Surgical Treatments for Postamputation Pain

Recruiting now · Not applicable

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

In brief

This is a double-blind randomised controlled trial (RCT) which compares the effectiveness of three surgical techniques for alleviating residual limb pain (RLP), neuroma pain and phantom limb pain (PLP). The three surgical treatments are Targeted Muscles Reinnervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), and an active control (neuroma excision and muscle burying). Patients will be follow-up for 4 years.

Key facts

Study ID

NCT05009394

Run by

Prometei Pain Rehabilitation Center

People needed

110

Starts

2023-06-20

Expected to finish

2029-06-01

Last updated by the study team

2025-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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