Neuroma
Conditions
Keywords
Neuroma, Neuroma Pain, Finger Amputation, Hand Amputation
Brief 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
Detailed description
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.
Interventions
Surgeons will perform neuroma resection and RPNI creation using a free muscle graft from the brachioradialis muscle harvested through a small separate incision
PROCEDURETraction Neurectomy
Surgeons will perform neuroma resection and traction neurectomy,
Sponsors
United States Department of Defense
University of Michigan
Medstar Health Research Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) v1.2 | 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. |
| 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-5 | 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
| Measure | Time frame | Description |
|---|---|---|
| FunctionalTask Testing - Lifting boxes | 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 |
| Functional Task Testing - Carrying Boxes | 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 |
| Functional Task Testing - Push/Pull sled | 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 |
| PROMIS UpperExtremity (UE) | 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. |
| Functional Task Testing - Vice Grip | 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. |
| Functional Task Testing - Gear Shifting | 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 |
| Functional Task Testing - Weapon Recoil | 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 |
| Functional Task Testing - Hammer | Assessing change from Baseline to 1 month, 3 months and 6 months | Evaluate tolerance for vibration and grip to perform a hammer task using |
| Brief Michigan Hand Outcomes Questionnaire (bMHQ) | 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. |
| Grip Strength | Assessing change from Baseline to 1 month, 3 months and 6 months | A standard dynamometer will be used to evaluate grip strength |
| Pinch Strength -Key and Three-point | 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. |
| Range of Motion | 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 |
| Fine Motor Function - 9-Hole Peg Test (9HPT) | 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. |
Countries
United States
Contacts
Primary ContactIsaac C Fleming
Outcome results
None listed