Actively Recruiting
Surgical Treatments for Postamputation Pain
Led by Prometei Pain Rehabilitation Center · Updated on 2025-01-09
110
Participants Needed
9
Research Sites
310 weeks
Total Duration
On this page
Sponsors
P
Prometei Pain Rehabilitation Center
Lead Sponsor
V
Vastra Gotaland Region
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Surgical Treatments for Postamputation Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The participant must have a major limb amputation.
- The participant is 63 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Not Yet Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
3
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
4
Dandenong Hospital, Monash Health
Melbourne, Australia
Not Yet Recruiting
5
University of Alberta Hospital
Edmonton, Alberta, Canada, AB T6G 2B7
Not Yet Recruiting
6
Worker Hospital
Santiago, Chile
Not Yet Recruiting
7
Rizzoli Orthopedic Institute
Bologna, Emilia-Romagna, Italy, 40136
Actively Recruiting
8
Sahlgrenska University Hospital
Mölndal, Västra Götaland County, Sweden, 431 80
Not Yet Recruiting
9
NHS Lothian, NHS Clyde & Greater Glasgow, and NHS Grampian
Edinburgh, United Kingdom
Not Yet Recruiting
Research Team
M
Max Ortiz Catalan, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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