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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
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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.
Visit 1
Visit 2
Visit 3 and 4 (6 week and 3 month post-op)
Visit 5 (6 months post-op)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cubital Tunnel Syndrome Patients | 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. |
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| Peroneal Nerve Decompression Patients | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanomyography (MMG) | Device | MMG, as described in the cohort descriptions, to be used during surgery to see if they are predictive of patient outcomes. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be recruited in the investigator's patient population.
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| Name | Affiliation | Role |
|---|---|---|
| Wilson Z Ray, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| Washington University in St. Louis |
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| ID | Term |
|---|---|
| D020430 | Cubital Tunnel Syndrome |
| D020427 | Peroneal Neuropathies |
| D009408 | Nerve Compression Syndromes |
| D009463 | Neuroma |
| ID | Term |
|---|---|
| D020424 | Ulnar Neuropathies |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| St Louis |
| Missouri |
| 63110 |
| United States |
| D009422 | Nervous System Diseases |
| D017769 | Ulnar Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |