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| Name | Class |
|---|---|
| Erchonia Corporation | INDUSTRY |
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The purpose of this research study is to gather information on the effectiveness of the Trident low-level laser therapy (LLLT) in combination with clinical patient education manuals to reduce lower back pain.
Patients will be administered one of 4 treatment options using the Trident LLLT. The treatment options include 2 treatments, 4 treatments, 6 treatments or 8 treatments. All patients will receive two self-help patient education manuals. Low Back Pain will be compared among all 4 options at the end of week 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 treatment | Experimental | Subjects will receive 2 low-level laser therapy treatments of 20 minutes for low back pain. |
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| 4 treatment | Experimental | Subjects will receive 4 low-level laser therapy treatments of 20 minutes over 2 weeks for low back pain. |
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| 6 treatment | Experimental | Subjects will receive 6 low-level laser therapy treatments of 20 minutes over 3 weeks for low back pain. |
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| 8 treatment | Experimental | Subjects will receive 8 low-level laser therapy treatments of 20 minutes over 4 weeks for low back pain. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erchonia® Trident | Device | Low-level laser therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Brief Pain Inventory score | The PROMIS Numeric Rating Scale v1.0 - Pain Intensity 1a will be used to measure pain intensity on a VAS scale where '0' is no pain and '10' being the worst imaginable pain. | Baseline, Week 6 |
| Change in Brief Pain Inventory score | The PROMIS Numeric Rating Scale v1.0 - Pain Intensity 1a will be used to measure pain intensity on a VAS scale where '0' is no pain and '10' being the worst imaginable pain. | Baseline, Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivana T Croghan, PhD | Mayo Clinic | Principal Investigator |
| Ryan T Hurt, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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All patients will self-select one of four treatment options: 1 week (2 treatment), 2 weeks (4 treatments), 3 weeks (6 treatments) and 4 weeks (8 treatments).
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