LLLT to Reduce Low Back Pain

NCT06007976 | Active Not Recruiting FDA Device

• 1 other identifier: 23-004998
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

laser; LLLT; back pain; pain; low back pain

Outcome Measures

Primary Outcomes (2)

• Change in Brief Pain Inventory score

  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

  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

Study Arms (4)

2 treatment

EXPERIMENTAL

Subjects will receive 2 low-level laser therapy treatments of 20 minutes for low back pain.

Device: Erchonia® Trident

4 treatment

EXPERIMENTAL

Subjects will receive 4 low-level laser therapy treatments of 20 minutes over 2 weeks for low back pain.

Device: Erchonia® Trident

6 treatment

EXPERIMENTAL

Subjects will receive 6 low-level laser therapy treatments of 20 minutes over 3 weeks for low back pain.

Device: Erchonia® Trident

8 treatment

EXPERIMENTAL

Subjects will receive 8 low-level laser therapy treatments of 20 minutes over 4 weeks for low back pain.

Device: Erchonia® Trident

Interventions

Erchonia® Trident DEVICE

Low-level laser therapy

2 treatment; 4 treatment; 6 treatment; 8 treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Erchonia Corporation: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Low Back Pain; Back Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ivana T Croghan, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Ryan T Hurt, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All patients will self-select one of four treatment options: 1 week (2 treatment), 2 weeks (4 treatments), 3 weeks (6 treatments) and 4 weeks (8 treatments).

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: February 16, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)