Mechanomyography for Predictor of Prognosis in CuTS and PND Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Cubital Tunnel Syndrome; Peroneal Nerve Entrapment
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Mayo Clinic
• Investigators: Principal Investigator: Wilson Z Ray, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): July 5, 2022
• Study Completion (Actual): February 17, 2023

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: nerve decompression; PND; nerve compression; cubital tunnel; cubital tunnel syndrome; cubital; peroneal; nerve entrapment; CuTS; MMG; mechanomyography; peroneal nerve decompression
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neoplasms; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nerve Sheath Neoplasms; Mononeuropathies; Cumulative Trauma Disorders; Sprains and Strains; Ulnar Neuropathies; Ulnar Nerve Compression Syndromes; Neuroma; Nerve Compression Syndromes; Cubital Tunnel Syndrome; Peroneal Neuropathies
• Other Study ID Numbers: 201905017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No