Using low-level laser therapy to alleviate low back pain
Impact of Variable Treatment Frequencies of Low-Level Laser in Reduce Low-Back Pain
This study is testing if low-level laser therapy, along with self-help manuals, can help people with lower back pain feel better after six weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06007976 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness of Trident low-level laser therapy (LLLT) combined with patient education manuals in reducing lower back pain. Participants will receive one of four treatment regimens consisting of 2, 4, 6, or 8 LLLT sessions, along with two self-help manuals. The study aims to compare pain levels among the different treatment options at the end of a six-week period. The primary focus is on patients reporting significant pain in their lower back.
Who should consider this trial
Good fit: Ideal candidates are individuals experiencing lower back pain with a pain intensity of 4 or higher on the Visual Analogue scale.
Not a fit: Patients who have recently used pain medications or participated in pain treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive treatment option for individuals suffering from low back pain.
How similar studies have performed: Previous studies have shown promise with low-level laser therapy for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Ivana T Croghan, PhD — Mayo Clinic
- Study coordinator: Shawn Fokken
- Email: Fokken.Shawn@mayo.edu
- Phone: 507-293-2740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.