Targeted Muscle Reinnervation Treats Neuroma and Phantom Pain in Major Limb Amputees: A Randomized Clinical Trial.
Gregory A Dumanian, Benjamin K Potter, Lauren M Mioton...
https://pubmed.ncbi.nlm.nih.gov/30371518Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05009394
Surgical Treatments for Postamputation Pain Comparing Targeted Muscle Reinnervation, Regenerative Peripheral Nerve Interface, and Standard Neuroma Treatment
Led by Prometei Pain Rehabilitation Center · Updated on 2025-01-09
110
Participants Needed
9
Research Sites
156 weeks
Total Duration
On this page
Sponsors
P
Prometei Pain Rehabilitation Center
Lead Sponsor
V
Vastra Gotaland Region
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare the effectiveness of three surgical methods for reducing residual limb pain, neuroma pain, and phantom limb pain in people who have had a major limb amputation. These types of pain fall under the category of postamputation pain, which can have different causes requiring specific treatments. The trial is a multi-center, double-blind, randomized controlled study conducted at nine hospitals across seven countries, involving 110 participants. The study will follow participants for up to four years to observe how pain changes after surgery. The three surgical treatments being studied are Targeted Muscle Reinnervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), and standard neuroma treatment involving neuroma excision and muscle burying. Each surgery takes place in a hospital, lasting about 1 to 3 hours depending on the method. TMR involves rerouting injured nerves to nearby motor nerves; RPNI involves splitting the nerve into fascicles and wrapping them in muscle grafts; the standard treatment removes the painful neuroma and buries the nerve in nearby muscle tissue. Participants are randomly assigned to one of these treatments in equal groups. Participants will be followed up at 1, 3, 6, and 12 months after surgery, and again at 2 and 4 years to assess pain levels. Questionnaires previously used in clinical settings will measure residual limb pain, neuroma pain, and phantom limb pain intensity. After 12 months, participants and evaluators will learn which treatment was given, and those unhappy with results can discuss alternative treatments with their clinical investigator. The primary outcome measured is residual limb pain intensity from baseline to 12 months post-surgery, with secondary measures including neuroma and phantom limb pain intensities over the same period.
CONDITIONS
Brief Title
Surgical Treatments for Postamputation Pain
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- The participant must have a major limb amputation.
- The participant is 18 years old or older at the time of consent.
- The participant must be in generally good health to undergo surgery as judged by the clinical investigator.
- Time since the last amputation must be more than one year at the time of consent.
- The participant must have an average residual limb pain score of 4 or higher on the Numerical Rating Scale (0-10) after baseline.
- Pharmacological pain treatments must have had a stable dosage for at least one month before screening.
- Non-pharmacological pain treatments must have ended at least one month before screening.
- The participant must have had stable prosthetic fitting for at least one month before screening.
- The participant must understand the language used for assessments as judged by the clinical investigator.
You will not qualify if you...
- 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 on the nerve to be treated for postamputation pain.
- Mental disorders or language difficulties that impair understanding of study participation.
- Ongoing participation in another clinical study deemed detrimental by the clinical investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - 1 day
Participants undergo one of three surgical treatments for postamputation pain in a hospital setting.
1 visit (in-person, surgery day)
Post-operative Follow-up
Duration - 12 months
Participants are monitored to assess pain intensity and recovery after surgery through scheduled follow-up visits.
4 visits at 1, 3, 6, and 12 months post-surgery
Long-term Monitoring
Duration - Up to 4 years
Participants continue to be observed for long-term outcomes related to pain up to four years after surgery.
2 visits at 2 and 4 years post-surgery
Trial Site Locations
Total: 9 locations
1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Not Yet Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
3
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
4
Dandenong Hospital, Monash Health
Melbourne, Australia
Not Yet Recruiting
5
University of Alberta Hospital
Edmonton, Alberta, Canada, AB T6G 2B7
Not Yet Recruiting
6
Worker Hospital
Santiago, Chile
Not Yet Recruiting
7
Rizzoli Orthopedic Institute
Bologna, Emilia-Romagna, Italy, 40136
Actively Recruiting
8
Sahlgrenska University Hospital
Mölndal, Västra Götaland County, Sweden, 431 80
Not Yet Recruiting
9
NHS Lothian, NHS Clyde & Greater Glasgow, and NHS Grampian
Edinburgh, United Kingdom
Not Yet Recruiting
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Research Team
M
Max Ortiz Catalan, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Targeted muscle reinnervation: a novel approach to postamputation neuroma pain.
Jason M Souza, Jennifer E Cheesborough, Jason H Ko...
https://pubmed.ncbi.nlm.nih.gov/24562875Regenerative Peripheral Nerve Interfaces for the Treatment of Postamputation Neuroma Pain: A Pilot Study.
Shoshana L Woo, Theodore A Kung, David L Brown...
https://pubmed.ncbi.nlm.nih.gov/28293490Surgical treatments for postamputation pain: study protocol for an international, double-blind, randomised controlled trial.
Emily Pettersen, Paolo Sassu, Carina Reinholdt...
https://pubmed.ncbi.nlm.nih.gov/37131180Targeted Muscle Reinnervation Improves Pain and Ambulation Outcomes in Highly Comorbid Amputees.
Brian L Chang, Josh Mondshine, Christopher E Attinger...
https://pubmed.ncbi.nlm.nih.gov/34398088Targeted Muscle Reinnervation for Limb Amputation to Avoid Neuroma and Phantom Limb Pain in Patients Treated at a Pediatric Hospital.
Kim A Bjorklund, John Alexander, Kirsten Tulchin-Francis...
https://pubmed.ncbi.nlm.nih.gov/37063502Prophylactic Regenerative Peripheral Nerve Interfaces to Prevent Postamputation Pain.
Carrie A Kubiak, Stephen W P Kemp, Paul S Cederna...
https://pubmed.ncbi.nlm.nih.gov/31461024Preemptive Treatment of Phantom and Residual Limb Pain with Targeted Muscle Reinnervation at the Time of Major Limb Amputation.
Ian L Valerio, Gregory A Dumanian, Sumanas W Jordan...
https://pubmed.ncbi.nlm.nih.gov/30634038Regenerative Peripheral Nerve Interface: Surgical Protocol for a Randomized Controlled Trial in Postamputation Pain.
Emily Pettersen, Paolo Sassu, Francesca Alice Pedrini...
https://pubmed.ncbi.nlm.nih.gov/38557950Targeted Muscle Reinnervation: Surgical Protocol for a Randomized Controlled Trial in Postamputation Pain.
Emily Pettersen, Paolo Sassu, Francesca Alice Pedrini...
https://pubmed.ncbi.nlm.nih.gov/38526122