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Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome

Conditioning Electrical Stimulation Enhances Recovery Following Surgery for Severe Cubital Tunnel Syndrome: A Double-Blind Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05395715
Enrollment
30
Registered
2022-05-27
Start date
2022-04-01
Completion date
2028-06-28
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cubital Tunnel Syndrome, Electrical Stimulation

Keywords

Cubital tunnel syndrome, Nerve regeneration, Electrical stimulation, Functional outcomes, Randomized control trial, Surgery, Peripheral nerve regeneration

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.

Interventions

PROCEDUREElectrical stimulation

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

Sponsors

University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Intervention model description

Double-blind randomized controlled study

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Motor unit number estimation3 yearsA quantitative physiological measure of the number of motor nerve fibres in the target muscle

Secondary

MeasureTime frameDescription
Key pinch strength3 yearsA functional measure of the ulnar intrinsic hand muscles using a dynamometer
Disability of the Arm, Shoulder and Hand (DASH) Questionnaire3 yearsA questionnaire to quantify the severity of motor and sensory symptoms

Countries

Canada

Contacts

CONTACTMing Chan
Ming.Chan@ualberta.ca(780) 492-1614

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026