Back to search results

Surgical Treatments for Postamputation Pain

This study is looking at three different surgical procedures to help people who have pain after an amputation. These pains include residual limb pain (pain in the remaining part of the limb), neuroma pain (pain from nerve bundles), and phantom limb pain (pain that feels like it's coming from the missing limb). The three surgeries being compared are Targeted Muscle Reinnervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), and a standard treatment called neuroma excision and muscle burying. Researchers want to see which surgery best reduces pain intensity over 12 months. You might be able to join if you are at least 18 years old, have had a major limb amputation over a year ago, and are healthy enough for surgery. The study aims to enroll 110 participants.

Study design
This is a double-blind, randomized controlled trial. About 110 participants will be randomly assigned to one of the three surgical treatments.
What's involved
You would undergo one of three surgical procedures. You would be followed for 4 years, with pain intensity measured at various times up to 12 months after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 4 years after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05009394

Surgical Treatments for Postamputation Pain

Recruiting
NAAges 18+InterventionalTreatment
Prometei Pain Rehabilitation Center
~110 participants
Updated 2025-01-09 on ClinicalTrials.gov
What's tested:Targeted Muscle Reinnervation (TMR)Regenerative Peripheral Nerve Interface (RPNI)Standard neuroma treatment, neuroma excision, and muscle burying

At a glance

Recruiting sites
1 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Residual limb pain intensity
Measured over Baseline to 12-month post-surgery

Conditions

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

Explore related trials

Amputation NeuromaNeuropathic PainPhantom Limb PainResidual Limb Pain

Where it's being run

9 sites across 9 states
Illinois1
Massachusetts1
Michigan1
Australia1
Alberta1
Chile1
Emilia-Romagna1
Västra Götaland County1

Study leadership

  • Max Ortiz Catalan, PhD · PRINCIPAL_INVESTIGATOR · Prometei Pain Rehabilitation Center

Who to contact

Max Ortiz Catalan, PhD
[email protected]
+46708461065
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

The participant must have a major limb amputation.
The participant is ≥ 18 years old at the time of consent.
The participant must be in generally good health to undergo a surgical intervention, as per the clinical investigator's opinion.
Time since the last amputation must be over a year at the time of consent.
The participant must have an average residual limb pain score equal or greater than 4 on the Numerical Rating Scale (NRS, 0-10) after the baseline period.
If the participant has been prescribed pharmacological treatments for pain, there must be no variations in dosage (steady consumption) for at least 1 month before the screening visit.
If the participant has been prescribed non-pharmacological treatments for pain, such as spinal cord stimulation, transcutaneous electrical nerve stimulation, and mirror therapy, the treatment must have ended at least 1 month before the screening visit.
The participant must have a stable prosthetic fitting for at least a month before the screening visit.
The participant has a sufficient understanding of the language in which the assessments will be conducted, as per the clinical investigator's opinion.

Exclusion

Neurological or other conditions that affect nerve regeneration for the nerve to be treated.
Active infection in the residual limb.
Prior RPNI or TMR surgery of the nerve to be treated (with painful neuroma) to address postamputation pain.
Mental disorders (e.g., schizophrenia, paranoia, psychosis, etc.), reluctance, or language difficulties that result in difficulty understanding the meaning of study participation.
Ongoing participation in a clinical study that the clinical investigator deems detrimental to participation in this study.

What this trial measures

  • Residual limb pain intensityBaseline to 12-month post-surgery

    Difference in residual limb pain intensity will be measured by numerical rating scale (NRS, 0-10), where 0 - no pain and 10 - worst imaginable pain, between baseline period and at the 12-month follow-up visit.