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โ† Trials
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Surgical Treatments for Postamputation Pain

RecruitingNAAges 18 Years - anyAllPrometei Pain Rehabilitation Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * The participant must have a major limb amputation. * The participant is โ‰ฅ 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.
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What it tests

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

9 sites
Northwestern Memorial Hospital
Chicago, United States
Massachusetts General Hospital
Boston, United States
University of Michigan Health System
Ann Arbor, United States
Dandenong Hospital, Monash Health
Melbourne, Australia
University of Alberta Hospital
Edmonton, Canada
Worker Hospital
Santiago, Chile
Rizzoli Orthopedic Institute
Bologna, Italy
Sahlgrenska University Hospital
Mรถlndal, Sweden

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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