Variable Treatment Frequencies of Low-Level Laser in Reduce Low-Back Pain

Overview

About this study

The purpose of this study is to obtain preliminary evidence regarding the efficacy of low level laser therapy  (LLLT) treatments for reducing pain when supplemented with 2 patient manuals focused on pain.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ivana Croghan, Ph.D.

Open for enrollment

Contact information:

Shawn Fokken CCRP

(507) 293-2740

GIMResearchStudies@mayo.edu

More information

Publications

Publications are currently not available