Cubital Tunnel SyndromeNCT04322448
Mechanomyography for Predictor of Prognosis in CuTS and PND Patients
An observational study of Cubital Tunnel Syndrome and Peroneal Nerve Entrapment, run by Washington University School of Medicine at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cubital Tunnel Syndrome, Peroneal Nerve Entrapment
- What is being tested?
- Mechanomyography (MMG)
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Aug 2020to 17 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited in the investigator's patient population.
Who may be able to join
- Patients who have a diagnosis of Cubital Tunnel Syndrome or Compressive Peroneal Nerve Neuropathy and will be undergoing a decompressive surgery.
Who cannot join
- Patients under 18 years of age
- Patients who are unable to return for follow-up evaluation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55905
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
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
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
- Conditions
- Cubital Tunnel Syndrome, Peroneal Nerve Entrapment
- Being tested
- Mechanomyography (MMG)
- Keywords
- cubital tunnel, cubital, peroneal, nerve entrapment, nerve compression, nerve decompression, CuTS, PND, MMG, mechanomyography, cubital tunnel syndrome, peroneal nerve decompression
- Medical subject headings
- Cubital Tunnel Syndrome, Peroneal Neuropathies, Nerve Compression Syndromes, Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanomyography (MMG)Device
MMG, as described in the cohort descriptions, to be used during surgery to see if they are predictive of patient outcomes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Mechanomyography (MMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start3 Aug 2020
- Primary completion5 Jul 2022
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cubital Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Principal investigator, Wilson Z. Ray, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Investigators
- Wilson Z Ray, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322448
- Sponsor's protocol ID
- 201905017
- Status last verified
- Nov 2024
- First submitted
- 27 Jan 2020
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04322448
- Acronym / sponsor ID
- 201905017
- Conditions
- Cubital Tunnel Syndrome, Peroneal Nerve Entrapment
- Keywords
- cubital tunnel, cubital, peroneal, nerve entrapment, nerve compression, nerve decompression, CuTS, PND
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cubital Tunnel Syndrome Patients | – | Device: Mechanomyography (MMG)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. |
| Peroneal Nerve Decompression Patients | – | Device: Mechanomyography (MMG)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited in the investigator's patient population.
Key inclusion criteria (1 listed)
- Patients who have a diagnosis of Cubital Tunnel Syndrome or Compressive Peroneal Nerve Neuropathy and will be undergoing a decompressive surgery.
Key exclusion criteria (2 listed)
- Patients under 18 years of age
- Patients who are unable to return for follow-up evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanomyography (MMG)MMG, as described in the cohort descriptions, to be used during surgery to see if they are predictive of patient outcomes. | Device | Cubital Tunnel Syndrome Patients, Peroneal Nerve Decompression Patients |
Primary outcome
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.
1 secondary outcome
Oswestry Disability Index (ODI)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilson Z Ray, MD principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cubital Tunnel Syndrome and Peroneal Nerve Entrapment, run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.