Surgical Treatments for Postamputation Pain
Prometei Pain Rehabilitation Center
Summary
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.
Description
Residual limb pain (RLP), neuroma pain, and phantom limb pain (PLP) can develop after the loss of a body part and fall within the umbrella term postamputation pain. However, the underlaying causes to postamputation pain are diverse and must be addressed accordingly. Surgical treatments for RLP have become a popular approach and have shown great potential for successful outcomes. The two surgical interventions, Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Nerve Interface (RPNI), are globally used in pain management therapies. This is a multi-centre, double-blind, superiority…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * The participant must have a major limb amputation. * The participant is ≥ 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 variat…
Interventions
- ProcedureTargeted Muscle Reinnervation (TMR)
Surgical procedure used to rewire injured proximal nerves to motor nerves directly innervating an otherwise redundant target muscle.
- ProcedureRegenerative Peripheral Nerve Interface (RPNI)
Surgical procedure where the the nerve is split into fascicles and wrapped in free muscle grafts.
- ProcedureStandard neuroma treatment, neuroma excision, and muscle burying
Surgical procedure where the neuroma is excised and the nerve stump is buried in an adjacent deep muscle.
Locations (9)
- Northwestern Memorial HospitalChicago, Illinois
- Massachusetts General HospitalBoston, Massachusetts
- University of Michigan Health SystemAnn Arbor, Michigan
- Dandenong Hospital, Monash HealthMelbourne
- University of Alberta HospitalEdmonton, Alberta
- Worker HospitalSantiago