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Regenerative Medicine
Surgical Treatments for Postamputation Pain
N/A
Recruiting
Led By Max Ortiz Catalan, PhD
Research Sponsored by Center for Bionics and Pain Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must have a major limb amputation
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to12-month post-surgery
Awards & highlights
Study Summary
This trial compares 3 surgical treatments to reduce pain in amputated limbs. Patients will be followed up for 4 years to compare effectiveness.
Who is the study for?
This trial is for adults over 18 who've had a major limb amputation at least a year ago and are experiencing significant residual or phantom limb pain. They should be in good health for surgery, not have had prior TMR or RPNI surgeries on the affected nerve, and must not be dealing with infections or certain mental disorders that could impact their participation.Check my eligibility
What is being tested?
The study compares three surgical techniques to relieve postamputation pain: Targeted Muscle Reinnervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), and standard neuroma treatment involving excision and muscle burying. It's a double-blind RCT where patients will be monitored for four years.See study design
What are the potential side effects?
While specific side effects aren't listed, common risks of surgical procedures may include infection, bleeding, scarring, pain at the incision site, possible damage to surrounding tissues or nerves, and general anesthesia complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a major limb amputation.
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My average pain score is 4 or more on a scale of 0 to 10.
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I am 18 years old or older.
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It has been over a year since my last amputation.
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I stopped any non-drug pain treatments like electrical stimulation or mirror therapy over a month ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to12-month post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to12-month post-surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Residual limb pain intensity
Secondary outcome measures
Neuroma pain intensity
Phantom limb pain intensity
Trial Design
3Treatment groups
Active Control
Group I: Targeted Muscle Reinnervation (TMR)Active Control1 Intervention
The surgical procedure comprises three steps: preparation of the donor nerve, identification of a motor branch to the targeted muscle, and nerve coaptation. To prepare the donor nerve, the surgeon will identify the nerve with a painful neuroma and resect the neuroma up to healthy fascicles. Next, the surgeon will identify a motor branch to a nearby target muscle and will confirm muscle contraction using a hand-held nerve stimulator. The motor branch to the target muscle will be transected as close as possible to its entry point without tension. In the final step, the previous nerve stump from which the neuroma was resected will be transferred and coapted to the newly severed motor branch that innervates the target muscle and secured by 2-3 non-resorbable monofilament sutures. The surgery time is approximately 2-3 hours and it takes place in the hospital.
Group II: Regenerative Peripheral Nerve Interface (RPNI)Active Control1 Intervention
The RPNI procedure involves construction of a residual peripheral nerve split into several nerve fascicles and implanted into free skeletal muscle grafts. First, the surgeon identifies the nerve with a painful neuroma and resect the neuroma up to healthy fascicles. Then, a longitudinal intraneural dissection will be performed exposing its fascicles. Next, autologous muscle grafts will be harvested from a healthy donor site, and the dissected nerve stumps will be placed parallel to the muscle fibers. The nerve stump will be secured to the muscle graft, thereafter the graft will be wrapped around the nerve stump and anchored in the folded graft, thus creating an RPNI. This will be repeated for each fascicle obtained from splitting the transected nerve. Lastly, the RPNIs will be placed in a protected area. The surgery time is approximately 2-3 hours and it takes place in the hospital.
Group III: Standard neuroma treatment, neuroma excision, and muscle buryingActive Control1 Intervention
The standard neuroma treatment, also called neuroma transposition, includes excision of the terminal neuroma and burying the nerve into an adjacent deep muscle.The standard neuroma treatment entails the excision of the terminal neuroma and then implanting the nerve into an adjacent muscle. Firstly, the surgeon will identify the nerve with a painful neuroma and thereafter resect the neuroma up to healthy fascicles. Next, the surgeon will identify a nearby muscle which is not involved in joint motion and has limited output opportunities for the nerve. The nerve will then be channeled at least 1 cm inside the muscle without applying any tension to it and secured by 1-2 non-resorbable monofilament sutures. The identified nerve with the painful neuroma will not be treated with any additional therapy than the resection (e.g., diathermy, pharmacotherapy, crushing, etc.). The surgery time is approximately 1-2 hours and it takes place in the hospital.
Find a Location
Who is running the clinical trial?
Center for Bionics and Pain ResearchLead Sponsor
Vastra Gotaland RegionOTHER_GOV
274 Previous Clinical Trials
1,145,840 Total Patients Enrolled
Hospital del Trabajador de SantiagoOTHER
2 Previous Clinical Trials
712 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that affects nerve healing in the area needing treatment.I have had a major limb amputation.I have been using a stable prosthetic fitting for at least a month.My average pain score is 4 or more on a scale of 0 to 10.I have an infection in the part of my limb that remains after amputation.It has been over a year since my last amputation.I am 18 years old or older.My pain medication dose has been the same for at least 1 month.I stopped any non-drug pain treatments like electrical stimulation or mirror therapy over a month ago.I had surgery on a nerve for a painful growth after an amputation.
Research Study Groups:
This trial has the following groups:- Group 1: Targeted Muscle Reinnervation (TMR)
- Group 2: Regenerative Peripheral Nerve Interface (RPNI)
- Group 3: Standard neuroma treatment, neuroma excision, and muscle burying
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many facilities are managing the implementation of this clinical trial?
"Massachusetts General Hospital in Boston, University of Michigan Health System in Ann Arbor and Dandenong Hospital, Monash Health in Melbourne are amongst the places where this trial is recruiting. Additionally, there are 10 more sites across the country taking part."
Answered by AI
Are there still vacancies available to volunteer in this clinical test?
"The research data posted on clinicaltrials.gov states that this trial, originally posted in June of 2023 and last updated at the end of May, is no longer seeking participants. However, there are 170 other trials actively recruiting people across multiple sites as we speak."
Answered by AI
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