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Recruiting Not applicable

Surgical Treatments for Postamputation Pain

NCT05009394 · tracked via the Priya Life Science Italy tracker
Sponsor
Prometei Pain Rehabilitation Center
Phase
Not applicable
Started
2023-06-20
Last updated
2025-01-09

Condition(s) studied

Residual Limb PainAmputation NeuromaPhantom Limb PainPain, NeuropathicPain, Nerve

Investigational drug(s) / intervention(s)

Targeted Muscle Reinnervation (TMR)Regenerative Peripheral Nerve Interface (RPNI)Standard neuroma treatment, neuroma excision, and muscle burying

Targeted Muscle Reinnervation (TMR): Surgical procedure used to rewire injured proximal nerves to motor nerves directly innervating an otherwise redundant target muscle.

Regenerative Peripheral Nerve Interface (RPNI): Surgical procedure where the the nerve is split into fascicles and wrapped in free muscle grafts.

Standard neuroma treatment, neuroma excision, and muscle burying: Surgical procedure where the neuroma is excised and the nerve stump is buried in an adjacent deep muscle.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Residual limb pain intensity — Baseline 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.

Trial sites (9)

FacilityCityRegionStatus
Northwestern Memorial Hospital Chicago Illinois Not Yet Recruiting
Massachusetts General Hospital Boston Massachusetts Not Yet Recruiting
University of Michigan Health System Ann Arbor Michigan Not Yet Recruiting
Dandenong Hospital, Monash Health Melbourne Australia Not Yet Recruiting
University of Alberta Hospital Edmonton Alberta Not Yet Recruiting
Worker Hospital Santiago Chile Not Yet Recruiting
Rizzoli Orthopedic Institute Bologna Emilia-Romagna Recruiting
Sahlgrenska University Hospital Mölndal Västra Götaland County Not Yet Recruiting
NHS Lothian, NHS Clyde & Greater Glasgow, and NHS Grampian Edinburgh United Kingdom Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05009394 on ClinicalTrials.gov ↗ ← All trials in Italy