Comparing surgical techniques for postamputation pain relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Rizzoli Orthopedic Institute
  Bologna, Emilia-Romagna, Italy Recruiting
• 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

Study contacts

• Principal investigator: Max Ortiz Catalan, PhD — Prometei Pain Rehabilitation Center
• Study coordinator: Max Ortiz Catalan, PhD
• Email: maxortizc@outlook.com
• Phone: +46708461065

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.