Plain English Summary
Background and study aims
This study is looking at the effect of a home based sensory relearning programme in patients who continue to have sensory loss after a surgery to treat carpal tunnel syndrome (numbness or tingling sensation in hands and fingers). Numbness or loss of finger sensation can continue after surgery especially in patients with a long duration of symptoms and more severe pre-surgical impairment. Patients find it difficult to use their hand in everyday tasks like picking up small objects. Sensory relearning can be taught to patients and has been shown in nerve injuries to improve the sensibility and function of the hand. The aim of this study is to find out the effect of sensory relearning in a large group of patients.
Who can participate?
Patients who have undergone carpal tunnel decompression surgery 12 months ago or more.
What does the study involve?
Patients will be sent a short screening questionnaire asking them to indicate whether they have sensory impairments and to rate the severity of it. Those who report mild or worse sensory impairments will be invited for a clinical assessment of hand sensibility using validated tests of sensory function. Those in whom sensory impairment is confirmed by these tests will then be invited to participate in the study. Consenting patients will be randomly (by the toss of coin) allocated to receive either sensory relearning for 6 weeks or standard practice. All patients will be reassessed at 6 and 12 weeks after the initial assessment and the results between the two groups are compared to establish whether sensory relearning improves sensory function.
What are the possible benefits and risks of participating?
Those who receive sensory relearning may find improvement in their sensory function.
Where is the study run from?
The study is being undertaken at the Norwich Clinical Trials Unit (UK) in collaboration with the Department of Orthopaedics at the Norfolk and Norwich University Hospital, UK.
When is the study starting and how long is it expected to run for?
The study is due to begin in February 2014 and will be completed by July 2015.
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Dr Christina Jerosch-Herold
Ms Julie Houghton
A pragmatic, assessor-blinded randomized trial of the clinical effectiveness of a 6-week sensory relearning home programme on tactile function of the hand after carpal tunnel decompression
Is a 6-week patient-led home programme of sensory relearning effective in improving tactile gnosis and function of the hand in patients with long-term sensory impairments after carpal tunnel decompression?
East of England Norfolk REC, 23rd December 2013, 13/EE/0419
Randomised; Interventional; Design type: Not specified, Treatment
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
Stratified blocked randomisation (random permuted block lengths of 2,4 and 6 stratified by STI score at baseline (≤3 points)) will be used. The randomised sequence will be generated independently by the Clinical Trials Unit data manager and held on a dedicated website.
Patients are randomised to two groups:
1. Sensory Re-learning: A standardised Sensory Relearning (SR) home programme will be given to patients including materials, instructions and a diary. Patients will be shown how to carry out the exercises and asked to practise these daily over 6 weeks. Short but frequent sessions (at least 3 times per day of around 10 minutes each) will be encouraged.
2. The control group will not be given any active treatment, which is current standard practice. They will be asked to continue using their hand as they have before.
At the end of their trial participation (final 12 week follow-up assessment) patients in the control group will be given a standardised information sheet which will enable them to replicate the materials from common items available at home and exercises if they wish.
Primary outcome measures
Tactile gnosis assessed by Shape-texture identification test; Timepoint(s): 6 weeks and 12 weeks
Secondary outcome measures
1. Locognosia; Timepoint(s): 6 and 12 weeks
2. Michigan Hand Questionnaire; Timepoint(s): 6 and 12 weeks
3. Moberg pick-up test; Timepoint(s): 6 and 12 weeks
4. Touch threshold; Timepoint(s): 6 and 12 weeks
Overall trial start date
Overall trial end date
Participant inclusion criteria
For part 1 screening:
Patients who have had a carpal tunnel decompression at the NNUH Dept of Orthopaedics at least 12 months earlier, aged 18 or over.
For part 2 trial: patients who have had their hand sensation assessed, in whom at least 2 out of 3 sensory tests show results below normal and who have given fully informed consent
Target number of participants
Planned Sample Size: 124; UK Sample Size: 124
Participant exclusion criteria
1. Patients who do not appear to be able to give fully informed consent or do not consent to being randomised (that is those who express a strong preference for the treatment)
2. Patients in whom the sensory tests are within normal range
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
NIHR Senior Research Fellowship; Grant Codes: NIHR-SRF-2012-05-119
Funding Body Type
Funding Body Subtype
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