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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of Trident low-level laser therapy (LLLT) in reducing lower back pain when combined with patient education. Participants will receive 2 to 8 laser treatments over a few weeks, with each session lasting 20 minutes. It suits individuals with consistent, significant lower back pain who have not recently used pain medications or treatments. As an unphased trial, this study provides a unique opportunity to contribute to innovative research and potentially find relief from persistent 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 prior data suggests that the Erchonia® Trident low-level laser therapy is safe for treating lower back pain?

Research shows that low-level laser therapy (LLLT) using the Erchonia Trident device is safe for treating lower back pain. Studies have found that patients generally tolerate this laser therapy well. The FDA has approved the Erchonia FX 635, a similar laser device, for treating pain throughout the body, confirming its safety standards. It is also approved for treating plantar fasciitis, further supporting its safety.

Previous studies have linked low-level laser therapy to very few side effects, meaning patients reported minimal problems. Therefore, strong evidence supports the safety of the Erchonia Trident for treating pain if considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for lower back pain, which often include medications, physical therapy, or invasive procedures like surgery, Erchonia® Trident uses low-level laser therapy (LLLT) to target pain. This approach is non-invasive and aims to reduce inflammation and promote tissue repair through laser light without the need for drugs or surgery. Researchers are excited about its potential for delivering pain relief with minimal side effects, and its customizable treatment regimens, like the 2, 4, 6, or 8-session options, offer flexibility based on patient needs. This innovative use of laser technology could provide a new, effective alternative for those seeking relief from chronic lower back pain.

What evidence suggests that this trial's treatments could be effective for lower back pain?

Studies have shown that low-level laser therapy (LLLT) can help treat lower back pain. In a clinical trial, Erchonia's FX 635 laser reduced pain in 72% of participants, leading to FDA approval. Another study found a 49% reduction in pain without any other treatments. This trial will evaluate the effectiveness of the Erchonia® Trident laser, with participants receiving varying numbers of LLLT treatments. These results suggest that LLLT, such as the Trident laser, might benefit people with chronic lower back pain. Although these findings are encouraging, results can vary from person to person. ^{1 2 3 4 6}

Who Is on the Research Team?

Ryan T Hurt, MD, PhD

Principal Investigator

Mayo Clinic

Ivana Croghan, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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) 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) 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) 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) 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06007976?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Erchonia%20Corporation%22))&rank=1

NCT06007976 | LLLT to Reduce Low Back Pain 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 ...

2. erchonia.com erchonia.com/wp-content/uploads/2022/10/Berry_Two-Randomized-Double-Blind-Placebo-Controlled-Trials-Evaluating-the-Efficacy-of-Red-635nm-3LT-for-the-Treatment-of-Low-.pdf

Two Randomized, Double Blind, Placebo- Controlled Trials ... A new emerging technology, low-level laser therapy (LLLT) has demonstrated promising results for the treatment of various chronic ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK596638/

Low-Level Laser Treatment for Lower Back Pain - NCBI - NIH Low-level laser therapy with Erchonia FX 635 is safe and may be effective for people experiencing low back pain. With this comes the possibility of an ...

4. aaos.org aaos.org/aaosnow/2019/oct/clinical/clinical04/

Literature Offers Little Direction on the Safety and Efficacy ... Erchonia reported an overall 49 percent reduction in pain without adjunctive treatment, which the company noted is favorable to the 20 percent ...

5. erchonia.com erchonia.com/laser-applications-2/

Cold Laser Therapy For Pain Treatment | Erchonia Erchonia's FX 635 laser showed a 72% success rate in their clinical trial, which received FDA market clearance in May 2018. The FX 635 treatment of chronic low ...

6. erchonia.com erchonia.com/wp-content/uploads/2020/03/Berry_FX-635-Laser-for-Treating-Low-Back-Pain-12-Months-Post-Follow-Up_Journal-of-Pain-Relief_2019-1.pdf

Low-Level Laser Therapy for Treating Low Back Pain Laser therapy can significantly reduce pain and disability and improve range of motion in patients with chronic LBP [17,18]. A low- level 635 ...