Back to resultsStatic Magnetic Therapy for Carpal Tunnel Syndrome (ATTRACT)
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strong Magnetic Wristband
Weaker Magnetic Wristband
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Syndrome
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.
Sites / Locations
- Wake Forest Baptist Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Strong Magnetic Wristband
Weaker Magnetic Wristband
Arm Description
Magnetic wristband of 1,795 Gauss strength
Magnetic wristband of 5 Gauss strength.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 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
Ultrasound to assess the anatomy of the median nerve
Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks
Ultrasound to assess the anatomy of the median nerve
Full Information
NCT ID
NCT02609113
First Posted
November 13, 2015
Last Updated
August 10, 2018
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02609113
Brief Title
Static Magnetic Therapy for Carpal Tunnel Syndrome
Acronym
ATTRACT
Official Title
A Double Blinded, Prospective, Randomized Trial of Static Magnetic Therapy for Carpal Tunnel Syndrome (CTS)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 21, 2016 (Actual)
Study Completion Date
October 21, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to investigate if magnet therapy is effective as an alternative therapy for CTS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Strong Magnetic Wristband
Arm Type
Active Comparator
Arm Description
Magnetic wristband of 1,795 Gauss strength
Arm Title
Weaker Magnetic Wristband
Arm Type
Placebo Comparator
Arm Description
Magnetic wristband of 5 Gauss strength.
Intervention Type
Device
Intervention Name(s)
Strong Magnetic Wristband
Intervention Type
Device
Intervention Name(s)
Weaker Magnetic Wristband
Primary Outcome Measure Information:
Title
Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks
Description
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.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks
Description
Ultrasound to assess the anatomy of the median nerve
Time Frame
Baseline and 6 weeks
Title
Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks
Description
Ultrasound to assess the anatomy of the median nerve
Time Frame
Baseline and 6 weeks
Title
Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks
Description
Ultrasound to assess the anatomy of the median nerve
Time Frame
Baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Baute, MD
Organizational Affiliation
Wake ForestUBMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Static Magnetic Therapy for Carpal Tunnel Syndrome
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