Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome

NCT05395715 | Recruiting

• 1 other identifier: CuTS CES
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cubital Tunnel Syndrome; Electrical Stimulation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Motor unit number estimation

  A quantitative physiological measure of the number of motor nerve fibres in the target muscle

  3 years

Secondary Outcomes (2)

• Key pinch strength

  3 years

• Disability of the Arm, Shoulder and Hand (DASH) Questionnaire

  3 years

Study Arms (2)

Control

ACTIVE COMPARATOR

Control patients will receive cubital tunnel surgery and sham stimulation.

Procedure: Electrical stimulation

Conditioning electrical stimulation

EXPERIMENTAL

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

Interventions

Electrical stimulation 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; Control

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) Patients were excluded if they had concurrent nerve injury, prior surgery for CuTS or coexisting neurologic conditions

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

RECRUITING

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Ulnar Neuropathies; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Ulnar Nerve Compression Syndromes; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Central Study Contacts

Ming Chan

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind randomized controlled study

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: May 27, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): June 28, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)