CompletedPhase IObservational

Neurostimulation for nociceptive pain

This study is exploring a new treatment for ongoing knee pain caused by osteoarthritis or pelvic pain due to endometriosis. The treatment involves a small device, similar to a pacemaker, that medical staff will place near specific nerves in your back. This device sends gentle electrical pulses, which we believe could help change how pain signals travel to your brain, potentially reducing your pain. We're using a device that's already approved for other types of pain and is covered by the NHS. If you've tried other treatments for your pain without success and are looking for new options, this study might be for you. Your involvement will help us understand if this treatment can help people with these specific conditions and guide how we develop even better pain relief options in the future.

At a glance

Status

Completed

Phase

Phase I

Sponsor

ABVF B.V.

Enrolment target

Start

15 Mar 2024

Estimated completion

28 Feb 2026

Analgesic treatment of knee osteoarthritis and endometriosis

What is this study about?

This study is looking into a new way to help people who have long-term (chronic) pain from either knee osteoarthritis or endometriosis. Many people find their pain hard to manage, even after trying different treatments. We're investigating if a special type of treatment, called neurostimulation, can make a difference. This involves using a small, approved device that sends gentle electrical pulses to specific nerves in your back, called the lumbar sympathetic chain. We believe these pulses might change the way your body sends pain messages to your brain, which could lead to less pain.

The device we're using is already available and has been approved for safety in the UK. While it's used for other types of pain, we want to understand if it can also help with knee pain from osteoarthritis or pelvic pain from endometriosis. Previous studies with similar devices have shown they can reduce pain for up to a year in other conditions. We hope this study will show similar benefits for you and help us gather important information to improve future treatments for people with these conditions.

Your participation would not only explore a potential new treatment for your pain but also help scientists develop even better, smaller, and easier-to-use devices in the future. By joining, you'll be contributing to scientific understanding that could make a real difference for many others suffering from similar pain.

Key takeaways

Exploring a new treatment for ongoing knee or pelvic pain.
Uses a small, approved device that sends mild electrical pulses to nerves.
Aims to reduce pain by changing how pain signals are sent to the brain.
Designed for people who haven't found enough relief from other treatments.
Participation could help improve future pain treatments for many others.
You can choose to leave the study at any time.

Who may be eligible?

This study is specifically looking for people who have been living with ongoing knee pain due to osteoarthritis or pelvic pain due to endometriosis for at least six months. Your pain should be affecting your daily life, and you should have already tried other common treatments like medicines or physiotherapy without getting enough relief.

To be considered, you should be willing to explore new treatment options. If your pain is mainly in your knee or pelvis rather than other areas, and your doctor thinks this type of nerve stimulation could be a suitable option for you, then you might be eligible. There are also specific age ranges: for knee pain, you should be between 30 and 75, and for pelvic pain from endometriosis, you should be a pre-menopausal woman between 18 and 50. If you are able to become pregnant, you would need to use contraception throughout the study.

There's also a limit on the amount of strong pain medication you might be taking. If it's higher than a certain level, the study might offer support to reduce it. Our medical team will carefully review all your information to see if this study is the right fit for you.

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.

Do I have knee pain from osteoarthritis or pelvic pain from endometriosis, lasting over 6 months?
Does my pain affect my daily activities?
Have I tried other treatments (like medicines or physiotherapy) for my pain without success?
Am I willing to explore a new treatment option?
Can I distinguish my main knee/pelvic pain from other body pains?
Am I within the age limits for my condition (18-75 for knee OAR, 18-50 for endometriosis)?

Answer every question to see your result.

What does participation involve?

If you are interested and deemed suitable, your journey in the study would begin with a screening visit to confirm you meet all the criteria. If you agree to take part, and after you fully understand and sign an informed consent form, a small device will be carefully placed near the intended nerve in your back during a minor procedure. This procedure is done by medical staff using X-ray guidance to ensure accuracy. The device has a battery and thin wires (leads) that deliver mild electrical pulses to the nerve.

Throughout the study, you'll have appointments to check on your progress and how the device is working. The study is expected to run from September 2023 to December 2026. At the end of the study, you'll have a choice: you can either have the device removed during a simple procedure, or if it has helped your pain, you can continue to use it and move to standard NHS after-care for similar devices. If the treatment isn't helping your pain, the device can be safely removed.

Potential risks and benefits

Taking part in this study offers the potential benefit of reducing your long-standing pain from knee osteoarthritis or endometriosis. The information we gather will also significantly help us learn more about treating these types of chronic pain, and your contribution will support the development of even better, smaller devices in the future. However, like any medical procedure, there are some risks involved with the device implantation. These include a small chance of bleeding (about 1 in 300 cases, which might need further surgery), the device moving or not working properly over its long lifespan (about 1 in 10 cases might need further surgery), or an infection (about 3 in 100 cases, sometimes requiring removal of the device). There's also a very rare risk of an allergic reaction to materials in the implant (1 in 1000 cases) or nerve damage (1 in 3000 cases). The device itself could also stop working (3 in 100 cases), and it might prevent you from having certain types of MRI scans. The procedure also involves X-rays, which carry a very slight, long-term increase in your lifetime risk of cancer (from 50% to 50.02%). You are free to withdraw from the study at any time.

Locations (1)

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

Leeds Teaching Hospitals NHS Trust
City only
Leeds, England

Common questions

What is neurostimulation?

It's a way of using mild electrical pulses from a small implanted device to change how pain signals are sent to your brain, potentially reducing your pain.

Is the device safe?

Yes, the device is already approved for safety in the UK (CE marked) and is covered by the NHS for other uses.

What conditions is this study for?

This study is for long-term knee pain caused by osteoarthritis or long-term pelvic pain caused by endometriosis.

Will I have to pay for anything?

No, all aspects of the study treatment and visits are covered as part of your participation.

What happens if the device doesn't help my pain?

If the device doesn't help, it can be safely removed during a minor procedure, and you can go back to your usual care.

How to find out more

Arun Sridhar

arun.sridhar@abvf.bio +44 (0)7542927522 Official trial record

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