A Double Blinded, Prospective, Randomized Trial of Static Magnetic Therapy for Carpal Tunnel Syndrome (CTS)

Wake Forest University Health Sciences1 site in 1 country22 target enrollmentAugust 2015

ConditionsCarpal Tunnel Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Carpal Tunnel Syndrome
Sponsor: Wake Forest University Health Sciences
Enrollment: 22
Locations: 1
Primary Endpoint: Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research study is to investigate if magnet therapy is effective as an alternative therapy for CTS.

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

October 21, 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wake Forest University Health Sciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of mild to moderate Carpal Tunnel Syndrome by history, clinical exam and Electromyography (EMG) study.
•≥ 18 years

Exclusion Criteria

•Current use of magnets as therapy for Carpal Tunnel Syndrome
•Known allergy to silicone
•Unwillingness to wear wristband for 6 weeks
•Patients who have devices that may be affected by exposure to magnets such as vagal nerve stimulator, pacemaker or insulin pump.

Outcomes

Primary Outcomes

Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks

Time Frame: Baseline and 6 weeks

Patient reported outcome measure of symptom severity and functional status. Is made of the Symptom severity scale (11 items) score 1 to 5 where lower numbers denotes better outcomes; and the Functional status scale (8 items) score 1 to 5 where lower numbers denotes better outcomes. Total score 1- 95 where lower numbers denotes better outcomes.

Secondary Outcomes

Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks(Baseline and 6 weeks)
Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks(Baseline and 6 weeks)
Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks(Baseline and 6 weeks)