Not yet recruitingNAINTERVENTIONAL

Non-invasive Vagus Nerve Stimulation for Chronic Musculoskeletal Pain

This study, called RESTORE-MSK, is for adults in the UK who have ongoing muscle and joint pain (lasting 12 weeks or more) and also experience problems with their body's automatic systems, such as feeling dizzy when standing up or having digestion issues. We are investigating if a non-invasive device, called gammaCore Sapphire, which gives gentle electrical pulses to a nerve in the neck, can help reduce pain and improve these automatic system symptoms. Participants will use the device at home for two short periods, with a break in between. The study aims to see if this treatment is helpful and gather information for a larger future study.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University of Leeds

Enrolment target

Start

14 May 2026

Estimated completion

31 Jul 2026

Chronic Musculoskeletal Pain Autonomic Dysfunction Dysautonomia

What is this study about?

Many people live with long-term pain in their muscles and joints, which can be caused by injuries, overuse, or conditions like arthritis. We know that these types of pain can often go hand-in-hand with problems in what's called the 'autonomic nervous system'. This is the part of your body that automatically controls things like your heart rate, blood pressure, digestion, and even how tired you feel. When this system isn't working quite right, it can make your pain worse and cause other uncomfortable symptoms like feeling lightheaded or having stomach issues.

Traditional treatments for muscle and joint pain often don't specifically target these autonomic system problems. However, there's a device called non-invasive vagus nerve stimulation (nVNS), which gently stimulates a nerve in your neck (the vagus nerve) using mild electrical pulses. This nerve is a key player in the autonomic nervous system. Some studies have already shown that stimulating this nerve can help with pain in other conditions like migraines and fibromyalgia.

This small study, called RESTORE-MSK, wants to explore if this nVNS device (specifically the gammaCore Sapphire) could be a new, non-drug way to help adults who have both long-term muscle and joint pain and these autonomic system issues. We're hoping to find out if it can reduce their pain and improve their other related symptoms. The results from this pilot study will help us understand if it's worth doing a bigger study in the future.

Key takeaways

Targets long-term muscle and joint pain with autonomic symptoms.
Uses a gentle electrical stimulation device on the neck.
Compares active treatment with a 'sham' (inactive) treatment.
Aims to reduce pain and improve automatic body functions.
Results will help plan a larger study if promising.
Participation involves using the device at home for short periods.

Who may be eligible?

This study is looking for adults who are at least 18 years old and have been experiencing pain in their muscles and joints for 12 weeks or longer. A key part of qualifying is also having signs of what we call 'autonomic dysfunction'. This means that some of your body's automatic functions, like your heart rate, digestion, or sweating, aren't working as smoothly as they should, which we'll check with a special questionnaire.

To join, you need to be able to understand and sign a consent form, follow the study instructions, and be available for about six weeks. You also need to be able to read and understand English well enough to complete study forms.

You cannot join if you are pregnant, have severe heart disease (like a recent heart attack or very serious heart failure), or have certain electronic devices inside your body like a pacemaker, a cochlear implant, or another electrical stimulator. You also cannot be using any other electrical stimulation devices for treatment during the study. If you can't give informed consent, you won't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you had muscle or joint pain for 12 weeks or more?
Do you have symptoms that suggest problems with your body's automatic functions (e.g., dizziness, digestion issues)?
Do you *not* have a pacemaker or other implanted electronic device?
Are you *not* pregnant or have severe heart problems?
Can you understand English and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you join the RESTORE-MSK study, you'll be one of 12 participants. After an initial visit to check if you're suitable, you'll be given a small handheld device called gammaCore Sapphire. This device delivers gentle electrical pulses to a nerve in your neck. You will be shown exactly how to use it safely at home, by placing it on your neck near your jawbone, twice a day (morning and evening), for two minutes on each side of your neck.

Because this is a 'crossover' study, you'll go through two treatment periods. For one 14-day period, you'll use the active device, and for another 14-day period, you'll use a version of the device that feels similar but delivers a very low, non-active stimulation (a 'sham' treatment). There will be a two-week break, called a 'washout period', between these two treatment periods. You won't know whether you're getting the active or sham treatment first. Throughout the study, you'll complete questionnaires about your pain, how you're feeling, your quality of life, and your autonomic symptoms. There will also be some simple tests, like checking your body's response to standing up. The total time you'll be involved in the study is about six weeks.

Potential risks and benefits

Participating in this study might offer a potential benefit if the vagus nerve stimulation helps to reduce your pain and improve your autonomic symptoms. However, as this is a pilot study, we don't yet know if it will be effective for everyone, or at all. There might be some mild side effects from using the device, such as skin redness where it’s applied, or a tingling sensation. We will explain all known potential risks to you. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Trust, Chapeltown Road, Leeds, LS7 4SA, United Kingdom
Verified postcode
Leeds, United Kingdom

Common questions

What is 'autonomic dysfunction'?

It means some of your body's automatic functions, like heart rate, blood pressure, digestion, or sweating, aren't working as smoothly as they should, which can cause symptoms like dizziness or fatigue.

What is 'non-invasive vagus nerve stimulation'?

It's a way to gently stimulate a specific nerve in your neck (the vagus nerve) using a small device that delivers mild electrical pulses through your skin, without needing surgery.

Will I know if I'm getting the real treatment or the 'sham' treatment?

No, you won't know at the time. This is called 'single-blind' and helps us get unbiased results, as both you and the researchers will be unaware of which treatment you are receiving at any given time.

What if I experience side effects?

You should report any side effects to the study team immediately. They will guide you on what to do and document everything carefully.

Where is the study taking place?

The study is based at Chapel Allerton Hospital in Leeds, UK.

How to find out more

Norah Almutairi

ml22n2aa@leeds.ac.uk +44 (0)113 392 4396 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.