LLLT to Reduce Low Back Pain

NCT ID: NCT06007976

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-16
• Study Completion Date: 2026-12-31

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2 treatment

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

Group Type: EXPERIMENTAL

Erchonia® Trident

Intervention Type: DEVICE

Low-level laser therapy

4 treatment

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

Group Type: EXPERIMENTAL

Erchonia® Trident

Intervention Type: DEVICE

Low-level laser therapy

6 treatment

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

Group Type: EXPERIMENTAL

Erchonia® Trident

Intervention Type: DEVICE

Low-level laser therapy

8 treatment

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

Group Type: EXPERIMENTAL

Erchonia® Trident

Intervention Type: DEVICE

Low-level laser therapy

Interventions

Erchonia® Trident

Low-level laser therapy

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erchonia Corporation

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ivana T Croghan, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivana T Croghan, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Ryan T Hurt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shawn Fokken

Role: CONTACT

Fokken.Shawn@mayo.edu

507-293-2740

Facility Contacts

Shawn Fokken, CCRP

Role: primary

GIMRESEARCHSTUDIES@mayo.edu

507-293-2790

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

23-004998

Identifier Type: -

Identifier Source: org_study_id