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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 : September 10, 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
Enrollment 22

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Strong Magnetic Wristband Weaker Magnetic Wristband
Hide Arm/Group Description

Magnetic wristband of 1,795 Gauss strength

Strong Magnetic Wristband

Magnetic wristband of 5 Gauss strength.

Weaker Magnetic Wristband

Period Title: Overall Study
Started 11 11
Completed 9 9
Not Completed 2 2
Arm/Group Title Strong Magnetic Wristband Weaker Magnetic Wristband Total
Hide Arm/Group Description

Magnetic wristband of 1,795 Gauss strength

Strong Magnetic Wristband

Magnetic wristband of 5 Gauss strength.

Weaker Magnetic Wristband

Total of all reporting groups
Overall Number of Baseline Participants 9 9 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 18 participants
46  (9.60) 52  (6.12) 48.7  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
Female
9
 100.0%
6
  66.7%
15
  83.3%
Male
0
   0.0%
3
  33.3%
3
  16.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 9 participants 9 participants 18 participants
9
 100.0%
9
 100.0%
18
 100.0%
1.Primary Outcome
Title Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Strong Magnetic Wristband Weaker Magnetic Wristband
Hide Arm/Group Description:

Magnetic wristband of 1,795 Gauss strength

Strong Magnetic Wristband

Magnetic wristband of 5 Gauss strength.

Weaker Magnetic Wristband

Overall Number of Participants Analyzed 9 9
Median (Standard Deviation)
Unit of Measure: units on a scale
48.6  (6.6) 45.4  (4.5)
2.Secondary Outcome
Title Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks
Hide Description Ultrasound to assess the anatomy of the median nerve
Time Frame Baseline and 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Median Nerve Echogenicity (% hypoechoic) was the same at 89%.
Arm/Group Title Strong Magnetic Wristband Weaker Magnetic Wristband
Hide Arm/Group Description:

Magnetic wristband of 1,795 Gauss strength

Strong Magnetic Wristband

Magnetic wristband of 5 Gauss strength.

Weaker Magnetic Wristband

Overall Number of Participants Analyzed 9 9
Measure Type: Number
Unit of Measure: percentage of hypoechoic
89 89
3.Secondary Outcome
Title Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks
Hide Description Ultrasound to assess the anatomy of the median nerve
Time Frame Baseline and 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Strong Magnetic Wristband Weaker Magnetic Wristband
Hide Arm/Group Description:

Magnetic wristband of 1,795 Gauss strength

Strong Magnetic Wristband

Magnetic wristband of 5 Gauss strength.

Weaker Magnetic Wristband

Overall Number of Participants Analyzed 9 9
Median (Standard Deviation)
Unit of Measure: mm^2
11.6  (2.8) 14.2  (3.5)
4.Secondary Outcome
Title Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks
Hide Description Ultrasound to assess the anatomy of the median nerve
Time Frame Baseline and 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Strong Magnetic Wristband Weaker Magnetic Wristband
Hide Arm/Group Description:

Magnetic wristband of 1,795 Gauss strength

Strong Magnetic Wristband

Magnetic wristband of 5 Gauss strength.

Weaker Magnetic Wristband

Overall Number of Participants Analyzed 9 9
Measure Type: Number
Unit of Measure: percentage of Abnormal
33 33
Time Frame Baseline to 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Strong Magnetic Wristband Weaker Magnetic Wristband
Hide Arm/Group Description

Magnetic wristband of 1,795 Gauss strength

Strong Magnetic Wristband

Magnetic wristband of 5 Gauss strength.

Weaker Magnetic Wristband

All-Cause Mortality
Strong Magnetic Wristband Weaker Magnetic Wristband
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Strong Magnetic Wristband Weaker Magnetic Wristband
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Strong Magnetic Wristband Weaker Magnetic Wristband
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%) 
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.
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
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: September 10, 2018