Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cubital Tunnel Syndrome, Electrical Stimulation

Intervention / Treatment
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* Procedure: Electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged >18 yr, If signs and symptoms of severe CuTS (ie, McGowan-Goldberg grade 3) were observed, If needle EMG examination showed evidence of chronic motor axonal loss and reduced recruitment in the ulnar-innervated intrinsic hand muscles, and 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind randomized controlled study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Control patients will receive cubital tunnel surgery and sham stimulation. | Procedure: Electrical stimulation<br>* Patients with cubital tunnel syndrome will receive either surgery and sham stimulation, or conditioning electrical stimulation 7 days prior to surgery<br>|
| Experimental: Conditioning electrical stimulation<br>Patients in the stimulation group will receive surgery as well as 1 hour of 20 Hz electrical stimulation 7 days prior to surgery | Procedure: Electrical stimulation<br>* Patients with cubital tunnel syndrome will receive either surgery and sham stimulation, or conditioning electrical stimulation 7 days prior to surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor unit number estimation | A quantitative physiological measure of the number of motor nerve fibres in the target muscle | 3 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cubital tunnel syndrome, Nerve regeneration, Electrical stimulation, Functional outcomes, Randomized control trial, Surgery, Peripheral nerve regeneration