RecruitingNot Applicable

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

United States80 participantsStarted 2021-10-05

Plain-language summary

This study is being done to demonstrate the effectiveness of Regenerative Peripheral Nerve Interfaces (RPNI) surgery in treating symptomatic neuromas of the hand and digits following amputation compared to standard of care using a Prospective, Observational Trial

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI)

Timeframe: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

Short-form McGill Pain Questionnaire (SF-MPQ-2)

Timeframe: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

PROMIS Global Health (GH) v1.2

Timeframe: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

Patient Health Questionnaire (PHQ-9),

Timeframe: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

Generalized Anxiety Disorder measure (GAD-7),

Timeframe: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

PC-PTSD-5

Timeframe: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

Trial details

NCT IDNCT05008185

SponsorMedstar Health Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-08

Contact for this trial

Isaac C Fleming

410-554-2486 ike.c.fleming@medstar.net

View on ClinicalTrials.gov More Neuroma trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI)

Timeframe: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

Short-form McGill Pain Questionnaire (SF-MPQ-2)

Timeframe: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

PROMIS Global Health (GH) v1.2

Timeframe: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

Patient Health Questionnaire (PHQ-9),

Timeframe: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

Generalized Anxiety Disorder measure (GAD-7),

Timeframe: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

PC-PTSD-5

Timeframe: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months