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 are 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 are invited for a clinical assessment of hand sensibility using validated tests of sensory function. Those in whom sensory impairment is confirmed by these tests are then invited to participate in the study. Consenting patients are randomly allocated to receive either sensory relearning for 6 weeks or standard practice. All patients are 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?
February 2014 to July 2015
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Christina Jerosch-Herold
c.jerosch-herold@uea.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Ms Julie Houghton
ORCID ID
Contact details
Earlham Road
Norwich
NR4 7TJ
United Kingdom
-
J.Houghton@uea.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15771
Study information
Scientific title
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
Acronym
IMPACTS
Study hypothesis
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?
Ethics approval
East of England Norfolk REC, 23/12/2013, ref: 13/EE/0419
Study design
Randomised; Interventional; Design type: Not specified, Treatment
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 to request a patient information sheet
Condition
Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
Intervention
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.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
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
15/02/2014
Overall trial end date
15/06/2015
Reason abandoned (if study stopped)
Eligibility
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
Participant type
Patient
Age group
Adult
Gender
Both
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
15/02/2014
Recruitment end date
15/06/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
Funders
Funder type
Government
Funder name
NIHR Senior Research Fellowship; Grant Codes: NIHR-SRF-2012-05-119
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
Basic results (scientific)
Publication list
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27402282