Targeted Muscle Reinnervation (TMR) Versus Regenerative Peripheral Nerve Interfaces (RPNI) Versus the Combined Technique of TMR-RPNI to Reduce Chronic and Phantom Limb Pain in Oncologic Amputees: A Randomized Control Pilot Study
M.D. Anderson Cancer Center
Summary
This clinical trial evaluates two surgical techniques (targeted muscle re-innervation \[TMR\] and regenerative peripheral nerve interfaces \[RPNI\]) alone and in combination for the alleviation of chronic residual limb and phantom limb pain in cancer patients who have had an amputation. Chronic residual limb pain and phantom limb pain are debilitating outcomes of traumatic and oncologic amputation. Emerging microsurgical treatments for post-amputation pain are very promising. TMR and RPNI are both approved surgical techniques that involve connecting cut nerves to parts of the muscle as a way to heal and protect the nerves. This trial evaluates these techniques alone and in combination for the treatment of residual and phantom limb pain in cancer patients who have received an amputation.
Description
PRIMARY OBJECTIVE: Determine the relative effectiveness of three surgical techniques, TMR, RPNI, and TMR with RPNI, on chronic and phantom limb pain in the oncologic amputee using the validated Numerical Rating Scale (NRS) and Patient-Reported Outcomes Measurement Information System (PROMIS) Behavior, Intensity, Interference, and Global Health Forms. SECONDARY OBJECTIVES: I. To estimate the rate and total quantity of any pain medication use among oncology amputees who received one of the three surgical techniques. II. To estimate the rate of prosthetic use among oncologic amputees. III. To…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients greater than or equal to 18 years of age who are receiving an amputation for oncologic reasons * Patients with available mixed major nerves and donor motor nerves in the amputation stump or reconstructive tissue * Patients able to complete informed consent Exclusion Criteria: * Patients under 18 years of age * Patients unable to give consent * Patients receiving an amputation for non-oncologic purposes * Patients with amputations performed for immediate palliation (life expectancy less than 3 months), as this technique takes a minimum of 3-6 months for effect…
Interventions
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureRegenerative Peripheral Nerve Interface Surgery
Undergo regenerative peripheral nerve interface surgery
- ProcedureTargeted Muscle Reinnervation
Undergo targeted muscle reinnervation
Location
- M D Anderson Cancer CenterHouston, Texas