Cubital Tunnel Syndrome, Peroneal Nerve Entrapment
Conditions
Keywords
cubital tunnel, cubital, peroneal, nerve entrapment, nerve compression, nerve decompression, CuTS, PND, MMG, mechanomyography, cubital tunnel syndrome, peroneal nerve decompression
Brief summary
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
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
Interventions
DEVICEMechanomyography (MMG)
MMG, as described in the cohort descriptions, to be used during surgery to see if they are predictive of patient outcomes.
Sponsors
Mayo Clinic
Washington University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Questionnaire | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | 6 months | 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. |
Countries
United States
Outcome results
None listed