Surgical Techniques for Phantom and Residual Limb Pain After Amputation
This study is looking at two surgical techniques, Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Nerve Interfaces (RPNI), to help cancer patients who have had an amputation and are experiencing chronic residual limb pain or phantom limb pain. These techniques involve connecting cut nerves to muscles to help them heal. Researchers want to see if using TMR, RPNI, or a combination of both is most effective in reducing pain. They will also look at how much pain medication you use and if you use a prosthetic limb. This study is for adults aged 18 and older who are having an amputation for cancer reasons and have suitable nerves for these procedures. The study aims to understand the safety and effectiveness of these treatments.
- Study design
- This interventional study plans to enroll 45 participants. You would be randomly assigned to one of three groups: TMR alone, RPNI alone, or TMR combined with RPNI.
- What's involved
- You would undergo one of the surgical procedures and then have follow-up appointments at 3, 6, and 12 months after the surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for an average of 1 year to monitor safety and adverse events.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Target Muscle Re-innervation and Regenerative Peripheral Nerve Interfaces Alone and in Combination for the Treatment of Residual and Phantom Limb Pain in Cancer Patients Who Have Received an Amputation
At a glance
Conditions
NCT06840262
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
M D Anderson Cancer Center
Houston, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Margaret S Roubaud · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Inclusion
Exclusion
What this trial measures
- Safety and Adverse Events (AEs)Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0