Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrical stimulation.
- Who it may be relevant to
- Registry conditions: Cubital Tunnel Syndrome, Electrical Stimulation. Basic parameters: 18 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Conditioning Electrical Stimulation Enhances Recovery Following Surgery for Severe Cubital Tunnel Syndrome: A Double-Blind Randomized Controlled Trial
Overview
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.
Interventions
- Procedure Electrical stimulation
Patients with cubital tunnel syndrome will receive either surgery and sham stimulation, or conditioning electrical stimulation 7 days prior to surgery
Primary outcome measures
- Motor unit number estimation [Time frame: 3 years]
Secondary outcome measures (2)
- Key pinch strength [Time frame: 3 years]
- Disability of the Arm, Shoulder and Hand (DASH) Questionnaire [Time frame: 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- University of Alberta — Edmonton
Identifiers
NCT: NCT05395715 · CuTS CES