Mechanomyography for Predictor of Prognosis in CuTS and PND Patients

Sponsor

Washington University School of Medicine (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04322448

Collaborator

Mayo Clinic (Other)

Enrollment

Locations

33.9

Anticipated Duration (Months)

11.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cubital Tunnel Syndrome Peroneal Nerve Entrapment	Device: Mechanomyography (MMG)

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

Study Design

Study Type:

Observational

Actual Enrollment :

23 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 3, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Mechanomyography (MMG) MMG, as described in the cohort descriptions, to be used during surgery to see if they are predictive of patient outcomes.
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.	Device: Mechanomyography (MMG) MMG, as described in the cohort descriptions, to be used during surgery to see if they are predictive of patient outcomes.

Arm

Intervention/Treatment

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.

Device: Mechanomyography (MMG)

MMG, as described in the cohort descriptions, to be used during surgery to see if they are predictive of patient outcomes.

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.

Device: Mechanomyography (MMG)

MMG, as described in the cohort descriptions, to be used during surgery to see if they are predictive of patient outcomes.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.