Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05395715
• Other study ID #: CuTS CES
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: June 28, 2026

Study information

• Verified date: April 2024
• Source: University of Alberta
• Contact: Ming Chan
• Phone: (780) 492-1614
• Email: Ming.Chan[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The effect of brief conditioning electrical stimulation on nerve regeneration has been showed to be efficacy in animal studies. In this double-blind, randomized, controlled study, the investigators will compare the physiological and functional improvements post surgery compared with the controls who received surgery alone. Because electrical stimulation is reasonably well-tolerated and the treatment only takes an hour, it is a potentially feasible clinical tool for patients with severe nerve injury.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cubital Tunnel Syndrome
• Electrical Stimulation
• Syndrome

Intervention

Procedure:
• Electrical stimulation
Patients with cubital tunnel syndrome will receive either surgery and sham stimulation, or conditioning electrical stimulation 7 days prior to surgery

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

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