NCT04191538

Conditioning Electrical Stimulation to Improve Outcomes in Carpal Tunnel Syndrome

Completed Phase 1, PHASE2 Last updated 19 September 2024

What this trial tests

Phase 1, PHASE2 trial testing Conditioning electrical stimulation in Carpal Tunnel Syndrome in 56 participants. Completed in 19 April 2024.

Timeline

1 January 2020

Primary endpoint
19 April 2024

19 April 2024

Quick facts

Lead sponsor	University of Alberta
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	56
Start date	1 January 2020
Primary completion	19 April 2024
Estimated completion	19 April 2024
Sites	1 location across Canada

Drugs / interventions tested

• Conditioning electrical stimulation
• Postoperative electrical stimulation
• No electrical stimulation

Conditions studied

• Carpal Tunnel Syndrome — all drugs for Carpal Tunnel Syndrome →

Sponsor

University of Alberta

Who can join

18 and older, any sex, with Carpal Tunnel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Applications of advances in therapeutic electrical stimulation techniques and technologies in precision peripheral nerve repair: a narrative review.
   Kennedy V, Long MD, Walters J, Adewuyi AA, et al · · 2025 · cited 8× · PMID 40620882 · DOI 10.4103/atn.atn-d-24-00023
2. Investigating the Mechanism of Conditioning Versus Postoperative Electrical Stimulation to Enhance Nerve Regeneration: One Therapy, Two Distinct Effects.
   Hardy PB, Wang BY, Chan KM, Webber CA, et al · · 2025 · cited 1× · PMID 40067140 · DOI 10.1002/mus.28385
3. Conditioning Electrical Stimulation for Patients with Moderate or Severe Carpal Tunnel Syndrome: Double Blinded Randomized Controlled Trial.
   Osaki Y, Olson JL, Morhart MJ, Curran MW, et al · · 2026 · PMID 41503721 · DOI 10.1002/ana.78155