Health TrialsbyHealthPanel

Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome

ConditionsCubital Tunnel SyndromeElectrical Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorUniversity of Alberta

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Electrical stimulation

    Procedure/Surgery

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: Conditioning electrical stimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Motor unit number estimation

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

Time frame
3 years

Secondary outcomes

1

Key pinch strength

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

Time frame
3 years
2

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

A questionnaire to quantify the severity of motor and sensory symptoms

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Source ClinicalTrials.gov
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