- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02609113
Static Magnetic Therapy for Carpal Tunnel Syndrome (ATTRACT)
August 10, 2018 updated by: Wake Forest University Health Sciences
A Double Blinded, Prospective, Randomized Trial of Static Magnetic Therapy for Carpal Tunnel Syndrome (CTS)
The purpose of this research study is to investigate if magnet therapy is effective as an alternative therapy for CTS.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Strong Magnetic Wristband
Magnetic wristband of 1,795 Gauss strength
|
|
Placebo Comparator: Weaker Magnetic Wristband
Magnetic wristband of 5 Gauss strength.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks
Time Frame: Baseline and 6 weeks
|
Ultrasound to assess the anatomy of the median nerve
|
Baseline and 6 weeks
|
Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks
Time Frame: Baseline and 6 weeks
|
Ultrasound to assess the anatomy of the median nerve
|
Baseline and 6 weeks
|
Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks
Time Frame: Baseline and 6 weeks
|
Ultrasound to assess the anatomy of the median nerve
|
Baseline and 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Vanessa Baute, MD, Wake ForestUBMC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
October 21, 2016
Study Completion (Actual)
October 21, 2016
Study Registration Dates
First Submitted
November 13, 2015
First Submitted That Met QC Criteria
November 17, 2015
First Posted (Estimate)
November 20, 2015
Study Record Updates
Last Update Posted (Actual)
September 10, 2018
Last Update Submitted That Met QC Criteria
August 10, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTS-MAG-22
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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