Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome

Not Applicable

Recruiting

• Conditions: Cubital Tunnel Syndrome; Electrical Stimulation
• Interventions: Procedure: Electrical stimulation

• Registration Number: NCT05395715
• Lead Sponsor: University of Alberta

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26
• Primary Completion: 2026-03-31
• Study Completion: 2026-06-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Electrical stimulation	Control patients will receive cubital tunnel surgery and sham stimulation.
Conditioning electrical stimulation	Electrical stimulation	Patients in the stimulation group will receive surgery as well as 1 hour of 20 Hz electrical stimulation 7 days prior to surgery

Primary Outcome Measures

Name	Time	Method
Motor unit number estimation	3 years	A quantitative physiological measure of the number of motor nerve fibres in the target muscle

Secondary Outcome Measures

Name	Time	Method
Key pinch strength	3 years	A functional measure of the ulnar intrinsic hand muscles using a dynamometer
Disability of the Arm, Shoulder and Hand (DASH) Questionnaire	3 years	A questionnaire to quantify the severity of motor and sensory symptoms

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada