Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- Reporting a primary pain point in lower back.
- Pain intensity reported at baseline must be 4 and above on the Visual Analogue scale (PROMIS Numeric Rating Scale).
- Individual able to participate fully in all aspects of the study and have understood and signed study informed consent.
Exclusion Criteria:
- Have used pain medications or participated in a pain treatment within three days of study enrollment.
- Have an implanted device (including lap band) in the targeted area of Low Level Laser Treatment.
- Have used an investigational drug within 30 days of study enrollment.
- Reports being currently pregnant, lactating, or are of child-bearing potential or are likely to become pregnant during the low level laser treatment phase and are unwilling to use a reliable form of contraception. Acceptable forms of contraception include: Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants; Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm); Intrauterine device (IUD); Total hysterectomy or tubal ligation; Abstinence (no sex).
- Have a history of any major cardiovascular events including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease.
- Have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, metabolic disease (such as uncontrolled diabetes type 2), active cancer, actively receiving l treatment for cancer or within 1 year of cancer remission.
- Surgical intervention for pain within 1 month prior to enrollment.
- Active infection, wound or other external trauma to the areas to be treated with the laser
- Known photosensitivity disorder.
- Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.