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

Trial Summary

What is the purpose of this trial?

Determine the most effective and efficient treatment protocols for treating neck pain with LLLT.

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.

How does the Phoenix Thera-Lase Device treatment for neck pain differ from other treatments?

The Phoenix Thera-Lase Device uses low-level laser therapy (LLLT), a non-invasive treatment that applies non-thermal laser light to painful areas, triggering biochemical changes in cells to reduce pain and inflammation. This approach is unique because it does not rely on drugs, which often have side effects, and it has shown significant pain relief in clinical trials for chronic neck pain. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment 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 reduced inflammation. Studies have demonstrated its effectiveness in managing pain for various conditions, including chronic pain and osteoarthritis. ^{2 3 4 6 7}

Research Team

Paul F Crawford, MD

Principal Investigator

US Air Force

Eligibility Criteria

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 nerve pain or weakness from my neck.

I have an open wound on my neck.

I have rheumatoid arthritis.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. 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]

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

660 AsGaAl laser to alleviate pain caused by cryosurgical treatment of oral leukoplakia: a preliminary study. [2015]

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

Analgesic effect of He-Ne (632.8 nm) low-level laser therapy on acute inflammatory pain. [2015]

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

[Phototherapy for chronic pain treatment]. [2015]

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

The effect of 300 mW, 830 nm laser on chronic neck pain: a double-blind, randomized, placebo-controlled study. [2022]

7. Japan pubmed.ncbi.nlm.nih.gov

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