Clinical trial NCT06007976: LLLT to Reduce Low Back Pain
Official title: Impact of Variable Treatment Frequencies of Low-Level Laser in Reduce Low-Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: laser
LLLT
back pain
pain
low back pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Erchonia Corporation
First posted: 2023-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Brief Pain Inventory score
timeFrame: Baseline, Week 6
measure: Change in Brief Pain Inventory score
timeFrame: Baseline, Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ivana T Croghan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Ryan T Hurt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: