Actively Recruiting

Phase Not Applicable
Age: 18Years - 79Years
All Genders
Healthy Volunteers
ID05395715

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

Led by University of Alberta · Updated on 2026-02-09

30

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Cubital tunnel syndrome is a common nerve compression condition that can have poor recovery outcomes even after surgery. Researchers are evaluating whether brief conditioning electrical stimulation before surgery can improve nerve healing and function in people with severe cubital tunnel syndrome. This study is a double-blind, randomized, controlled trial conducted to compare the effects of electrical stimulation plus surgery versus surgery alone on nerve recovery. Participants will be randomly assigned to one of two groups. One group will receive standard cubital tunnel surgery with sham stimulation, while the other group will receive surgery plus one hour of 20 Hz electrical stimulation applied seven days before surgery. Electrical stimulation is given as a short, well-tolerated procedure that may help speed nerve regeneration. During the three-year follow-up, participants will be assessed for nerve function using motor unit number estimation as the primary outcome. Secondary measures include grip strength and disability questionnaires focusing on arm, shoulder, and hand function. Researchers will monitor physiological and functional improvements over time to evaluate the potential benefit of the electrical stimulation treatment.

CONDITIONS

Brief Title

Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome

Who Can Participate

Age: 18Years - 79Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged over 18 years
  • Signs and symptoms of severe cubital tunnel syndrome (McGowan-Goldberg grade 3)
  • Needle EMG showing chronic motor axonal loss and reduced recruitment in ulnar-innervated hand muscles
  • Electrophysiologic evidence of severe motor axonal loss with motor unit number estimation 2 standard deviations below norm
Not Eligible

You will not qualify if you...

  • Concurrent nerve injury
  • Prior surgery for cubital tunnel syndrome
  • Coexisting neurological conditions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - 1 week

Participants receive either 1 hour of 20 Hz conditioning electrical stimulation or sham stimulation 7 days prior to surgery.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to hospital discharge

Participants undergo cubital tunnel surgery followed by immediate recovery care.

1 surgery visit plus immediate post-operative care visits

Post-operative Follow-up

Duration - Up to 3 years

Participants are monitored for physiological and functional recovery after surgery over the long term.

Periodic visits over 3 years

Trial Site Locations

Total: 1 location

1

University of Alberta

Edmonton, Alberta, Canada, T6G 2E1

Actively Recruiting

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Research Team

M

Ming Chan

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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