Mechanomyography for Predictor of Prognosis in CuTS and PND Patients

Cubital Tunnel Syndrome Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04322448
• Other study ID #: 201905017
• Status: Completed
• Start date: August 3, 2020
• Est. completion date: February 17, 2023

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 17, 2023
• Est. primary completion date: July 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cubital Tunnel Syndrome
• Nerve Compression Syndromes
• Peroneal Nerve Entrapment
• Peroneal Neuropathies
• Syndrome

Intervention

Device:
• Mechanomyography (MMG)
MMG, as described in the cohort descriptions, to be used during surgery to see if they are predictive of patient outcomes.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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