Improving sensory function after carpal tunnel surgery
| ISRCTN | ISRCTN60890411 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60890411 |
| Secondary identifying numbers | 15771 |
- Submission date
- 16/01/2014
- Registration date
- 16/01/2014
- Last edited
- 09/08/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Earlham Road
Norwich
NR4 7TJ
United Kingdom
| J.Houghton@uea.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Not specified, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | IMPACTS |
| Study objectives | 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(s) | East of England Norfolk REC, 23/12/2013, ref: 13/EE/0419 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 15/02/2014 |
| Completion date | 15/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 124; UK Sample Size: 124 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/02/2014 |
| Date of final enrolment | 15/06/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NR4 7TJ
United Kingdom
Sponsor information
University/education
Earlham Road
Norwich
NR4 7TJ
England
United Kingdom
"ROR" |
https://ror.org/026k5mg93 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
09/08/2017: Publication reference added.
