Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation

Launched by MEDSTAR HEALTH RESEARCH INSTITUTE · Aug 9, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical approach called Regenerative Peripheral Nerve Interfaces (RPNI) to help treat painful neuromas in the hand and fingers after amputation. Neuromas are nerve growths that can cause significant pain, and this trial aims to see if RPNI surgery is more effective than standard treatment options. The trial is currently looking for participants aged 18 and older who have experienced an amputation of one or more fingers or part of their hand and have nerve pain that can be confirmed through medical evaluations.

To join the study, participants must have already tried standard therapies, including seeing a hand therapist for a minimum of six weeks to help manage their pain. However, those who have previously had surgery for neuromas, have other serious injuries affecting the same arm, are pregnant, or are unable to give consent cannot participate. If eligible, participants will receive the RPNI surgery and then be monitored to see how well it works in reducing their pain. This trial represents a hopeful step toward improving care for individuals suffering from neuroma pain after an amputation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years or older
• • History of unilateral digit, multiple digit, or partial hand amputation
• • Discrete neuroma pain on clinical exam
• • Following standard of care (SOC), confirmation through a local block and/or ultrasound imaging will be performed if indicated
• • Must be seen by a hand therapist for at least 6-week trial of desensitization therapy
• Exclusion Criteria:
• • Patients with previous surgical treatment for symptomatic neuromas of the digits or hand
• • Patients with other major injuries more proximal in the ipsilateral extremity that cause chronic pain or functional loss
• • women pregnant at time of enrollment
• • prisoners
• • adults who are unable to consent