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NCT05009394 · ClinicalTrials.gov registry record · NA
Surgical Treatments for Postamputation Pain
A NA study of Phantom Limb Pain and Pain, Neuropathic, sponsored by Prometei Pain Rehabilitation Center.
- Recruiting
- Registry status
- NA
- Development phase
- 110
- Enrollment target
- 9
- Study locations
NCT05009394: Recruiting NA study of Phantom Limb Pain and Pain, Neuropathic, sponsored by Prometei Pain Rehabilitation Center.
NCT05009394 is a NA study of Phantom Limb Pain and Pain, Neuropathic that is actively recruiting participants, run by Prometei Pain Rehabilitation Center. The registered enrollment target is 110 participants, roughly in line with the 113-participant average among 12 other Phantom Limb Pain trials with a reported enrollment target. The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05009394, a NA study of Phantom Limb Pain and Pain, Neuropathic, is actively recruiting participants, sponsored by Prometei Pain Rehabilitation Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 110 participants
- Enrollment target
- 9
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Targeted Muscle Reinnervation (TMR)
- PROCEDURE Regenerative Peripheral Nerve Interface (RPNI)
- PROCEDURE Standard neuroma treatment, neuroma excision, and muscle burying
Study Locations (9)
Other
- Dandenong Hospital, Monash Health - Melbourne
- Worker Hospital - Santiago
- NHS Lothian, NHS Clyde & Greater Glasgow, and NHS Grampian - Edinburgh
Illinois
- Northwestern Memorial Hospital - Chicago
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- University of Michigan Health System - Ann Arbor
Alberta
- University of Alberta Hospital - Edmonton
Emilia-Romagna
- Rizzoli Orthopedic Institute - Bologna
Västra Götaland County
- Sahlgrenska University Hospital - Mölndal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2023-06-20 |
| Est. Completion | 2029-06 |
| Phase | NA |
What NCT05009394 shows while recruiting
NCT05009394 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 113-participant average among 12 other Phantom Limb Pain trials with a reported enrollment target.
The record links to 5 conditions, with Phantom Limb Pain appearing as the primary indexed condition, and to 3 interventions - of which Targeted Muscle Reinnervation (TMR) is the first listed.
NCT05009394 lists 9 locations in 7 states (Other, Illinois, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT05009394 about?
NCT05009394 is a clinical study titled "Surgical Treatments for Postamputation Pain". 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 N...
What is the current status of trial NCT05009394?
This trial is currently recruiting. It is a NA study. The enrollment target is 110 participants. The study started on 2023-06-20. Estimated completion is 2029-06.
What conditions does trial NCT05009394 study?
This clinical trial studies the following conditions: Phantom Limb Pain, Pain, Neuropathic, Residual Limb Pain, Amputation Neuroma, Pain, Nerve.
What interventions are being tested in trial NCT05009394?
The interventions under investigation include: Targeted Muscle Reinnervation (TMR) (PROCEDURE), Regenerative Peripheral Nerve Interface (RPNI) (PROCEDURE), Standard neuroma treatment, neuroma excision, and muscle burying (PROCEDURE).
Who is sponsoring clinical trial NCT05009394?
This trial is sponsored by Prometei Pain Rehabilitation Center, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05009394 being conducted?
This trial has 9 study locations across Illinois, Massachusetts, Michigan, Alberta, Emilia-Romagna. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Phantom Limb Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05009394's enrollment target sits among peer trials
110 5th of 12 higher than 8 of 12 other Phantom Limb Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phantom Limb Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Home-based Rehabilitation Intervention for Phantom Limb Pain in Veterans With Lower Limb Amputations
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-
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-
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-
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