Surgical Treatments for Postamputation Pain
Condition(s) studied
Investigational drug(s) / intervention(s)
Targeted Muscle Reinnervation (TMR): Surgical procedure used to rewire injured proximal nerves to motor nerves directly innervating an otherwise redundant target muscle.
Regenerative Peripheral Nerve Interface (RPNI): Surgical procedure where the the nerve is split into fascicles and wrapped in free muscle grafts.
Standard 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.
Study 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
Primary outcome measure(s)
- Residual limb pain intensity — Baseline to 12-month post-surgery
Difference in residual limb pain intensity will be measured by numerical rating scale (NRS, 0-10), where 0 - no pain and 10 - worst imaginable pain, between baseline period and at the 12-month follow-up visit.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | Not Yet Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Not Yet Recruiting |
| University of Michigan Health System | Ann Arbor | Michigan | Not Yet Recruiting |
| Dandenong Hospital, Monash Health | Melbourne | Australia | Not Yet Recruiting |
| University of Alberta Hospital | Edmonton | Alberta | Not Yet Recruiting |
| Worker Hospital | Santiago | Chile | Not Yet Recruiting |
| Rizzoli Orthopedic Institute | Bologna | Emilia-Romagna | Recruiting |
| Sahlgrenska University Hospital | Mölndal | Västra Götaland County | Not Yet Recruiting |
| NHS Lothian, NHS Clyde & Greater Glasgow, and NHS Grampian | Edinburgh | United Kingdom | Not Yet Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05009394 on ClinicalTrials.gov ↗ ← All trials in Sweden