Using electrical stimulation to improve recovery in cubital tunnel syndrome
Conditioning Electrical Stimulation Enhances Recovery Following Surgery for Severe Cubital Tunnel Syndrome: A Double-Blind Randomized Controlled Trial
NA · University of Alberta · NCT05395715
This study is testing if adding electrical stimulation to surgery can help people with severe cubital tunnel syndrome recover better and faster.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | University of Alberta (other) |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05395715 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of brief conditioning electrical stimulation to enhance nerve regeneration in patients with severe cubital tunnel syndrome. It is a double-blind, randomized, controlled study comparing outcomes in patients who undergo surgery alone versus those who receive additional electrical stimulation. The goal is to assess both physiological and functional improvements post-surgery, as previous animal studies have shown promising results for this approach. The treatment is designed to be well-tolerated and takes only an hour, making it a feasible option for patients with significant nerve injury.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with severe cubital tunnel syndrome and specific electrophysiological evidence of nerve damage.
Not a fit: Patients with concurrent nerve injuries, prior surgeries for cubital tunnel syndrome, or coexisting neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients suffering from severe cubital tunnel syndrome.
How similar studies have performed: Previous studies have shown efficacy for electrical stimulation in animal models, but this approach is relatively novel in human subjects with cubital tunnel syndrome.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Edmonton, Alberta
- University of Alberta — Edmonton, Alberta, Canada (RECRUITING)
Study contacts
- Study coordinator: Ming Chan
- Email: Ming.Chan@ualberta.ca
- Phone: (780) 492-1614
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cubital Tunnel Syndrome, Electrical Stimulation, Cubital tunnel syndrome, Nerve regeneration, Electrical stimulation, Functional outcomes, Randomized control trial, Surgery