Carpal Tunnel Syndrome
Conditions
Keywords
Carpal Tunnel Syndrome
Brief summary
The purpose of this research study is to investigate if magnet therapy is effective as an alternative therapy for CTS.
Interventions
DEVICEStrong Magnetic Wristband
DEVICEWeaker Magnetic Wristband
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks | Baseline and 6 weeks | Ultrasound to assess the anatomy of the median nerve |
| Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks | Baseline and 6 weeks | Ultrasound to assess the anatomy of the median nerve |
| Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks | Baseline and 6 weeks | Ultrasound to assess the anatomy of the median nerve |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Strong Magnetic Wristband Magnetic wristband of 1,795 Gauss strength
Strong Magnetic Wristband | 9 |
| Weaker Magnetic Wristband Magnetic wristband of 5 Gauss strength.
Weaker Magnetic Wristband | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Strong Magnetic Wristband | Weaker Magnetic Wristband | Total |
|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 9.6 | 52 years STANDARD_DEVIATION 6.12 | 48.7 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment United States | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
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.
Time frame: Baseline and 6 weeks
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Strong Magnetic Wristband | Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks | 48.6 units on a scale | Standard Deviation 6.6 |
| Weaker Magnetic Wristband | Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks | 45.4 units on a scale | Standard Deviation 4.5 |
Secondary
Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks
Ultrasound to assess the anatomy of the median nerve
Time frame: Baseline and 6 weeks
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Strong Magnetic Wristband | Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks | 11.6 mm^2 | Standard Deviation 2.8 |
| Weaker Magnetic Wristband | Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks | 14.2 mm^2 | Standard Deviation 3.5 |
Secondary
Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks
Ultrasound to assess the anatomy of the median nerve
Time frame: Baseline and 6 weeks
Population: The Median Nerve Echogenicity (% hypoechoic) was the same at 89%.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Strong Magnetic Wristband | Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks | 89 percentage of hypoechoic |
| Weaker Magnetic Wristband | Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks | 89 percentage of hypoechoic |
Secondary
Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks
Ultrasound to assess the anatomy of the median nerve
Time frame: Baseline and 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Strong Magnetic Wristband | Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks | 33 percentage of Abnormal |
| Weaker Magnetic Wristband | Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks | 33 percentage of Abnormal |