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NCT Number: NCT05008185

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

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

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Key information

Conditions

Neuroma Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nerve Sheath Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Curtis National Hand Center at Medstar Union Memorial Hospital, Baltimore, Maryland, United States

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About this study

This will be a prospective observational study that seeks to provide a comprehensive assessment of the outcomes after RPNI surgery compared to standard of care by utilizing multiple established and validated patient-reported outcomes measures, carefully tracking pre- and post-operative pain regimens, and performing functional and physiologic tests.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regenerative Peripheral Nerve Interface (RPNI) surgery

Procedure

Surgeons will perform neuroma resection and RPNI creation using a free muscle graft from the brachioradialis muscle harvested through a small separate incision

Traction Neurectomy

Procedure

Surgeons will perform neuroma resection and traction neurectomy,

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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 .

  3. PROMIS Global Health (GH) v1.2

    Time frame: Assessing 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.

  4. Patient Health Questionnaire (PHQ-9),

    Time frame: 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.

  5. Generalized Anxiety Disorder measure (GAD-7),

    Time frame: 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.

  6. PC-PTSD-5

    Time frame: Assessing 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.

Secondary outcomes

  1. PROMIS UpperExtremity (UE)

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

    PROMIS UpperExtremity (UE) is designed to evaluate upper extremity function using a scale of 1-5 with 5 being the best possible answer and 1 being the worst.

  2. Brief Michigan Hand Outcomes Questionnaire (bMHQ)

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

    The Brief Michigan Hand Outcomes Questionnaire (bMHQ) evaluates six upper extremity domains of function, activities of daily living(ADLs), aesthetics, performance,pain,and satisfaction using a scale of 1-5 with 5 being the best possible answer and 1 being the worst.

  3. Grip Strength

    Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months

    A standard dynamometer will be used to evaluate grip strength

  4. Pinch Strength -Key and Three-point

    Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months

    Evaluate key pinch (thumb to radial border of index) and three-point pinch (index, middle, and thumb tips) strength.

  5. Range of Motion

    Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months

    Evaluate active and passive range of motion of all joints in the affected extremity proximal to the amputation stump, total active and passive range of motion of all unaffected digits on the ipsilateral hand, and total active motion of fall digits and wrist on the contralateral hand as an internal control

  6. Fine Motor Function - 9-Hole Peg Test (9HPT)

    Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months

    Evaluate timed exercise during which nine relatively small pegs are picked up, one at a time, and put into nine corresponding holes. The pegs are then removed from the holes (one at a time) and placed back in the starting bin.

  7. FunctionalTask Testing - Lifting boxes

    Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months

    Evaluate whether the participant is able to perform the task, grip that was used, maximum weight used, and any compensatory findings. Subjects will be asked their pain level during each lift using a 10-point numerical scale

  8. Functional Task Testing - Carrying Boxes

    Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months

    Evaluate whether the participant is able to perform the task, grip that was used, maximum weight used, and any compensatory findings. Subjects will be asked their pain level during each lift using a 10-point numerical scale

  9. Functional Task Testing - Push/Pull sled

    Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months

    Evaluate whether the participant is able to perform the task, grip that was used, maximum weight used, and any compensatory findings. Subjects will be asked their pain level during each lift using a 10-point numerical scale

  10. Functional Task Testing - Hammer

    Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months

    Evaluate tolerance for vibration and grip to perform a hammer task using

  11. Functional Task Testing - Vice Grip

    Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months

    Evaluate vice grip Strength with all available digits using the Baltimore Therapeutic Equipment (BTE) PrimusRS work simulator.

  12. Functional Task Testing - Gear Shifting

    Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months

    Evaluate ability to grip, push and pull gear shift with all available digits using the Baltimore Therapeutic Equipment (BTE) PrimusRS work simulator

  13. Functional Task Testing - Weapon Recoil

    Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months

    Evaluate the ability to preform this simulated task using the Baltimore Therapeutic Equipment (BTE) PrimusRS work simulator

Study contacts

Contact information is provided by the study sponsor or research team.

Isaac C Fleming

CONTACT

[email protected]

410-554-2486

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Collaborators

  • United States Department of Defense
  • University of Michigan

Registry information

Official study title

Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation: A Prospective Observational Trial"

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 17, 2021
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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