RecruitingNAINTERVENTIONAL

Surgical Treatments for Postamputation Pain

This study is looking into new surgical ways to help people who experience pain after losing a limb, known as 'post-amputation pain'. This includes pain in the remaining limb (stump pain), phantom limb pain (feeling pain in the missing limb), and nerve pain. Researchers want to see if two newer operations, called Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Nerve Interface (RPNI), are more effective than a standard operation. Participants will be monitored over four years to see how well these treatments work. The aim is to find better ways to manage this type of pain.

At a glance

Status

Recruiting

Phase

Sponsor

Prometei Pain Rehabilitation Center

Enrolment target

110

Start

20 Jun 2023

Estimated completion

01 Jun 2029

Residual Limb Pain Amputation Neuroma Phantom Limb Pain Pain, Neuropathic Pain, Nerve

What is this study about?

When someone has lost a limb, they can sometimes experience different types of pain in the area, such as pain in the remaining part of the limb (stump pain), nerve pain, or even feeling pain in the limb that's no longer there (phantom limb pain). This can be a really challenging and difficult experience for many.

Doctors are always looking for better ways to help people with this pain. This study focuses on surgery as a way to ease these symptoms. It's comparing three different surgical techniques. Two of these, Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Nerve Interface (RPNI), are newer approaches. The third is a more standard operation often used to treat nerve pain after an amputation. By comparing them directly, researchers hope to find out which methods are most effective in the long run.

This research is a 'double-blind, randomised controlled trial'. This means that neither the patients nor the doctors involved in assessing the results will know which specific operation each person received, until a certain point in the study. This helps make sure the results are fair and unbiased. The study is taking place in several hospitals across different countries, including a few in the UK, and will follow participants for four years to understand the lasting effects of the treatments.

Key takeaways

Compares three surgical treatments for post-amputation pain.
Investigates newer surgeries (TMR, RPNI) against standard treatment.
Study is 'double-blind' for fair results.
Follows participants for four years to check long-term effects.
Aims to find better ways to manage pain after limb loss.

Who may be eligible?

To join this study, you must be at least 18 years old and have had a major limb amputation more than a year ago. You should also generally be in good health for surgery, as decided by the study doctor. A key requirement is that you have ongoing pain in your remaining limb that scores 4 or more out of 10 on a pain scale, even after standard treatments.

If you're taking medication for pain, the dose needs to have been steady for at least a month. If you've had other pain treatments like nerve stimulation or mirror therapy, these should have finished at least a month before joining. You also need to have a stable artificial limb fitting for at least a month.

There are also reasons why you might not be able to join. These include certain nerve, brain, or mental health conditions, an active infection in the remaining limb, or if you've already had one of the specific newer operations (TMR or RPNI) for this pain. If you're involved in another study that might affect this research, you also might not 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?
Did your amputation happen more than a year ago?
Do you have a stable artificial limb (if you use one) for at least a month?
Is your remaining limb pain usually 4 out of 10 or higher?
Are you generally well enough for surgery?
Do you not have an active infection in your remaining limb?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be randomly assigned to receive one of three different surgical treatments for your pain. Neither you nor the doctors assessing your progress will know which specific surgery you received until after 12 months.

You'll have several follow-up appointments to check on your pain and recovery. These will happen at 1, 3, 6, and 12 months after your operation, and then again at 2 and 4 years. After the 12-month check-up, you and the assessment team will be told which treatment you received. If you're not happy with the results of your treatment, you can discuss other options with your doctor at the study site.

Potential risks and benefits

Taking part in any study involves some potential benefits and risks. The main benefit here is the chance to receive a surgical treatment that might help reduce your post-amputation pain, potentially improving your daily life. However, as with any surgery, there are risks, such as infection or complications from the procedure itself. The research aims to find out which treatments are most effective and safe. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (9)

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

Northwestern Memorial Hospital
Verified postcode
Chicago, United States· Not yet recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Not yet recruiting
University of Michigan Health System
Verified postcode
Ann Arbor, United States· Not yet recruiting
Dandenong Hospital, Monash Health
Verified postcode
Melbourne, Australia· Not yet recruiting
University of Alberta Hospital
Verified postcode
Edmonton, Canada· Not yet recruiting
Worker Hospital
Verified postcode
Santiago, Chile· Not yet recruiting
Rizzoli Orthopedic Institute
Verified postcode
Bologna, Italy· Recruiting
Sahlgrenska University Hospital
Verified postcode
Mölndal, Sweden· Not yet recruiting
NHS Lothian, NHS Clyde & Greater Glasgow, and NHS Grampian
Verified postcode
Edinburgh, United Kingdom· Not yet recruiting

Common questions

What is 'post-amputation pain'?

It's different types of pain that can occur after losing a limb, like pain in the remaining stump, nerve pain, or feeling pain in the missing limb (phantom limb pain).

What are TMR and RPNI?

These are two newer types of surgery being studied to help treat post-amputation pain, by working with the nerves and muscles.

Will I know which surgery I receive?

No, not initially. For the first 12 months, both you and the assessing doctors won't know, to keep the study fair. You'll be told after 12 months.

Where is this study happening in the UK?

It's taking place at NHS Lothian, NHS Clyde & Greater Glasgow, and NHS Grampian.

How long will I be involved in the study?

You will be followed up for a total of four years after your surgery.

How to find out more

Max Ortiz Catalan, PhD

maxortizc@outlook.com +46708461065 Official trial record

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