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New treatment option for Residual Limb Pain
Official title Surgical Treatments for Postamputation Pain
ClinicalTrials.gov ID: NCT05009394
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Ongoing participation in a clinical study that the clinical investigator deems detrimental to participation in this study.
See the full eligibility 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 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Melbourne, Australia
- Edmonton, Alberta, Canada
- Santiago, Chile
- Bologna, Emilia-Romagna, Italy
- Mölndal, Västra Götaland County, Sweden
- Edinburgh, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; Melbourne, Australia; Edmonton, Alberta, Canada; Santiago, Chile and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.