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Static Magnetic Therapy for Carpal Tunnel Syndrome (ATTRACT)

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ClinicalTrials.gov Identifier: NCT02609113
Recruitment Status : Completed
First Posted : November 20, 2015
Results First Posted : January 16, 2018
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Carpal Tunnel Syndrome
Interventions: Device: Strong Magnetic Wristband
Device: Weaker Magnetic Wristband

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Strong Magnetic Wristband

Magnetic wristband of 1,795 Gauss strength

Strong Magnetic Wristband

Weaker Magnetic Wristband

Magnetic wristband of 5 Gauss strength.

Weaker Magnetic Wristband


Participant Flow:   Overall Study
    Strong Magnetic Wristband   Weaker Magnetic Wristband
STARTED   11   11 
COMPLETED   9   9 
NOT COMPLETED   2   2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Strong Magnetic Wristband

Magnetic wristband of 1,795 Gauss strength

Strong Magnetic Wristband

Weaker Magnetic Wristband

Magnetic wristband of 5 Gauss strength.

Weaker Magnetic Wristband

Total Total of all reporting groups

Baseline Measures
   Strong Magnetic Wristband   Weaker Magnetic Wristband   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   9   18 
Age 
[Units: Years]
Median (Standard Deviation)
 46  (9.60)   52  (6.12)   48.7  (8.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9 100.0%      6  66.7%      15  83.3% 
Male      0   0.0%      3  33.3%      3  16.7% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   9   9   18 


  Outcome Measures

1.  Primary:   Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks   [ Time Frame: Baseline and 6 weeks ]

2.  Secondary:   Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks   [ Time Frame: Baseline and 6 weeks ]

3.  Secondary:   Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks   [ Time Frame: Baseline and 6 weeks ]

4.  Secondary:   Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks   [ Time Frame: Baseline and 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Vanessa Baute, MD
Organization: Wake Forest Baptist Health
phone: 336-716-8140
e-mail: vbaute@wakehealth.edu



Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02609113     History of Changes
Other Study ID Numbers: CTS-MAG-22
First Submitted: November 13, 2015
First Posted: November 20, 2015
Results First Submitted: November 10, 2017
Results First Posted: January 16, 2018
Last Update Posted: January 16, 2018