Disclosures: Jennifer C. Lee, MS: No financial relationships or conflicts of interest

Objective: Postamputation pain decreases quality of life, prosthetic use, and functional status. Regenerative peripheral nerve interface (RPNI) surgery can treat and prevent postamputation pain. This study examines the effects of RPNI surgery on postamputation pain, psychosocial wellbeing, and prosthetic use.

Design: Prospective cohort study comprising 2 Arms

Setting: Patients were recruited at the University of Michigan.

Participants: Arm 1 comprised major lower extremity amputation patients with pre-existing postamputation pain. Arm 2 comprised patients with planned major lower limb amputation with or without prophylactic RPNI surgery.

Interventions: In Arm 1, patients underwent RPNI surgery to treat pre-existing postamputation pain. In Arm 2, patients underwent prophylactic RPNI surgery at the time of initial lower limb amputation (RPNI group) or only standard of care amputation (control group).

Main Outcome Measures: Measures included the McGill Pain Questionnaire (MPQ), Amputation Pain, Phantom Pain, Patient-Reported Outcomes Measurement Information System instruments (PROMIS), Orthotics and Prosthetics Users’ Survey (OPUS), Patient Health Questionnaire-9, and Generalized Anxiety Disorder-7 (GAD). Analyses compared standardized mean difference (effect size, d) and t-tests of baseline versus postoperative 12-month outcomes for Arm 1, and RPNI group versus control group 12-month outcomes for Arm 2er-7 (GAD).

Results: To date, 86 patients have been enrolled (Arm 1=21; Arm 2=65). In both Arms, RPNIs were associated with favorable 12-month outcomes. In Arm 1, RPNIs had the greatest effect size in improving outcomes on the MPQ (d=-0.86; p=0.186) and GAD (d=-1.27; p=0.009). In Arm 2, compared to controls, RPNI patients had the greatest effect size in improving Amputation Pain (d=-1.19; p=0.003), Phantom Pain (d=-1.15; p=0.005), and MPQ (d=-1.13; p=0.064).

Conclusions: This clinical trial supports the use of RPNI surgery to treat and prevent postamputation pain. Prophylactic RPNI surgery has significant effects in improving postamputation pain. RPNI surgery also showed improved anxiety and pain in patients with existing postamputation pain.

Level of Evidence: Level II

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PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/one-year-outcomes-following-regenerative-peripheral-nerve-interface-surgery-for-postamputation-pain-in-a-prospective-clinical-trial/