LLLT to Reduce Low Back Pain

Not Applicable

Recruiting

• Conditions: Low Back Pain
• Interventions: Device: Erchonia® Trident

• Registration Number: NCT06007976
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-17
• Study First Posted: 2023-08-23
• Study Start: 2024-02-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6 treatment	Erchonia® Trident	Subjects will receive 6 low-level laser therapy treatments of 20 minutes over 3 weeks for low back pain.
8 treatment	Erchonia® Trident	Subjects will receive 8 low-level laser therapy treatments of 20 minutes over 4 weeks for low back pain.
2 treatment	Erchonia® Trident	Subjects will receive 2 low-level laser therapy treatments of 20 minutes for low back pain.
4 treatment	Erchonia® Trident	Subjects will receive 4 low-level laser therapy treatments of 20 minutes over 2 weeks for low back pain.

Primary Outcome Measures

Name	Time	Method
Change in Brief Pain Inventory score	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States