Laser Therapy for Lower Back Pain

Overseen By Shawn Fokken

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Pain medications

Disqualifiers: Pregnancy, Cardiovascular events, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2-4 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, you must stop taking pain medications at least three days before joining the study.

What data supports the effectiveness of the treatment for lower back pain?

Research shows that low-level laser therapy (LLLT), also known as cold laser therapy, can help reduce pain and inflammation. It has been used successfully for various types of pain, including chronic pain and osteoarthritis, and has shown benefits in treating musculoskeletal disorders like back pain. ^{1 2 3 4 5}

Is laser therapy safe for humans?

Low-level laser therapy (LLLT), also known as cold laser therapy, has been used safely in various medical fields for decades, including dentistry and pain management. It is a non-invasive treatment that has shown benefits like pain relief and accelerated healing, with no significant safety concerns reported in the studies reviewed. ^{1 2 3 6 7}

How is the treatment Erchonia® Trident different from other treatments for lower back pain?

Erchonia® Trident uses low-level laser therapy (LLLT), which is a non-drug approach that involves using light to trigger beneficial chemical changes in cells, potentially reducing pain and inflammation without medication. ^{1 2 4 8 9}

Research Team

Ryan T Hurt, MD, PhD

Principal Investigator

Mayo Clinic

Ivana Croghan, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults with lower back pain of intensity 4 or higher on the Visual Analogue scale. Participants must be able to engage fully in the study and have signed informed consent. Excluded are those who've used pain treatments recently, have implants in the treatment area, pregnant women not using contraception, anyone with major cardiovascular events, unstable diseases, recent surgery for pain, infections at treatment sites, photosensitivity disorders or other conditions as determined by the investigator.

Inclusion Criteria

My main pain is in my lower back.

Your pain level must be 4 or higher on the 1-10 scale before starting the study.

I can participate in all study activities and have signed the consent form.

Exclusion Criteria

I do not have any unstable or serious health conditions, including uncontrolled diabetes or active cancer.

I have a condition that makes my skin unusually sensitive to sunlight.

Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low-level laser therapy treatments of varying frequencies (2, 4, 6, or 8 treatments) over 2 to 4 weeks

2-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

Treatment Details

Interventions

• Erchonia® Trident

Trial Overview The study tests how effective Erchonia® Trident low-level laser therapy (LLLT), combined with patient education manuals, is at reducing lower back pain. It aims to gather data on this non-invasive treatment's success rate in alleviating discomfort associated with lower back issues.

Participant Groups

Group I: 8 treatment Experimental Treatment 1 Intervention

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

Group II: 6 treatment Experimental Treatment 1 Intervention

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

Group III: 4 treatment Experimental Treatment 1 Intervention

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

Group IV: 2 treatment Experimental Treatment 1 Intervention

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

Erchonia® Trident is already approved in United States, European Union for the following indications:

Approved in United States as Erchonia Trident for:

• Neck Pain
• Shoulder Pain
• Low Back Pain
• Nociceptive Musculoskeletal Pain
• Plantar Fasciitis
• Postoperative Pain
• Acne
• Laser Assisted Liposuction
• Non-Invasive Body Contouring
• Onychmycosis

Approved in European Union as Erchonia Trident for:

• Neck Pain
• Shoulder Pain
• Low Back Pain
• Nociceptive Musculoskeletal Pain
• Plantar Fasciitis
• Postoperative Pain
• Acne

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Erchonia Corporation

Industry Sponsor

Trials

45

Recruited

2,100+

Findings from Research

In a study of 36 patients undergoing root canal retreatment, low-level laser therapy (LLLT) significantly reduced postoperative pain in the first four days compared to a placebo, indicating its efficacy as a pain management technique.

Patients receiving LLLT required fewer analgesics than those in the placebo group, and no pain was reported during the LLLT application, suggesting it is a safe and effective nonpharmacologic option for managing pain after dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Low-level Laser Therapy on Postoperative Pain after Root Canal Retreatment: A Preliminary Placebo-controlled, Triple-blind, Randomized Clinical Trial. Arslan, H., Doğanay, E., Karataş, E., et al.[2018]

Low-level laser therapy (LLLT) effectively reduces pain and promotes healing by using coherent light in the 600 to 1000 nm wavelength range, which triggers biochemical changes in cells and has been supported by numerous clinical and experimental studies.

