LLLT to Reduce Low Back Pain

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06007976

Collaborator

Erchonia Corporation (Industry)

Enrollment

Location

Arms

25.5

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Device: Erchonia® Trident	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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).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).

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 15, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Change in Brief Pain Inventory score [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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.