Mechanomyography for Predictor of Prognosis in CuTS and PND Patients

Study Overview
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Brief Summary
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The study will be a non-blinded two cohort design consisting only of symptomatic patients with CuTS or compressive peroneal neuropathy or in need of peroneal nerve decompression. The first cohort will be - patients with CuTS. Evaluation of each CuTS patient will include assessment by the treating surgeon and a certified hand therapist. Patients who have clinical examination and history consistent with a diagnosis of CuTS based on subjective and functional assessment outlined below will be consented to this study. The second cohort will be patients in need PND for compressive neuropathy of peroneal nerve. PND patients will be evaluated by clinical exam and have imaging with high resolution ultrasound or MRI negative for mass lesion.

Detailed Description
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Visit 1 Exam and discussion with surgeon Exam and testing with Occupational Hand Therapist (Standard of Care) as described above. (CuTS cohort) Diagnostic studies (EMG/NCT) (Standard of Care) Questionnaires - PROMIS and ODI Visit 2 Standard of Care surgery During surgery, the surgeon will perform an MMG immediately pre-decompression and immediately post-decompression of the nerve. This will entail placing a sensor and probe on the nerve that will be decompressed. Visit 3 and 4 (6 week and 3 month post-op) Clinical Exam by Surgeon Exam and testing with Occupational Therapist (Standard of Care) as described above. (CuTS cohort) Questionnaires - PROMIS and ODI Visit 5 (6 months post-op) Clinical Exam by Surgeon Exam and testing with Occupational Therapist (Standard of Care) as described above. (CuTS cohort) Questionnaires - PROMIS and ODI Evaluation of MMG parameters

Official Title
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Identification and Validation of Non-invasive Mechanomyography as a Valuable Predictor of Clinical Course and Long-term Prognosis for Cubital Tunnel Syndrome and Peroneal Nerve Decompression Patients

Conditions
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Cubital Tunnel Syndrome, Peroneal Nerve Entrapment

Intervention / Treatment
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* Device: Mechanomyography (MMG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have a diagnosis of Cubital Tunnel Syndrome or Compressive Peroneal Nerve Neuropathy and will be undergoing a decompressive surgery. Exclusion Criteria: Patients under 18 years of age Patients who are unable to return for follow-up evaluation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cubital Tunnel Syndrome Patients<br>Cubital Tunnel Syndrome patients. Patients will undergo standard of care exams and surgery. During surgery, the surgeon will apply the mechanomyography (MMG) to the targeted nerve immediately prior and post decompression. Subjects will be followed until they are 6 months postop. | Device: Mechanomyography (MMG)<br>* MMG, as described in the cohort descriptions, to be used during surgery to see if they are predictive of patient outcomes.<br>|
| Peroneal Nerve Decompression Patients<br>Patients with compressive peroneal nerve neuropathy and will undergo a Peroneal Nerve Decompression (PND). Patients will undergo standard of care exams and surgery. During surgery, the surgeon will apply the mechanomyography (MMG) to the targeted nerve immediately prior and post decompression. Subjects will be followed until they are 6 months postop. | Device: Mechanomyography (MMG)<br>* MMG, as described in the cohort descriptions, to be used during surgery to see if they are predictive of patient outcomes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Questionnaire | PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Scores range from 0-50 with a higher indicating a better outcome. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) | 10 question tool that researchers and disability evaluators use to measure a patient's permanent functional disability. Score ranges from 0-100. Lower scores indicate a better outcome. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PND, cubital tunnel, cubital, peroneal, nerve entrapment, nerve compression, nerve decompression, CuTS, MMG, mechanomyography, cubital tunnel syndrome, peroneal nerve decompression