Comparing surgical techniques for postamputation pain relief

Surgical Treatments for Postamputation Pain

This study is testing three different surgical methods to see which one helps people who have had a limb amputated feel less pain in their residual limb, neuroma, and phantom sensations.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Prometei Pain Rehabilitation Center (other)
• Locations: 9 sites (Chicago, Illinois and 8 other locations)
• Trial ID: NCT05009394 on ClinicalTrials.gov

What this trial studies

This clinical trial is a double-blind randomized controlled trial that evaluates the effectiveness of three surgical techniques—Targeted Muscle Reinnervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), and standard neuroma treatment—in alleviating residual limb pain, neuroma pain, and phantom limb pain. The study will recruit 110 participants who have undergone major limb amputation and will follow them for up to four years to assess pain relief outcomes. Participants will be randomly assigned to one of the three treatment groups and monitored at various intervals post-surgery to evaluate the long-term effectiveness of the interventions.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have undergone major limb amputation and experience significant residual limb pain.

Not a fit: Patients who have not had a major limb amputation or those with stable pain levels below the threshold may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve pain management for patients suffering from postamputation pain.

How similar studies have performed: Previous studies have shown promise in using surgical interventions for postamputation pain, but this specific comparison of techniques is novel.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Chicago, Illinois and 8 other locations

• Northwestern Memorial Hospital — Chicago, Illinois, United States (NOT_YET_RECRUITING)
• Massachusetts General Hospital — Boston, Massachusetts, United States (NOT_YET_RECRUITING)
• University of Michigan Health System — Ann Arbor, Michigan, United States (NOT_YET_RECRUITING)
• Dandenong Hospital, Monash Health — Melbourne, Australia (NOT_YET_RECRUITING)
• University of Alberta Hospital — Edmonton, Alberta, Canada (NOT_YET_RECRUITING)
• Worker Hospital — Santiago, Chile (NOT_YET_RECRUITING)
• Rizzoli Orthopedic Institute — Bologna, Emilia-Romagna, Italy (RECRUITING)
• Sahlgrenska University Hospital — Mölndal, Västra Götaland County, Sweden (NOT_YET_RECRUITING)
• NHS Lothian, NHS Clyde & Greater Glasgow, and NHS Grampian — Edinburgh, United Kingdom (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Max Ortiz Catalan, PhD — Prometei Pain Rehabilitation Center
• Study coordinator: Max Ortiz Catalan, PhD

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