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CompletedNCT04322448Updated Sep 9, 2025

Mechanomyography for Predictor of Prognosis in CuTS and PND Patients

An observational study in Cubital Tunnel Syndrome and Peroneal Nerve Entrapment, sponsored by Washington University School of Medicine. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by Washington University School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
23
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Cubital Tunnel Syndrome
  • Peroneal Nerve Entrapment

Keywords

  • cubital tunnel
  • cubital
  • peroneal
  • nerve entrapment
  • nerve compression
  • nerve decompression
  • CuTS
  • PND
  • MMG
  • mechanomyography
  • cubital tunnel syndrome
  • peroneal nerve decompression
03

In context

Cubital Tunnel Syndrome

35 studies on the registry are indexed under Cubital Tunnel Syndrome; 7 are open to participants now.

Browse Cubital Tunnel Syndrome studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects will be recruited in the investigator's patient population.

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

Exclusion Criteria:

  • Patients under 18 years of age
  • Patients who are unable to return for follow-up evaluation.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
23 participants (actual)
Patient registry
No

Groups and cohorts

  • 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)

  • 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)

Interventions

  • DeviceMechanomyography (MMG)

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

06

What researchers measure

Primary outcomes

  1. PROMIS Questionnaire

    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.

    Time frame: 6 months

Secondary outcomes

  1. Oswestry Disability Index (ODI)

    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.

    Time frame: 6 months

07

Study locations

2 sites
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Washington University in St. Louis
    St Louis, Missouri 63110, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04322448
Lead sponsor
Washington University School of Medicine
Collaborators
Mayo Clinic
Responsible party
Wilson Z. Ray (Principal Investigator, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.) — Principal investigator
First posted
Mar 26, 2020
Start date
Aug 3, 2020
Primary completion
Jul 5, 2022
Completion
Feb 17, 2023
Last update
Sep 9, 2025

Study contacts

Wilson Z Ray, MD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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