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OpenTrials
Active, Not Recruiting

NCT Number: NCT06007976

LLLT to Reduce Low Back Pain

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erchonia® Trident

Device

Low-level laser therapy

Primary outcomes

  1. Change in Brief Pain Inventory score

    Time frame: Baseline, Week 6

    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.

  2. Change in Brief Pain Inventory score

    Time frame: Baseline, Week 24

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Erchonia Corporation

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 23, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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