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NCT Number: NCT05395715

Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome

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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Key information

Conditions

Cubital Tunnel Syndrome Cumulative Trauma Disorders Electrical Stimulation Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Ulnar Nerve Compression Syndromes Ulnar Neuropathies Wounds and Injuries

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location status: Recruiting

Location contact

Mithun Rajshekar, PhD

CONTACT

[email protected]

7802481896

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Electrical stimulation

Procedure

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

Primary outcomes

  1. Motor unit number estimation

    Time frame: 3 years

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

Secondary outcomes

  1. Key pinch strength

    Time frame: 3 years

    A functional measure of the ulnar intrinsic hand muscles using a dynamometer

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

    Time frame: 3 years

    A questionnaire to quantify the severity of motor and sensory symptoms

Study contacts

Contact information is provided by the study sponsor or research team.

Ming Chan

CONTACT

[email protected]

(780) 492-1614

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
May 27, 2022
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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