Mechanomyography for Predictor of Prognosis in CuTS and PND Patients

NCT ID: NCT04322448

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-03

Study Completion Date

2023-02-17

Brief Summary

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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.

Detailed Description

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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

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Cubital Tunnel Syndrome Peroneal Nerve Entrapment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Mechanomyography (MMG)

Intervention Type DEVICE

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.

Mechanomyography (MMG)

Intervention Type DEVICE

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

Interventions

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Mechanomyography (MMG)

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Wilson Z. Ray

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wilson Z Ray, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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201905017

Identifier Type: -

Identifier Source: org_study_id

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