Surgical Treatments for Postamputation Pain

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

Surgical Treatments for Postamputation Pain

Surgical Treatments for Postamputation Pain

Condition
Residual Limb Pain
Intervention / Treatment

-

Contacts and Locations

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60611

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Ann Arbor

University of Michigan Health System, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Center for Bionics and Pain Research,

Max Ortiz Catalan, PhD, PRINCIPAL_INVESTIGATOR, Center for Bionics and Pain Research

Study Record Dates

2028-06