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ISRCTN
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ISRCTN30848329
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ClinicalTrials.gov identifier
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Public title
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Sensory Re-learning after Carpal Tunnel syndrome
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Scientific title
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A pilot randomised controlled trial to evaluate the feasibility and acceptability of a sensory re-learning intervention after carpal tunnel decompression
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Acronym
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SeRCaT
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Serial number at source
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10263
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Study hypothesis
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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.
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Lay summary
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Lay summary under review
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Ethics approval
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Norfolk Research Ethics Committee, 24th November 2010, ref: 10/H0310/57
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Study design
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Randomised interventional
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Musculoskeletal impairment associated with Carpal tunnel syndrome
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Participants - inclusion criteria
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1. Patients who have had carpal tunnel decompression and are at least 4 months post surgery
2. Aged 18 years old or older
3. Return a valid signed consent form
4. 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)
5. An abnormal result in at least 2 tests from a battery of 4 sensory assessments
6. Target Gender: Male & Female
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Participants - exclusion criteria
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Those whose scores on all 4 sensibility tests are within a normal range
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Anticipated start date
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04/02/2011
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Anticipated end date
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31/05/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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UK Sample Size: 30
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Interventions
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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
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Primary outcome measure(s)
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Sensory function at 4 weeks and 8 weeks
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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NIHR (UK)
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Trial website
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Publications
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Contact name
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Dr
Christina
Jerosch-Herold
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Address
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School of Allied Health Professions
The Queen's Building
Earlham Road
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City/town
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Norwich
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Zip/Postcode
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NR4 7TJ
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Country
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United Kingdom
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Sponsor
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University of East Anglia (UK)
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Address
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School of Medicine
Health Policy and Practice
Earlham Road
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City/town
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Norwich
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Zip/Postcode
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NR4 7TJ
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Country
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United Kingdom
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Sponsor website:
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http://www.uea.ac.uk/
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Date applied
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28/07/2011
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Last edited
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11/10/2011
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Date ISRCTN assigned
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28/07/2011
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