Low-level Laser Therapy for Neck Pain

Overseen By Jill M Clark, MBA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Paul Crawford

Disqualifiers: Pregnant, Cervical radiculopathy, Rheumatoid arthritis, Fibromyalgia, others

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

Compensation: Varies

Number of Visits: 13

Duration: 10 days

296 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of low-level laser therapy (LLLT) in treating neck pain. Participants will use either the Phoenix Thera-Lase device or the Pinnacle Series Laser device, with varying settings, to determine which is most effective. It is ideal for active duty US Air Force pilots or onboard navigators who have experienced neck pain for over two months. Participants must be able to receive care at Nellis Air Force Base to join. As an unphased trial, this study allows participants to contribute to innovative research that could enhance treatment options for neck pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you should not have had physiotherapy or local injections in the 3 months before starting the study.

What prior data suggests that these laser devices are safe for treating neck pain?

Research has shown that the Pinnacle Series Laser System is safe and easy for patients to use. This device employs advanced laser technology to deliver more energy than other therapy lasers, making it effective and pain-free. It does not require anesthesia, reducing the chance of side effects during treatment.

The Phoenix Thera-Lase Device includes built-in safety features to protect both patients and users. These features prevent overload, helping to avoid potential problems. The device also reduces the need for additional pain medication, demonstrating effective pain management with minimal risk.

Both devices are part of ongoing research and have demonstrated promising safety results. While these findings are encouraging, consulting healthcare professionals is always advisable to understand the specific risks and benefits for individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about low-level laser therapy (LLLT) for neck pain because it offers a non-invasive alternative to typical treatments like medication or physical therapy. Unlike traditional approaches that often involve drugs or manual manipulation, LLLT uses light to potentially reduce pain and inflammation. The Pinnacle Series Laser device is being tested with varying dosimetry parameters, which means researchers are exploring different light intensities to find the most effective dosage. The Phoenix Thera-Lase device offers another unique approach, potentially providing a different light delivery method that might enhance pain relief. These innovative techniques could offer faster pain relief with fewer side effects compared to current treatments.

What evidence suggests that these trial's laser devices could be effective for neck pain?

Research shows that low-level laser therapy (LLLT) can effectively reduce neck pain. In this trial, participants will receive treatment with either the Pinnacle Series Laser or the Phoenix Thera-Lase Device. Studies have found that the Pinnacle Series Laser provides significant pain relief immediately after treatment and for up to 22 weeks in individuals with long-term neck pain. This device uses high energy, crucial for effective laser treatment. Similarly, the Phoenix Thera-Lase Device has demonstrated effectiveness in reducing pain in chronic conditions. It uses light to induce positive cellular changes, leading to pain relief. Both devices offer promising options for managing neck pain through LLLT. ^{1 2 3 6 7}

Who Is on the Research Team?

Paul F Crawford, MD

Principal Investigator

US Air Force

Are You a Good Fit for This Trial?

This trial is for active US Air Force pilots or navigators, aged 18-62, who can get care at Nellis Air Force Base. They should have had neck pain for over two months and a moderate disability score on the Neck Disability Index. Exclusions include those with open neck wounds, pacemakers, certain chronic diseases like fibromyalgia or rheumatoid arthritis, recent major surgery or trauma, pregnancy, and unstable cervical conditions.

Inclusion Criteria

Maintain operational flight status at enrollment or within the last 6 months

I am an active US Air Force pilot or navigator, aged 18-62.

I haven't had physiotherapy or local injections in the last 3 months.

Exclusion Criteria

I have an open wound on my neck.

I have nerve pain or weakness from my neck.

I have rheumatoid arthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive low-level laser therapy (LLLT) using different dosimetry parameters

10 days

10 visits (in-person)

Follow-up

Participants are monitored for changes in neck pain and biomarker levels after treatment

2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Phoenix Thera-Lase Device
• Pinnacle Series Laser Device

Trial Overview The study aims to find out which low-level laser therapy (LLLT) device is best for treating neck pain in air force personnel. Participants will be divided into three groups; each group will receive treatment using different LLLT devices: Phoenix Thera-Lase Device or Pinnacle Series Laser Device.

How Is the Trial Designed?

Group I: Group 3 (Phoenix) Experimental Treatment 1 Intervention

Utilizing the Phoenix Thera-Lase by Phoenix Thera-Lase Systems, we will apply LLT.

Group II: Group 2 (Pinnacle, higher dosimetry parameters) Experimental Treatment 1 Intervention

Utilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT

Group III: Group 1 (Pinnacle, lower dosimetry parameters) Experimental Treatment 1 Intervention

Utilize the Pinnacle Series Laser by Aspen Laser Systems to apply LLLT

Phoenix Thera-Lase Device is already approved in United States for the following indications:

Approved in United States as Phoenix Thera-Lase System for:

• Temporary relief of minor muscle and joint pain
• Muscle spasm
• Pain and stiffness associated with minor arthritis
• Promoting relaxation of muscle tissue
• Temporarily increasing local blood circulation

Who Is Running the Clinical Trial?

