ISRCTN - ISRCTN60890411: Improving sensory function after carpal tunnel surgery

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
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, 23rd December 2013, 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 below 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 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

15/02/2014

Overall trial end date

15/06/2015

Reason abandoned

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

Earlham Road
Norwich
NR4 7TJ
United Kingdom

Sponsor information

Organisation

University of East Anglia (UK)

Sponsor details