LLLT has shown significant analgesic and anti-inflammatory effects, making it a promising complementary treatment option for managing symptoms in patients with osteoarthritis and chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. Dima, R., Tieppo Francio, V., Towery, C., et al.[2019]

Low-level laser therapy (LLLT) is an emerging technique in dentistry that has been used effectively in various medical fields for decades, providing benefits like faster wound healing and pain relief.

Understanding the mechanisms of LLLT and how to optimize its use is crucial for achieving the best treatment outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level laser therapy in dentistry. Sun, G., Tunér, J.[2022]

Low-level laser therapy (LLLT) showed statistically significant but clinically unimportant pain relief in some patients with non-specific low-back pain, based on a review of seven randomized controlled trials involving 168 participants.

While LLLT did not demonstrate superior effectiveness compared to exercise alone in reducing pain or disability, it was associated with a lower relapse rate at six months, and no side effects were reported, indicating a potential safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low level laser therapy for nonspecific low-back pain. Yousefi-Nooraie, R., Schonstein, E., Heidari, K., et al.[2022]

Low level laser therapy (LLLT) significantly improved chronic neck pain in 26 patients with cervical disk hernia, as measured by a visual analogue scale (VAS) after a treatment regimen of twice a week for 4 weeks (p<0.001).

While LLLT effectively reduced pain, it did not significantly improve cervical spine range of motion, highlighting the importance of combining treatment with postural training to maintain benefits and prevent future pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low level laser therapy for patients with cervical disk hernia. Takahashi, H., Okuni, I., Ushigome, N., et al.[2021]

Low-level laser therapy (LLLT) significantly reduces pain intensity in both acute and chronic neck pain, with a notable reduction of 19.86 mm on a 100 mm visual analogue scale across 16 trials involving 820 patients.

The pain relief from LLLT can last up to 22 weeks after treatment, and side effects are mild and comparable to those of a placebo, indicating a safe and effective non-invasive treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Chow, RT., Johnson, MI., Lopes-Martins, RA., et al.[2022]

In a study involving 88 osteoarthritis patients, low level laser therapy (LLLT) did not show significant improvements in pain relief, morning stiffness, or overall functional status compared to sham treatment.

However, LLLT did result in a notable improvement in carpometacarpal opposition and grip strength, suggesting some specific benefits despite overall lack of efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial on low level laser therapy (LLLT) in the treatment of osteoarthritis (OA) of the hand. Brosseau, L., Wells, G., Marchand, S., et al.[2022]

Low-level laser therapy (LLLT) showed significant short-term and intermediate-term pain relief in patients with sub-acute and chronic low-back pain compared to sham therapy, based on three studies involving 168 participants.

No side effects were reported from LLLT, but the evidence is insufficient to make definitive conclusions about its long-term effectiveness or its impact on disability and range of motion, highlighting the need for more rigorous studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WITHDRAWN: Low level laser therapy for nonspecific low-back pain. Yousefi-Nooraie, R., Schonstein, E., Heidari, K., et al.[2020]

Low-level laser therapy (LLLT) shows some evidence of providing short-term and intermediate-term pain relief for patients with subacute and chronic low-back pain compared to sham therapy, based on a review of six randomized controlled trials.

No side effects were reported with LLLT, but the evidence is insufficient to make strong conclusions about its effectiveness for pain-related disability or lumbar range of motion, indicating a need for more rigorous studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low level laser therapy for nonspecific low-back pain. Yousefi-Nooraie, R., Schonstein, E., Heidari, K., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Low-level Laser Therapy on Postoperative Pain after Root Canal Retreatment: A Preliminary Placebo-controlled, Triple-blind, Randomized Clinical Trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Low-level laser therapy in dentistry. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Low level laser therapy for nonspecific low-back pain. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

Low level laser therapy for patients with cervical disk hernia. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial on low level laser therapy (LLLT) in the treatment of osteoarthritis (OA) of the hand. [2022]

8. England pubmed.ncbi.nlm.nih.gov

WITHDRAWN: Low level laser therapy for nonspecific low-back pain. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Low level laser therapy for nonspecific low-back pain. [2018]