Paul Crawford

Lead Sponsor

Trials

6

Recruited

970+

Published Research Related to This Trial

Low level laser therapy (LLLT) using a He-Ne laser significantly increased pain thresholds in male Wistar rats by 68% to 95% and reduced inflammation by 54%, indicating its potential as an effective treatment for acute inflammatory pain.

The analgesic effect of LLLT appears to work through mechanisms involving hyperalgesic mediators rather than peripheral opioid receptors, suggesting a different pathway for pain relief compared to traditional analgesics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic effect of He-Ne (632.8 nm) low-level laser therapy on acute inflammatory pain. Ferreira, DM., Zângaro, RA., Villaverde, AB., et al.[2015]

In a study of 90 subjects with chronic neck pain, low-level laser therapy (LLLT) significantly reduced pain levels, with an average improvement of 2.7 points on a 10 cm Visual Analogue Scale (VAS) compared to a worsening of 0.3 points in the placebo group.

LLLT also led to significant improvements in quality of life and neck pain-specific questionnaires, demonstrating its efficacy in managing chronic neck pain over a treatment period of 7 weeks and follow-up at 12 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of 300 mW, 830 nm laser on chronic neck pain: a double-blind, randomized, placebo-controlled study. Chow, RT., Heller, GZ., Barnsley, L.[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]

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]

In a study involving 18 patients, those who received low-level laser therapy (LLLT) after cryosurgical treatment for oral leukoplakia reported significantly less pain compared to those who did not receive LLLT.

The LLLT group showed no evidence of recurrence of oral leukoplakia during an average follow-up of 9 months, suggesting that LLLT not only alleviates pain but may also support healing after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

660 AsGaAl laser to alleviate pain caused by cryosurgical treatment of oral leukoplakia: a preliminary study. Ribeiro, AS., de Aguiar, MC., do Carmo, MA., et al.[2015]

The MEDILASER SOFT PULSE10, a low reactive level laser therapy (LLLT) machine, is as safe as a 1 W machine but is effective at penetrating tissues twice as deep, enhancing its therapeutic potential for chronic pain.

Both 1 W and 10 W LLLT have shown significant analgesic effects in double-blind tests, suggesting that LLLT can effectively reduce pain by normalizing the overloaded sympathetic nervous system and increasing ATP concentrations in cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Phototherapy for chronic pain treatment]. Ide, Y.[2015]

Citations

1. phoenixthera-lase.com phoenixthera-lase.com/

Phoenix Thera-Lase Systems – The Future of Healing and ... A successful laser therapy treatment system that combines the best of current technologies with innovative, industry-leading features.

2. withpower.com withpower.com/trial/phase-neck-pain-9-2020-f2667

Low-level Laser Therapy for Neck Pain Research shows that low-level laser therapy (LLLT) can help reduce neck pain by using light to trigger beneficial changes in cells, leading to pain relief and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02964000

Phoenix Thera-Lase for Treating Chronic Pain in Patients ... Previous studies with low level laser therapy have reported beneficial effects on the level of pain in patients with a variety of chronic pain conditions. We ...

4. researchgate.net researchgate.net/publication/319229164_Effect_of_High-Intensity_Laser_Treatments_on_Chronic_Pain_Related_to_Osteoarthritis_in_Former_Professional_Athletes_A_Case_Series

Effect of High-Intensity Laser Treatments on Chronic Pain ... ... laser therapy (HILT) with the 42 watt Phoenix era-lase device could. achieve a sustained reduction in joint pain at rest and with activity.

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/K151521.pdf

Phoenix Thera-Lase Systems, LLC Ə Ms. Diane Rutherford ... The Laser system consists of three main components: Laser Diode Module,. Remote Controller, and Fiber Optic delivery cable with hand piece. The.

6. creamerphysicaltherapy.com creamerphysicaltherapy.com/services/phoenix-thera-lase-the-future-of-noninvasive-pain-management/

Phoenix Thera-Lase: The Future of Noninvasive Pain ... The Phoenix Thera-Lase System is a state-of-the-art Class IV laser therapy device. It utilizes high-powered laser technology to penetrate deeply into tissues.

7. bwprimarycare.com bwprimarycare.com/wp-content/uploads/2018/07/LASERRESEARCHrhuematology-article.pdf

Treatment of drug-resistant fibromyalgia symptoms using ... The initial treatment with the Phoenix. Thera-lase lasted 40 min and produced a beneficial effect on her joint pain (VAS = 1–2), as well as improved range of ...