Static Magnetic Therapy for Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Device: Strong Magnetic Wristband; Device: Weaker Magnetic Wristband

• Registration Number: NCT02609113
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-11-13
• Study First Submitted QC: 2015-11-17
• Study First Posted: 2015-11-20
• Primary Completion: 2016-10-21
• Study Completion: 2016-10-21
• Results First Submitted: 2017-11-10
• Results First Submitted QC: 2017-12-15
• Results First Posted: 2018-01-16
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-10
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Strong Magnetic Wristband	Strong Magnetic Wristband	Magnetic wristband of 1,795 Gauss strength
Weaker Magnetic Wristband	Weaker Magnetic Wristband	Magnetic wristband of 5 Gauss strength.

Primary Outcome Measures

Name	Time	Method
Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks	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 Outcome Measures

Name	Time	Method
Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks	Baseline and 6 weeks	Ultrasound to assess the anatomy of the median nerve
Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks	Baseline and 6 weeks	Ultrasound to assess the anatomy of the median nerve
Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks	Baseline and 6 weeks	Ultrasound to assess the anatomy of the median nerve

Trial Locations

Locations (1)

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States