Preoperative Electrical Stimulation for Carpal Tunnel Syndrome

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Alberta

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Carpal tunnel syndrome is common, identified in 3% of the general population. Symptoms including numbness and pain are due to compression of the median nerve as it travels through a tunnel entering the wrist and can result in weakened grip strength and poor dexterity. Despite surgical release, nerve damage due to chronic compression often cannot be completely reversed, with resulting sensorimotor deficits. Postoperative electrical stimulation (ES) has been well-reported to improve nerve regeneration and is currently standard of practice at our institution. Investigators of this study have recently shown in an animal model that by changing the timing of the ES from postoperative to preoperative, this "conditioning" electrical stimulation (CES) significantly improves nerve regeneration. Patients with severe carpal tunnel syndrome will be identified in plastic surgery clinics. Patients who consent to participating will undergo baseline testing including nerve conduction studies, sensory evaluation, motor testing, and patient-reported outcomes. Participants will be randomized to three groups: i) CES, ii) postoperative ES, and iii) no ES. CES will be delivered in clinic by placing a percutaneous needle alongside the median nerve, and stimulation will be delivered for one hour, with patient comfort dictating the voltage of stimulation. At the completion of one hour, the needle will be removed, and a standard carpal tunnel release will be performed by their plastic surgeon 4-7 days later. Patients will the second cohort will undergo postoperative ES immediately following their carpal tunnel release, using the same stimulation parameters as CES. The third cohort will receive only carpal tunnel release without stimulation.In all patients, sensory and motor reinnervation, using the same testing modalities as preoperative assessment, will be evaluated at 3, 6, and 12 months post-operative.

Research Team

Eligibility Criteria

This trial is for individuals with severe carpal tunnel syndrome who haven't improved with non-surgical treatments and require surgery. They must have significant nerve damage as shown by tests, but can't have any other preexisting nerve conditions.

Inclusion Criteria

My condition hasn't improved with basic treatments and needs surgery.

You have severe carpal tunnel syndrome as determined by a nerve conduction test.

Exclusion Criteria

You already have nerve problems.

Treatment Details

Interventions

Conditioning Electrical Stimulation (Behavioural Intervention)
No Electrical Stimulation (Procedure)
Postoperative Electrical Stimulation (Behavioural Intervention)

Trial OverviewThe study examines if electrical stimulation before or after carpal tunnel surgery helps better than no stimulation at all. Participants will be randomly placed into three groups to receive either preoperative, postoperative stimulation, or no stimulation.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Conditioning electrical stimulationExperimental Treatment1 Intervention

Patients will receive percutaneous electrical stimulation one week prior to carpal tunnel release. They will receive sham stimulation immediately after surgery to ensure blinding.

Group II: Postoperative electrical stimulationActive Control1 Intervention

Patients will receive electrical stimulation immediately following carpal tunnel release, per out previous studies. They will receive sham stimulation 1 week prior to surgery to ensure blinding.

Group III: No electrical stimulationPlacebo Group1 Intervention

Patients will not receive electrical stimulation. They will receive electrical stimulation before and after surgery to ensure blinding.

Conditioning Electrical Stimulation is already approved in Canada for the following indications: