Light Therapy for Osteoarthritis

Overseen By Karim Mudkida, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Other clinical trial, Arthroscopic surgery

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

46 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that any medications you are taking have been stable for at least 14 days before starting the trial.

What data supports the effectiveness of the treatment Green LED light for osteoarthritis?

Research shows that light therapy, including low-power light therapy, can help reduce pain and disability in elderly patients with knee osteoarthritis. Although the effectiveness of similar treatments like Low Level Laser Therapy is still debated, some studies suggest potential benefits for cartilage repair and pain relief. ^{1 2 3 4 5}

Is light therapy safe for treating osteoarthritis?

Light therapy, including LED and low-level laser therapy, is generally considered safe with no known side effects reported in studies for osteoarthritis and other conditions. ^{3 6 7 8 9}

How is Green LED Light Therapy different from other treatments for osteoarthritis?

Green LED Light Therapy is unique because it uses specific wavelengths of light to potentially reduce inflammation and pain in osteoarthritis, unlike traditional treatments that often involve medication or physical therapy. This non-invasive approach may help with cartilage repair and improve joint function without the side effects associated with drugs. ^{3 4 10 11 12}

What is the purpose of this trial?

Managing joint pain is one of the main goals for treating osteoarthritis (OA) and other musculoskeletal disorders. Alleviating chronic pain pharmacologically has several potential drawbacks including diminishing efficacy, toxicity, adverse side-effects, and patient anxiety. Non-pharmacological approaches (eg. weight loss) have also been found to be effective at controlling joint pain and can provide supplementary benefits. The development of efficacious, alternative treatments for arthritis pain which provide analgesia without adverse side-effects would be advantageous. Recently, preclinical and clinical studies have demonstrated that green ambient light using light-emitting diodes (LEDs) produced profound analgesia in animal models and chronic pain patients. Both migraineurs and fibromyalgia patients have both reported significant reductions in pain following 10 weeks of green LED exposure. The investigators aim to assess the analgesic potential of green light therapy for people living with knee osteoarthritis. Participants will be asked to keep a pain diary for 4 weeks prior to light intervention. All participants will first use a white LED (20 lux) for 1-2 hours per day in a dark room at home for 10 weeks. Following a 2-week washout period without light use, participants will use a green LED (20 lux) for 1-2 hours per day in a dark room at home for 10 weeks. Following completion of the intervention, the investigator will assess changes in reported pain and quality of life. The investigators hypothesize that participants will have improvements in pain intensity and quality of life following treatment with green LEDs.

Research Team

Karim Mukhida, MD, PhD

Principal Investigator

Nova Scotia Health Authority

Eligibility Criteria

This trial is for adults with knee osteoarthritis who can read and write English, have moderate to severe pain, and stable medication use. They should be able to follow the study protocol and give informed consent. People with unstable housing or inability to attend visits are excluded.

Inclusion Criteria

My average pain level is more than 4 out of 10 over the last week.

I have knee pain, am over 50, and my knee is stiff, makes noise, feels tender or enlarged without being warm.

My current medications have been the same for the last 14 days.

Exclusion Criteria

Currently enrolled in other clinical trial involving a pharmaceutical treatment

I am scheduled for a joint surgery within the next 8 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Pain Assessment

Participants gather baseline pain information for 4 weeks without any light intervention

4 weeks

1 visit (in-person)

White LED Treatment

Participants use white LEDs for 1-2 hours per day in a dark room at home

10 weeks

1 visit (in-person)

Washout Period

Participants undergo a washout period without LED use

2 weeks

Green LED Treatment

Participants use green LEDs for 1-2 hours per day in a dark room at home

10 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain and quality of life after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Green LED light
• White LED light

Trial Overview The trial is testing if green LED light therapy reduces pain in knee osteoarthritis patients compared to white LED light. Participants will first use white LED at home for 10 weeks, then after a break, switch to green LED for another 10 weeks while keeping a pain diary.

Participant Groups

Group I: Green LED Experimental Treatment 2 Interventions

Participants will be asked to use green LEDs for 1-2 hours/day in a dark room in their home.

Group II: White LED Placebo Group 2 Interventions

Participants will be asked to use white LEDs for 1-2 hours/day in a dark room in their home.

Green LED light is already approved in United States for the following indications:

Approved in United States as Green Light Therapy for:

• Chronic pain in fibromyalgia and migraine
• Potential application in hypermobile Ehlers-Danlos Syndrome (hEDS)

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Findings from Research

A meta-analysis of seven trials involving 345 patients found that Low Level Laser Therapy (LLLT) showed conflicting results for pain relief in osteoarthritis, with no significant overall effect on pain scores, but some studies reported beneficial outcomes.

Lower doses of LLLT were found to be as effective as higher doses for reducing pain and improving knee range of motion, suggesting that treatment parameters may significantly influence the therapy's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low level laser therapy (Classes I, II and III) for treating osteoarthritis. Brosseau, L., Welch, V., Wells, G., et al.[2020]

This scoping review analyzed 47 studies on LED therapy for synovial joint disorders, including 15 clinical trials, and found some positive effects on cell proliferation and pain reduction, but results varied widely due to differences in device parameters and dosimetry.

The review highlighted the need for future research to address fundamental questions about LED therapy's effectiveness, such as optimal penetration depth and treatment duration, to better understand its impact on synovial joint conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of LED therapy to treat synovial joints disorders: scoping review. Coracini, CA., Dos Santos Soares, F., Bertolini, GRF.[2022]

Low-level LED therapy (880 nm) significantly reduced inflammation in a rat model of Achilles tendinitis, as evidenced by decreased inflammatory cell influx and lower levels of pro-inflammatory cytokines like IL-1 beta, IL-6, and TNF-alpha.

The therapy was effective when applied starting 12 hours after tendinitis induction, suggesting that LED treatment can enhance tissue response and reduce inflammation in tendon injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-inflammatory effects of low-level light emitting diode therapy on Achilles tendinitis in rats. Xavier, M., David, DR., de Souza, RA., et al.[2010]

References

1. England pubmed.ncbi.nlm.nih.gov

Low level laser therapy (classes I, II and III) for the treatment of osteoarthritis. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Low level laser therapy (Classes I, II and III) for treating osteoarthritis. [2020]

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

In Vitro and In Vivo Effects of Light Therapy on Cartilage Regeneration for Knee Osteoarthritis: A Systematic Review. [2022]

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

Improvement of pain and disability in elderly patients with degenerative osteoarthritis of the knee treated with narrow-band light therapy. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Low level laser therapy (Classes I, II and III) for treating osteoarthritis. [2019]

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

The use of LED therapy to treat synovial joints disorders: scoping review. [2022]

7. Iran pubmed.ncbi.nlm.nih.gov

Low level laser therapy for painful joints. [2020]

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

Can osteoarthritis be treated with light? [2021]

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

Effectiveness of phototherapy incorporated into an exercise program for osteoarthritis of the knee: study protocol for a randomized controlled trial. [2021]

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

Anti-inflammatory effect of low-level laser and light-emitting diode in zymosan-induced arthritis. [2015]

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

Anti-inflammatory effects of low-level light emitting diode therapy on Achilles tendinitis in rats. [2010]

12. England pubmed.ncbi.nlm.nih.gov

The effects of low-level laser therapy on muscle strength and functional outcomes in individuals with knee osteoarthritis: a double-blinded randomized controlled trial. [2023]