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Mechanomyography for Predictor of Prognosis in CuTS and PND Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04322448
Recruitment Status : Active, not recruiting
First Posted : March 26, 2020
Last Update Posted : February 21, 2022
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Wilson Z. Ray, Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment
Cubital Tunnel Syndrome Peroneal Nerve Entrapment 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

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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : August 3, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited in the investigator's patient population.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322448


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Mayo Clinic
Investigators
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Principal Investigator: Wilson Z Ray, MD Washington University School of Medicine
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Responsible Party: Wilson Z. Ray, Principal Investigator, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04322448    
Other Study ID Numbers: 201905017
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: February 21, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Wilson Z. Ray, Washington University School of Medicine:
cubital tunnel
cubital
peroneal
nerve entrapment
nerve compression
nerve decompression
CuTS
PND
MMG
mechanomyography
cubital tunnel syndrome
peroneal nerve decompression
Additional relevant MeSH terms:
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Nerve Compression Syndromes
Cubital Tunnel Syndrome
Peroneal Neuropathies
Syndrome
Disease
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Ulnar Neuropathies
Mononeuropathies
Ulnar Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries