Cubital Tunnel SyndromeNCT05395715
Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome
A study testing Electrical stimulation in people with Cubital Tunnel Syndrome and Electrical Stimulation, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Cubital Tunnel Syndrome, Electrical Stimulation
- What is being tested?
- Electrical stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2022to 28 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1) Patients were excluded if they had concurrent nerve injury, prior surgery for CuTS or coexisting neurologic conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2E1
Mithun Rajshekar, PhD, 7802481896, rajsheka@ualberta.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Cubital Tunnel Syndrome, Electrical Stimulation
- Being tested
- Electrical stimulation
- Keywords
- Cubital tunnel syndrome, Nerve regeneration, Electrical stimulation, Functional outcomes, Randomized control trial, Surgery, Peripheral nerve regeneration
- Medical subject headings
- Cubital Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulationProcedure or surgery
Patients with cubital tunnel syndrome will receive either surgery and sham stimulation, or conditioning electrical stimulation 7 days prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Control patients will receive cubital tunnel surgery and sham stimulation. Receives: 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 Receives: Procedure: Electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor unit number estimation
A quantitative physiological measure of the number of motor nerve fibres in the target muscle
Measured: 3 years
Secondary outcomes (2)
Key pinch strength
A functional measure of the ulnar intrinsic hand muscles using a dynamometer
Measured: 3 years
Disability of the Arm, Shoulder and Hand (DASH) Questionnaire
A questionnaire to quantify the severity of motor and sensory symptoms
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Apr 2022
- Primary completion31 Mar 2028 (estimated)
- Study completion28 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cubital Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395715
- Sponsor's protocol ID
- CuTS CES
- Status last verified
- Feb 2026
- First submitted
- 18 Apr 2022
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No