Back to resultsConditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome
Primary Purpose
Cubital Tunnel Syndrome, Electrical Stimulation
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Cubital Tunnel Syndrome focused on measuring Cubital tunnel syndrome, Nerve regeneration, Electrical stimulation, Functional outcomes, Randomized control trial, Surgery, Peripheral nerve regeneration
Eligibility Criteria
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
Sites / Locations
- University of AlbertaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Conditioning electrical stimulation
Arm Description
Control patients will receive cubital tunnel surgery and sham stimulation.
Patients in the stimulation group will receive surgery as well as 1 hour of 20 Hz electrical stimulation 7 days prior to surgery
Outcomes
Primary Outcome Measures
Motor unit number estimation
A quantitative physiological measure of the number of motor nerve fibres in the target muscle
Secondary Outcome Measures
Key pinch strength
A functional measure of the ulnar intrinsic hand muscles using a dynamometer
Disability of the Arm, Shoulder and Hand (DASH) Questionnaire
A questionnaire to quantify the severity of motor and sensory symptoms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05395715
Brief Title
Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome
Official Title
Conditioning Electrical Stimulation Enhances Recovery Following Surgery for Severe Cubital Tunnel Syndrome: A Double-Blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
June 28, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cubital Tunnel Syndrome, Electrical Stimulation
Keywords
Cubital tunnel syndrome, Nerve regeneration, Electrical stimulation, Functional outcomes, Randomized control trial, Surgery, Peripheral nerve regeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blind randomized controlled study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control patients will receive cubital tunnel surgery and sham stimulation.
Arm Title
Conditioning electrical stimulation
Arm Type
Experimental
Arm Description
Patients in the stimulation group will receive surgery as well as 1 hour of 20 Hz electrical stimulation 7 days prior to surgery
Intervention Type
Procedure
Intervention Name(s)
Electrical stimulation
Intervention Description
Patients with cubital tunnel syndrome will receive either surgery and sham stimulation, or conditioning electrical stimulation 7 days prior to surgery
Primary Outcome Measure Information:
Title
Motor unit number estimation
Description
A quantitative physiological measure of the number of motor nerve fibres in the target muscle
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Key pinch strength
Description
A functional measure of the ulnar intrinsic hand muscles using a dynamometer
Time Frame
3 years
Title
Disability of the Arm, Shoulder and Hand (DASH) Questionnaire
Description
A questionnaire to quantify the severity of motor and sensory symptoms
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Chan
Phone
(780) 492-1614
Email
Ming.Chan@ualberta.ca
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mithun Rajshekar, PhD
Phone
7802481896
Email
rajsheka@ualberta.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome
We'll reach out to this number within 24 hrs