Cubital Tunnel Syndrome Clinical Trial
Official title:
Conditioning Electrical Stimulation Enhances Recovery Following Surgery for Severe Cubital Tunnel Syndrome: A Double-Blind Randomized Controlled Trial
NCT number | NCT05395715 |
Other study ID # | CuTS CES |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2022 |
Est. completion date | June 28, 2026 |
Cubital tunnel syndrome is the second most common compression neuropathy. In severe cases, functional recovery, even with surgery, is often poor. Therefore, alternative adjunct treatments capable of increasing the speed of nerve regeneration are much needed.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 28, 2026 |
Est. primary completion date | March 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility | Inclusion Criteria: 1. Patients aged >18 yr, 2. If signs and symptoms of severe CuTS (ie, McGowan-Goldberg grade 3) were observed, 3. If needle EMG examination showed evidence of chronic motor axonal loss and reduced recruitment in the ulnar-innervated intrinsic hand muscles, and 4. If electrophysiologic evidence of severe motor axonal loss with motor unit number estimation (MUNE) greater than 2 standard deviations below the normative mean. Exclusion Criteria: 1) Patients were excluded if they had concurrent nerve injury, prior surgery for CuTS or coexisting neurologic conditions |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Motor unit number estimation | A quantitative physiological measure of the number of motor nerve fibres in the target muscle | 3 years | |
Secondary | Key pinch strength | A functional measure of the ulnar intrinsic hand muscles using a dynamometer | 3 years | |
Secondary | Disability of the Arm, Shoulder and Hand (DASH) Questionnaire | A questionnaire to quantify the severity of motor and sensory symptoms | 3 years |
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