Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome

University of Alberta

Status: Enrolling

Conditions: Electrical Stimulation; Cubital Tunnel Syndrome

Treatments: Procedure: Electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05395715

CuTS CES

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Control

Active Comparator group

Description:

Control patients will receive cubital tunnel surgery and sham stimulation.

Treatment:

Procedure: Electrical stimulation

Conditioning electrical stimulation

Experimental group

Description:

Patients in the stimulation group will receive surgery as well as 1 hour of 20 Hz electrical stimulation 7 days prior to surgery

Treatment:

Procedure: Electrical stimulation