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NCT Number: NCT04322448

Mechanomyography for Predictor of Prognosis in CuTS and PND Patients

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.

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Key information

Conditions

Cubital Tunnel Syndrome Cumulative Trauma Disorders Mononeuropathies Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nerve Compression Syndromes Nerve Sheath Neoplasms Nervous System Diseases Neuroma Neuromuscular Diseases Peripheral Nervous System Diseases Peroneal Nerve Entrapment Peroneal Neuropathies Sprains and Strains Ulnar Nerve Compression Syndromes Ulnar Neuropathies Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Rochester, Minnesota, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mechanomyography (MMG)

Device

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

Primary outcomes

  1. PROMIS Questionnaire

    Time frame: 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 outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Mayo Clinic

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 26, 2020
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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