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Preoperative Electrical Stimulation for Carpal Tunnel Syndrome

Phase 1 & 2

Recruiting

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Failed conservative treatment (requires surgical intervention)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up compare with baseline function to that at 12 months

Awards & highlights

Study Summary

This trial is testing whether electrical stimulation before carpal tunnel surgery can improve nerve regeneration and reduce symptoms better than electrical stimulation after surgery or no electrical stimulation.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Electrical stimulation may cause discomfort or pain where the needle is inserted alongside the median nerve. The voltage of the stimulation will be adjusted based on patient comfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ compare with baseline function to that at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~compare with baseline function to that at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and compare with baseline function to that at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Motor reinnervation

Patient-reported outcome

Sensory reinnervation

Trial Design

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

888 Previous Clinical Trials

384,898 Total Patients Enrolled

2 Trials studying Carpal Tunnel Syndrome

40 Patients Enrolled for Carpal Tunnel Syndrome

Media Library

Conditioning Electrical Stimulation Clinical Trial Eligibility Overview. Trial Name: NCT04191538 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the numerical participation rate of this research project?

"Affirmative. The information published on clinicaltrials.gov reveals that this medical test, which was initially posted in January 1st 2020, is currently recruiting participants. There is a requirement for 60 volunteers from one healthcare facility to take part in the trial."

Answered by AI

Are there still vacancies for participants in this clinical trial?

"Indeed, the clinical trial is actively seeking participants. Clinicaltrials.gov reveals that the study was posted on January 1st 2020 and last updated July 12th 2022. The research necessitates 60 individuals at one particular medical centre for enrolment."

Answered by AI

Recent research and studies

Experimental NeurologyJournal

Brief Post-surgical Electrical Stimulation Accelerates Axon Regeneration and Muscle Reinnervation Without Affecting the Functional Measures in Carpal Tunnel Syndrome Patients

Gordon, Tessa, Nasim Amirjani, David C. Edwards, and K. Ming Chan. 2010. “Brief Post-surgical Electrical Stimulation Accelerates Axon Regeneration and Muscle Reinnervation Without Affecting the Functional Measures in Carpal Tunnel Syndrome Patients”. Experimental Neurology. Elsevier BV. doi:10.1016/j.expneurol.2009.09.020.

Experimental NeurologyJournal

Electrical Stimulation as a Conditioning Strategy for Promoting and Accelerating Peripheral Nerve Regeneration

Senger, J.L.B., V.M.K. Verge, H.S.J. Macandili, J.L. Olson, K.M. Chan, and C.A. Webber. 2018. “Electrical Stimulation as a Conditioning Strategy for Promoting and Accelerating Peripheral Nerve Regeneration”. Experimental Neurology. Elsevier BV. doi:10.1016/j.expneurol.2017.12.013.

Experimental NeurologyJournal

Brief Post-surgical Electrical Stimulation Accelerates Axon Regeneration and Muscle Reinnervation Without Affecting the Functional Measures in Carpal Tunnel Syndrome Patients

clinicaltrials.govStudy

Conditioning Electrical Stimulation to Improve Outcomes in Carpal Tunnel Syndrome