Clinical Trials

Inclusion Criteria: 

• Individual 18 years of age or older.
• Reporting a primary pain point in lower back.
• Pain intensity reported at baseline must be 4 and above on the VAS 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 (outside of NSAID) or participated in a pain treatment within three days of study enrollment.
• Have an implanted device (including lap band) in the targeted area of LLLT.
• 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 LLLT 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 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.

Eligibility last updated 5/12/23. Questions regarding updates should be directed to the study team contact.