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

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.

Study Overview

• Status: Recruiting
• Conditions: Electrical Stimulation; Cubital Tunnel Syndrome
• Intervention / Treatment: Procedure: Electrical stimulation

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming Chan; Phone Number: (780) 492-1614; Email: Ming.Chan@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2E1
      • Recruiting
      • University of Alberta
      • Contact: Mithun Rajshekar, PhD; Phone Number: 7802481896; Email: rajsheka@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Control patients will receive cubital tunnel surgery and sham stimulation.	Procedure: Electrical stimulation; Patients with cubital tunnel syndrome will receive either surgery and sham stimulation, or conditioning electrical stimulation 7 days prior to surgery
Experimental: 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	Procedure: Electrical stimulation; Patients with cubital tunnel syndrome will receive either surgery and sham stimulation, or conditioning electrical stimulation 7 days prior to surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): June 28, 2026

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Electrical stimulation; Randomized control trial; Functional outcomes; Nerve regeneration; Cubital tunnel syndrome; Peripheral nerve regeneration
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Ulnar Nerve Compression Syndromes; Ulnar Neuropathies; Syndrome; Cubital Tunnel Syndrome
• Other Study ID Numbers: CuTS CES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No