LLLT to Reduce Low Back Pain

March 17, 2026 updated by: Ivana T Croghan, PhD, Mayo Clinic

Impact of Variable Treatment Frequencies of Low-Level Laser in 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2 treatment
Subjects will receive 2 low-level laser therapy treatments of 20 minutes for low back pain.
Device: Erchonia® Trident
Low-level laser therapy
Experimental: 4 treatment
Subjects will receive 4 low-level laser therapy treatments of 20 minutes over 2 weeks for low back pain.
Device: Erchonia® Trident
Low-level laser therapy
Experimental: 6 treatment
Subjects will receive 6 low-level laser therapy treatments of 20 minutes over 3 weeks for low back pain.
Device: Erchonia® Trident
Low-level laser therapy
Experimental: 8 treatment
Subjects will receive 8 low-level laser therapy treatments of 20 minutes over 4 weeks for low back pain.
Device: Erchonia® Trident
Low-level laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 6
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.
Baseline, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Erchonia Corporation

Investigators

  • Principal Investigator: Ivana T Croghan, PhD, Mayo Clinic
  • Principal Investigator: Ryan T Hurt, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-004998

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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