibility and acceptability of a sensory re-learning intervention after carpal tunnel decompression

Acronym

SeRCaT

Study hypothesis

This study is looking at the effect of a home based sensory relearning programme in patients who continue to have sensory impairment after carpal tunnel decompression. Surgical decompression for moderate or severe carpal tunnel syndrome (CTS) is the most longterm effective treatment for symptom relief and return to function. However recovery of functional sensibility and muscle strength is not always complete especially in patients with a long duration of symptoms and more severe presurgical impairment. Rehabilitative interventions such as sensory relearning programmes have been shown to improve sensibility in the hand after peripheral nerve trauma and stroke but there are no trials to date which have explored whether this treatment works in patients after carpal tunnel decompression. This preliminary trial aims to evaluate what effect sensory relearning has on sensibility and hand function and to assess the acceptability and feasibility of conducting a larger scale trial in the future. Patients who have undergone carpal tunnel decompression at least four months earlier will be invited to respond to a screening questionnaire which asks them about the severity of any numbness and difficulty in using their hand. Those who report numbness and difficulty with handling small objects will be invited to attend the clinical trials unit to have a full assessment of their hand sensibility. Validated tests of sensory function will be used to objectively assess the extent of any sensory impairment. Those with impairment will then be invited to participate in the trial, whereby patients will be randomly (‘by the toss of coin’) allocated to either receive sensory relearning for 4 weeks or no intervention. All patients will be reassessed at 4 and 8 weeks after the initial assessment and the results between the two groups compared.

Ethics approval

Norfolk Research Ethics Committee, 24th November 2010, ref: 10/H0310/57

Study design

Randomised interventional

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

Musculoskeletal impairment associated with Carpal tunnel syndrome

Intervention

1. Sensory relearning programme - a home programme involving 4 weeks of daily exercises in which through vision, attention and learning discrimination of textures and objects is practised and integrated in everyday activities
2. Follow Up Length: 2 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Sensory function at 4 weeks and 8 weeks

Secondary outcome measures

No secondary outcome measures

Overall trial start date

04/02/2011

Overall trial end date

31/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients who have had carpal tunnel decompression and are at least 4 months post surgery
2. Aged 18 years old or older
3. Respond as having at least mild numbness or mild difficulty with doing up buttons, this will be assessed via 2 screening questions taken from the Boston Carpal Tunnel Questionnaire (FS 6 and 11)
4. An abnormal result in at least 2 tests from a battery of 4 sensory assessments

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 30

Participant exclusion criteria

Those whose scores on all 4 sensibility tests are within a normal range

Recruitment start date

04/02/2011

Recruitment end date

31/05/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Allied Health Professions
Faculty of Medicine and Health Sciences University of East Anglia
Norwich
NR4 7TJ
United Kingdom

Sponsor information

Organisation

University of East Anglia (UK)

Sponsor details

School of Medicine
Health Policy and Practice
Earlham Road
Norwich
NR4 7TJ
United Kingdom

Sponsor type

University/education

Website

http://www.uea.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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