Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2026-06-28

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.

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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.

Conditions

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Cubital Tunnel Syndrome Electrical Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind randomized controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

Control patients will receive cubital tunnel surgery and sham stimulation.

Group Type ACTIVE_COMPARATOR

Electrical stimulation

Intervention Type PROCEDURE

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

Conditioning 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

Group Type EXPERIMENTAL

Electrical stimulation

Intervention Type PROCEDURE

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

Interventions

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Electrical stimulation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.