RESTORE-MSK: Reducing Sympathetic Tone with nVNS for MSK Pain Relief
Research type
Research Study
Full title
A randomised, single-blind, sham-controlled, crossover pilot study assessing the effect of non-invasive vagus nerve stimulation (nVNS) on autonomic symptoms and pain management in patients with chronic musculoskeletal pain and autonomic dysfunction.
IRAS ID
360822
Contact name
Manoj Sivan
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 5 months, 5 days
Research summary
Chronic musculoskeletal (MSK) pain, such as long-lasting back, joint, or widespread body pain, is estimated to affect around 20–33% of people worldwide and is a major cause of disability. Many people with chronic MSK pain also experience autonomic dysfunction (AD). This is a problem with the body’s automatic control systems, leading to symptoms like dizziness, heart palpitations, digestive issues, and extreme tiredness. Current drug treatments often do not help people with both chronic pain and autonomic problems.
A new approach - non-invasive vagus nerve stimulation (nVNS) - may an alternative treatment option. This treatment uses a handheld device, called gammaCore, which delivers a gentle electrical pulse to the vagus nerve in the neck. The vagus nerve helps control both pain pathways and autonomic function. nVNS has already been shown to reduce pain in migraine and cluster headache, but its potential benefit for MSK pain with AD has not been tested.
This pilot study will investigate whether nVNS can improve symptoms of autonomic dysfunction and pain in people with chronic MSK pain. It will also test how acceptable and practical the treatment is for patients, and whether a larger trial is feasible.
The study will recruit 12 adults with chronic MSK pain and autonomic dysfunction at Chapel Allerton Hospital, Leeds. Participants will be randomly assigned to use GammaCore device in active or inactive mode before crossing over to the other option. Each treatment phase will last two weeks, separated by a two-week break. Participants will use the device twice daily and record their experience in a diary.
Researchers will measure changes in autonomic symptoms, pain levels, quality of life, anxiety, and depression using validated questionnaires.
The study is sponsored by the University of Leeds. If successful, it could lead to a new non-drug treatment option for people living with the combined burden of chronic pain and autonomic dysfunction.REC name
London - South East Research Ethics Committee
REC reference
26/LO/0045
Date of REC Opinion
28 Jan 2026
REC opinion
Further Information Favourable Opinion