PROSpeCT
Research type
Research Study
Full title
PROSpeCT: Pre-Operative electrical Stimulation to improve outcomes after Carpal Tunnel decompression OR A single-centre, randomised, parallel group, placebo-controlled study to compare the impact of non-invasive pre-operative electrical stimulation versus placebo on nerve regeneration following decompression surgery for carpal tunnel syndrome
IRAS ID
328027
Contact name
Max Stewart
Contact email
Sponsor organisation
University of Oxford / Research Governance, Ethics and Assurance
ISRCTN Number
ISRCTN94245451
Duration of Study in the UK
2 years, 6 months, 31 days
Research summary
PROSpeCT is about improving recovery after surgery for carpal tunnel syndrome. Carpal tunnel syndrome is a hand disease, involving compression of the median nerve at the wrist. The median nerve controls the muscles of the thumb and feeling in much of the hand. Compression of the nerve leads to pain, tingling and weakness. Most people with CTS eventually need wrist surgery to decompress the nerve. However, as many as one in four people still get symptoms after their surgery. We want to explore a new treatment which could improve the results of the surgery. This treatment uses electric pulses to stimulate the median nerve. We know that electric pulses can help nerves heal after surgery, but currently this treatment requires implanting electrodes. Implanting electrodes makes operations longer, riskier, and more complicated. PROSpeCT is about electrically stimulating nerves through the skin (non-invasively) instead.
We will recruit people with CTS from surgical waiting lists in Oxfordshire. People will be randomly assigned to receive one hour of either real or placebo stimulation before their operation. Everyone will still get the ‘gold standard’ surgery. We will collect information on hand and nerve function before surgery, and at three months and six months afterwards.
We are most interested in seeing if the treatment improves the feeling in people’s hands after surgery. However, we will also test whether people’s strength and use of their hands has improved. We will also take samples of skin from the finger and perform wrist MRI scans, so we can look directly at how the nerve is healing.
In the short term, this research could help people with CTS. In the long term, we hope to use electrical stimulation in other types of nerve injury.
PROSpeCT is funded by the Medical Research Council and the British Society for Surgery of the Hand.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
24/SC/0036
Date of REC Opinion
13 Mar 2024
REC opinion
Further Information Favourable Opinion