NCT04322448

Mechanomyography for Predictor of Prognosis in CuTS and PND Patients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cubital Tunnel Syndrome
• Peroneal Nerve Entrapment

Interventions

Type	Name	Description
DEVICE	Mechanomyography (MMG)	MMG, as described in the cohort descriptions, to be used during surgery to see if they are predictive of patient outcomes.

Timeline

• Start date: 2020-08-03
• Primary completion: 2022-07-05
• Completion: 2023-02-17
• First posted: 2020-03-26
• Last updated: 2025-09-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study