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The purpose of this research study is to investigate if magnet therapy is effective as an alternative therapy for CTS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strong Magnetic Wristband | Active Comparator | Magnetic wristband of 1,795 Gauss strength |
|
| Weaker Magnetic Wristband | Placebo Comparator | Magnetic wristband of 5 Gauss strength. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strong Magnetic Wristband | Device |
| ||
| Weaker Magnetic Wristband |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks | Ultrasound to assess the anatomy of the median nerve | Baseline and 6 weeks |
| Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa Baute, MD | Wake ForestUBMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Strong Magnetic Wristband | Magnetic wristband of 1,795 Gauss strength Strong Magnetic Wristband |
| FG001 | Weaker Magnetic Wristband | Magnetic wristband of 5 Gauss strength. Weaker Magnetic Wristband |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Strong Magnetic Wristband | Magnetic wristband of 1,795 Gauss strength Strong Magnetic Wristband |
| BG001 | Weaker Magnetic Wristband | Magnetic wristband of 5 Gauss strength. Weaker Magnetic Wristband |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Standard Deviation | units on a scale | Baseline and 6 weeks |
|
Baseline to 6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Strong Magnetic Wristband | Magnetic wristband of 1,795 Gauss strength Strong Magnetic Wristband |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanessa Baute, MD | Wake Forest Baptist Health | 336-716-8140 | vbaute@wakehealth.edu |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| Device |
|
Ultrasound to assess the anatomy of the median nerve
| Baseline and 6 weeks |
| Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks | Ultrasound to assess the anatomy of the median nerve | Baseline and 6 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks | Ultrasound to assess the anatomy of the median nerve | The Median Nerve Echogenicity (% hypoechoic) was the same at 89%. | Posted | Number | percentage of hypoechoic | Baseline and 6 weeks |
|
|
|
| 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 | Posted | Median | Standard Deviation | mm^2 | Baseline and 6 weeks |
|
|
|
| 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 | Posted | Number | percentage of Abnormal | Baseline and 6 weeks |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Weaker Magnetic Wristband | Magnetic wristband of 5 Gauss strength. Weaker Magnetic Wristband | 0 | 11 | 0 | 11 |
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| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |