Surgical Treatments for Postamputation Pain
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
πŸ—“οΈ Study Start (Actual) 20 June 2023
πŸ—“οΈ Primary Completion (Estimated) June 2025
βœ… Study Completion (Estimated) June 2028
πŸ‘₯ Enrollment (Estimated) 110
πŸ”¬ Study Type INTERVENTIONAL
πŸ“Š Phase NA
Locations:
πŸ“ Chicago, Illinois, United States
πŸ“ Boston, Massachusetts, United States
πŸ“ Ann Arbor, Michigan, United States
πŸ“ Melbourne, Australia
πŸ“ Edmonton, Alberta, Canada
πŸ“ Santiago, Chile
πŸ“ Bologna, Emilia-Romagna, Italy
πŸ“ MΓΆlndal, VΓ€stra GΓΆtaland, Sweden
πŸ“ Edinburgh, United Kingdom

πŸ“‹ Eligibility Criteria

Description

    Inclusion Criteria:

    • * The participant must have a major limb amputation.
    • * The participant is β‰₯ 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

πŸ—“οΈ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 July 2021
  • First Submitted that Met QC Criteria 11 August 2021
  • First Posted 17 August 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 September 2023
  • Last Update Posted 29 September 2023
  • Last Verified September 2023