Static Magnetic Therapy for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

— ATTRACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609113
• Other study ID #: CTS-MAG-22
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: October 21, 2016

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 21, 2016
• Est. primary completion date: October 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• Strong Magnetic Wristband

• Weaker Magnetic Wristband

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 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.	Baseline and 6 weeks
Secondary	Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks	Ultrasound to assess the anatomy of the median nerve	Baseline and 6 weeks
Secondary	Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks	Ultrasound to assess the anatomy of the median nerve	Baseline and 6 weeks
Secondary	Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks	Ultrasound to assess the anatomy of the median nerve	Baseline and 6 weeks