Surgical Treatments for Postamputation Pain
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that if you are taking pain medications, your dosage must not change for at least one month before the screening visit. This means you can continue your current medications as long as the dosage remains steady.
What data supports the effectiveness of the treatment for postamputation pain?
Is the surgical treatment for postamputation pain generally safe for humans?
Research on targeted muscle reinnervation (TMR) and regenerative peripheral nerve interface (RPNI) suggests these procedures are generally safe and can reduce pain after amputation, improving quality of life. These techniques have been used in various patient populations, including those with cancer and vascular issues, with reported benefits in pain reduction and improved prosthetic function.12345
How is the treatment for postamputation pain using TMR and RPNI different from other treatments?
The treatment using Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Nerve Interface (RPNI) is unique because it provides new targets for nerves to connect with, which can help reduce pain from nerve injuries after amputation. This approach can improve the quality of life by reducing phantom and nerve pain, unlike traditional methods that may rely more on medications.12345
Research Team
Max Ortiz Catalan, PhD
Principal Investigator
Prometei Pain Rehabilitation Center
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgical Treatment
Participants undergo one of three surgical treatments: Targeted Muscle Reinnervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), or standard neuroma treatment
Short-term Follow-up
Participants are monitored for pain intensity and recovery at 1, 3, 6, and 12 months post-surgery
Long-term Follow-up
Participants are monitored for pain intensity and recovery at 2 and 4 years post-surgery
Open-label Extension (optional)
Participants may request alternative treatments if unsatisfied with initial outcomes, followed by medical evaluation and further treatment options
Treatment Details
Interventions
- Regenerative Peripheral Nerve Interface (RPNI)
- Standard Neuroma Treatment, Neuroma Excision and Muscle Burying
- Standard Neuroma Treatment, Neuroma Transposition
- Targeted Muscle Reinnervation (TMR)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Center for Bionics and Pain Research
Lead Sponsor
Prometei Pain Rehabilitation Center
Lead Sponsor
Vastra Gotaland Region
Collaborator
Hospital del Trabajador de Santiago
Collaborator
NHS Lothian
Collaborator
NHS Greater Clyde and Glasgow
Collaborator
NHS Grampian
Collaborator
Northwestern Memorial Hospital
Collaborator
University of Michigan
Collaborator
Massachusetts General Hospital
Collaborator