Surgical Treatments for Postamputation Pain
Prometei Pain Rehabilitation Center
110 participants
Jun 20, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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 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 Criteria5
- 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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Interventions
Surgical procedure used to rewire injured proximal nerves to motor nerves directly innervating an otherwise redundant target muscle.
Surgical procedure where the the nerve is split into fascicles and wrapped in free muscle grafts.
Surgical procedure where the neuroma is excised and the nerve stump is buried in an adjacent deep muscle.
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT05009394