Mechanomyography for Predictor of Prognosis in CuTS and PND Patients

Completed

• Conditions: Cubital Tunnel Syndrome; Peroneal Nerve Entrapment
• Interventions: Device: Mechanomyography (MMG)

• Registration Number: NCT04322448
• Lead Sponsor: Washington University School of Medicine

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-26
• Study Start: 2020-08-03
• Primary Completion: 2022-07-05
• Study Completion: 2023-02-17
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Patients who have a diagnosis of Cubital Tunnel Syndrome or Compressive Peroneal Nerve Neuropathy and will be undergoing a decompressive surgery.

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Exclusion Criteria

• Patients under 18 years of age
• Patients who are unable to return for follow-up evaluation.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cubital Tunnel Syndrome Patients	Mechanomyography (MMG)	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.
Peroneal Nerve Decompression Patients	Mechanomyography (MMG)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States