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Observational Study of RPNI Surgery for Neuroma Pain After Amputation

This study is looking at two surgical methods to treat ongoing pain from neuromas (nerve endings that can cause pain) in your hand or fingers after an amputation. Researchers want to see how effective Regenerative Peripheral Nerve Interface (RPNI) surgery is compared to a standard treatment called Traction Neurectomy. You might be able to join if you are 18 or older, have had a digit or partial hand amputation, and experience discrete neuroma pain that has been confirmed by a doctor. The study will measure success by looking at changes in your pain levels and overall health using questionnaires over six months. The current status of this study is unclear, but it plans to enroll 80 participants.

Study design
This is an observational study comparing two surgical procedures. It plans to enroll 80 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after surgery to assess pain and global health.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05008185

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

Recruiting
Not specifiedAges 18+Observational
Medstar Health Research Institute
~80 participants
Updated 2024-11-29 on ClinicalTrials.gov
What's tested:Regenerative Peripheral Nerve Interface (RPNI) surgeryTraction Neurectomy

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI)
Measured over Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
+5 more outcomes measured

Conditions

Neuroma

Explore related trials

Amputation of finger, except thumbAmputation of handNeuroma

Where it's being run

2 sites across 2 states
Maryland1
Michigan1

Study leadership

  • Aviram M Giladi, MS, MD · PRINCIPAL_INVESTIGATOR · Medstar Union Memorial Hospital

Who to contact

Isaac C Fleming
[email protected]
410-554-2486
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 this trial measures

  • Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI)Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

    PROMIS Pain Interference (PROMIS-PI) scale measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities over the past 7 days answering each questions with a response of not at all, a little bit, somewhat, quite a bit, and very much with not at all being the best and very much the worst.

  • Short-form McGill Pain Questionnaire (SF-MPQ-2)Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

    theShort-form McGill Pain Questionnaire (SF-MPQ-2) measures 24 different qualities of pain and related symptoms using the intensity of pain and related symptoms felt during the past week on 0 to 10 scale, with 0 being no pain and 10 being the worst pain .

  • PROMIS Global Health (GH) v1.2Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

    The Global Health Questionnaire contains 10 questions (7 general and 3 about the last 7 days). First 7 questions use a scale of excellent, very good, good, fair, and poor, poor being the worst with excellent being the best. The other three questions use different scales such as; never rarely, sometimes, often or always with never being the best and always being the worst; as well as none, mild, moderate, severe, very severe with none being the best and very severe being the worst; finally pain rating numbered 0-10 with 0 being no pain and 10 being the worst pain imaginable.

  • Patient Health Questionnaire (PHQ-9),Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

    The PHQ-9 form is a brief, self-administered questionnaire that assesses depression symptoms over the last 2 weeks consisting of 10 questions. 9 will be answered on a scale of 0-3 with 0 being the best and 3 bing the worst. The last question will use a response of not difficult at all, somewhat difficult, very difficult, and extremely difficult with not difficult at all being the best and extremely difficult being the worst.

  • Generalized Anxiety Disorder measure (GAD-7),Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

    Generalized Anxiety Disorder measure (GAD-7) is a screening tool and severity measure for generalised anxiety disorder (GAD) over the past 2 weeks consisting of 7 questions answered on a scale of 0-3 with 0 being the best and 3 being the worst.

  • PC-PTSD-5Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

    The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) is a 5-item screening tool with 'Yes/No" answers designed to identify individuals with probable PTSD. Yes" answers represent the worst and "no" represents the best.