Static Magnetic Therapy for Carpal Tunnel Syndrome
ATTRACT
A Double Blinded, Prospective, Randomized Trial of Static Magnetic Therapy for Carpal Tunnel Syndrome (CTS)
1 other identifier
interventional
22
1 country
1
Brief Summary
The purpose of this research study is to investigate if magnet therapy is effective as an alternative therapy for CTS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 13, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2016
CompletedResults Posted
Study results publicly available
January 16, 2018
CompletedSeptember 10, 2018
August 1, 2018
1.2 years
November 13, 2015
November 10, 2017
August 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
Strong Magnetic Wristband
ACTIVE COMPARATORMagnetic wristband of 1,795 Gauss strength
Weaker Magnetic Wristband
PLACEBO COMPARATORMagnetic wristband of 5 Gauss strength.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of mild to moderate Carpal Tunnel Syndrome by history, clinical exam and Electromyography (EMG) study.
- ≥ 18 years
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limitations of the study that could contribute to the lack of measurable change include a short duration, small sample size, and inefficacy of magnet therapy in relation to neurodiagnostic measures.
Results Point of Contact
- Title
- Vanessa Baute, MD
- Organization
- Wake Forest Baptist Health
Study Officials
- PRINCIPAL INVESTIGATOR
Vanessa Baute, MD
Wake ForestUBMC
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2015
First Posted
November 20, 2015
Study Start
August 1, 2015
Primary Completion
October 21, 2016
Study Completion
October 21, 2016
Last Updated
September 10, 2018
Results First Posted
January 16, 2018
Record last verified: 2018-08