Amputation Neuroma
Conditions
Brief summary
The Regenerative Peripheral Nerve Interface (RPNI) is a novel strategy to prevent neuroma formation in transected peripheral nerves. The RPNI consists of a residual peripheral nerve that is implanted into a free skeletal muscle graft either at the time of limb amputation or after excision of a terminal neuroma bulb. The sprouting axons of the nerve readily reinnervate the free muscle graft, thereby greatly reducing the chance of neuroma formation. This investigation has a prospective cohort study design involving major lower limb amputees drawn from both the University of Michigan Health Systems and VA Health System of Ann Arbor. To objectively evaluate the effect of RPNI surgery on patients' perception of pain and to measure other health-related quality of life metrics relating to neuroma pain, this clinical trial will utilize specific, validated patient-reported outcomes measures (PROMs) to assess targeted domains in patients with major limb amputation. These survey instruments will determine: 1) patterns of pain medication use, including the use of opioids, 2) functional status and use of a prosthetic device, 3) changes in neuroma pain quality, 4) limitations in activities of daily living due to neuroma pain, 5) depression and anxiety relating to neuroma pain.
Interventions
PROCEDUREAmputation with Regenerative Peripheral Nerve Interfaces (RPNI)
Free-muscle graft over cut nerve ends for treatment of neuromas at site of an amputation.
OTHERAmputation Without RPNI
Standard of care for lower-extremity amputation
Sponsors
University of Michigan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Major lower limb amputation (chronic pain treatment group only) * Symptomatic residual limb neuroma (chronic pain treatment group only) * Undergoing a major lower limb amputation (prophylactic pain treatment group only)
Exclusion criteria
* History of chronic amputation-related pain (prophylactic pain treatment group only) * History of regenerative peripheral nerve interface (RPNI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pain Intensity | Up to 12 months postoperatively | The PROMIS was a system of standardized, scientifically validated questions used to measure a patient's physical, mental, and social health status. The PROMIS pain intensity short form had 3 questions ranging from 0 \[had no pain\] to 5 \[very severe\]. The PROMIS was scored by summing the values of the responses within each short form. The raw score was converted to a standardized T-score using specific scoring tables found in the instrument's scoring manual. |
| Short-form McGill Pain Questionnaire 2 (SF-MPQ-2) | Up to 12 months postoperatively | The SF-MPQ-2 was a pain assessment tool that measured both neuropathic and non-neuropathic pain. It used 22 descriptors, grouped into four subscales (continuous, intermittent, neuropathic, and affective) along with a Present Pain Intensity (PPI) scale. The descriptors and PPI all used a Likert scale that ranged from 0 (none) to 10 (worst possible). The SF-MPQ-2 was scored by calculating the average ratings for each of the four subscales and the total pain score and averaging all 22 item ratings, resulting in a score ranging from 0 (none) to 10 (worst possible). |
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference | Up to 12 months postoperatively | The PROMIS was a system of standardized, scientifically validated questions used to measure a patient's physical, mental, and social health status. The PROMIS pain interference short form had 6 questions ranging from 1 \[not at all\] to 5 \[very much\]. The PROMIS was scored by summing the values of the responses within each short form. The raw score was converted to a standardized T-score using specific scoring tables found in the instrument's scoring manual. |
| PROMIS - Neuropathic Pain Quality | Up to 12 months postoperatively | The PROMIS was a system of standardized, scientifically validated questions used to measure a patient's physical, mental, and social health status. The PROMIS neuropathic pain quality short form had 5 questions ranging from 1 \[not at all\] to 5 \[very much\]. The PROMIS was scored by summing the values of the responses within each short form. The raw score was converted to a standardized T-score using specific scoring tables found in the instrument's scoring manual. |
| Orthotics and Prosthetics Users Survey (OPUS) | Up to 12 months postoperatively | The OPUS was a self-report questionnaire consisting of five modules. It can be used for prosthetic and orthotic programs for quality assessment, to maintain awareness of improvement in activities, to evaluate changes in patient's functional status and quality of life, and to assess satisfaction with devices and services. This study used the Functional Status Measure module, which was a 20-question survey that used a Likert scale ranging from 1 (very easy) to 5 (cannot do this activity). |
| Pain Cognition Scale (PCS) | Up to 12 months postoperatively | The PCS evaluated the relationship between thoughts and pain. The PCS was a 13-question survey that used a Likert scale ranging from 0 (not at all) to 4 (all the time). Total score ranged from 0 (no pain catastrophizing) to 52 (highest level of pain catastrophizing), with a score of 30 indicating a clinically high level of pain catastrophizing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General Anxiety Disorder-7 (GAD-7) - anxiety | Up to 12 months postoperatively | The GAD-7 was a seven-item questionnaire used to screen for and measure the severity of generalized anxiety disorder (GAD). It asked about symptoms like feeling nervous, worrying too much, and trouble relaxing, with responses scored from 0 to 3 for each of the seven questions. The total score, ranging from 0 to 21, is interpreted to indicate the level of anxiety: 0-4 (minimal), 5-9 (mild), 10-14 (moderate), and 15-21 (severe). |
| Fibromyalgia Survey Questionnaire (FSQ) | Up to 12 months postoperatively | The FSQ was a tool used to assess the key symptoms of fibromyalgia by evaluating widespread pain and the severity of other somatic symptoms. It was comprised of two tools, the widespread pain index (WPI) subsection and the symptom severity score (SSS), which were summed to get a result. The WPI asked participants to mark off from a list of 19 potential pain locations on a body diagram. which were summed. The total score ranged from 0 to 19. The SSS evaluated the severity of three major symptoms and the severity of other somatic symptoms. The SSS consisted of 6 questions with a total score ranging from 0 to 12. The total range of both tools combined was 0 to 31, with a total score of ≥13 supporting a diagnosis of fibromyalgia. |
| Patient Health Questionnaire-9 (PHQ-9) - Depression | Up to 12 months postoperatively | The PHQ-9 was a nine-question self-report questionnaire used to screen for depression, diagnose its severity, and monitor treatment response. Each of the nine questions was scored on a four-point scale from 0 (Not at all) to 3 (Nearly every day). The PHQ-9 asked about the frequency of specific depressive symptoms over the past two weeks, with a total score ranging from 0 to 27, with scores below 5 indicating no depression and scores above 20 indicating severe depression. |
Countries
United States
Outcome results
None listed