NCT02609113CompletedNot Applicable
A Double Blinded, Prospective, Randomized Trial of Static Magnetic Therapy for Carpal Tunnel Syndrome (CTS)
Wake Forest University Health Sciences1 site in 1 country22 target enrollmentStarted: August 1, 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks
Study Overview
Brief Summary
The purpose of this research study is to investigate if magnet therapy is effective as an alternative therapy for CTS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Strong Magnetic Wristband
Active Comparator
Magnetic wristband of 1,795 Gauss strength
Intervention: Strong Magnetic Wristband (Device)
Weaker Magnetic Wristband
Placebo Comparator
Magnetic wristband of 5 Gauss strength.
Intervention: Weaker Magnetic Wristband (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Study of Efficacy and Safety of Secukinumab in Psoriatic Arthritis and Axial Spondyloarthritis Patients With Active Enthesitis Including One Achilles Tendon SiteAxial SpondyloarthritisPsoriatic ArthritisEnthesitisNCT02771210Novartis Pharmaceuticals204
Unknown
Phase 4
Study on Magnetic Field Therapy to Improve Quality of Sleep and Reduction of Chronic Spine PainBack PainNeck PainSleep Initiation and Maintenance DisordersNCT00445133Weintraub, Michael I., MD, FACP, FAAN80
Completed
Not Applicable
Trial to Evaluate Efficacy of Magnetic Resonant Therapy (MRT) in PTSDStress Disorders, Post-TraumaticNCT02268084Wave Neuroscience96
Not yet recruiting
Not Applicable
Evaluation of the Efficacy and Safety of Magnetically-controlled Capsule Gastroscopy for Postoperative Assessment in Elderly Patients and Patients With Underlying DiseasesEvaluation,Efficacy,SafetyNCT06029608Shanghai Jiao Tong University School of Medicine120
Completed
Phase 3
Berlin Magnetic Seizure Therapy Depression Trial 01Bipolar DepressionUnipolar DepressionNCT00914680Charite University, Berlin, Germany32