Surgical Treatments for Postamputation Pain

Launched by PROMETEI PAIN REHABILITATION CENTER · Aug 11, 2021

Keywords

ClinConnect Summary

This clinical trial is studying different surgical methods to help people who experience pain after losing a limb, known as residual limb pain, as well as pain from neuromas (nerve growths) and phantom limb pain (feeling pain in a limb that is no longer there). The trial compares three surgical techniques: Targeted Muscles Reinnervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), and a standard procedure that involves removing the neuroma and burying the muscle. The aim is to see which of these treatments is most effective in reducing pain.

To participate, individuals must be at least 18 years old, have had a major limb amputation for over a year, and currently experience moderate to severe pain (rated 4 or higher on a scale from 0 to 10). Participants should be in generally good health and have a stable prosthetic fitting. The study will follow participants for four years, and they can expect regular check-ins about their pain and recovery. It's important to note that those with certain health issues or prior surgeries related to this pain may not be eligible. If you or a loved one are interested, this trial could offer new insights into managing pain after an amputation.

Gender

ALL

Eligibility criteria

• Inclusion 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 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 Criteria:
• • 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.