Photobiomodulation + Diclofenac for Chronic Knee Pain

(EPIC-KO Trial)

Overseen By Selenia Rubio, MD. MBA,

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Florida

Must not be taking: Opioids, Sodium-channel blockers

Disqualifiers: Rheumatoid arthritis, Fibromyalgia, Uncontrolled hypertension, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 2-3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial tests new treatments for knee osteoarthritis, a type of arthritis causing joint pain and swelling, using photobiomodulation therapy (a light treatment) and a topical diclofenac cream. The goal is to assess how these treatments, used alone or together, impact inflammation, pain, and knee function. Individuals with knee pain from osteoarthritis for at least three months who can attend study visits may be suitable for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot participate if you are on daily opioid therapy, certain pain medications, or if you started a new pain treatment within 30 days before screening. Check with the trial team about your specific medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that photobiomodulation (PBM) therapy is very safe. Most people tolerate it well, and research highlights its safety. The main precaution is to avoid shining the light in the eyes. Overall, PBM appears safe.

Diclofenac sodium 1% topical cream is another treatment under testing. It is already used to relieve pain and swelling from arthritis. Rare risks of serious side effects, such as heart or stomach problems, usually occur with long-term or incorrect use. When used as directed, it is generally safe and well-tolerated.

At least one other human trial has tested the combination of PBM and diclofenac. This combination aims to enhance the effects of both treatments. Although specific safety data for the combination is limited, the fact that each treatment is well-tolerated on its own is encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for chronic knee pain because they explore combining photobiomodulation (PBM) with diclofenac cream, aiming for enhanced pain relief. Unlike standard treatments that typically involve oral NSAIDs or steroid injections, PBM uses light to stimulate healing and reduce inflammation directly. This non-invasive approach, especially when paired with diclofenac's topical anti-inflammatory action, could offer effective pain relief with fewer side effects. Additionally, combining these therapies might accelerate recovery, providing benefits in just a few weeks, which is promising for individuals seeking quicker relief from chronic discomfort.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Studies have shown that light therapy, known as photobiomodulation (PBM), can significantly reduce pain and improve movement in people with knee osteoarthritis (OA). In some cases, pain decreased by more than 50% after treatment. Research also indicates that applying diclofenac cream to the skin effectively reduces arthritis pain and improves joint function. In this trial, participants will be assigned to different treatment arms to evaluate these therapies: one group will receive PBM only, another will receive diclofenac only, and a third group will receive a combination of both PBM and diclofenac. These findings suggest that combining PBM and diclofenac could be a promising approach for managing knee OA symptoms. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

The EPIC-KO trial is for individuals with chronic knee pain due to osteoarthritis. Specific eligibility criteria are not provided, but typically participants should have a confirmed diagnosis of OA and be experiencing symptoms like pain and reduced joint function.

Inclusion Criteria

Ability to give informed consent, attend visits, and complete ≥ 4 of 7 DSD entries pre-randomization

I have knee pain from arthritis for 3 months or more.

My average knee pain is 30 or more out of 100.

Exclusion Criteria

I have fibromyalgia with pain in areas other than my knee as bad or worse than in my knee.

I have had major surgery on my knee.

I had knee surgery within the last 6 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either PBM, diclofenac, combined treatment, or placebo over six sessions

2-3 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Diclofenac Sodium 1 % Topical Cream
• Photobiomodulation therapy (PBM)

Trial Overview This study tests the effectiveness of photobiomodulation (PBM) therapy alone or combined with diclofenac cream on inflammation, pain relief, and improved joint function in knee OA patients. It compares these treatments against sham devices and placebo creams.

How Is the Trial Designed?

Group I: PBM Only Experimental Treatment 2 Interventions

Participants will receive placebo topical cream (identical in appearance to diclofenac sodium 1% gel), applied at a dose of 4 grams to the affected knee during each treatment session. They will also receive active photobiomodulation therapy (PBM) using an FDA-cleared near-infrared device. PBM will be administered approximately 10 minutes after placebo cream application. Both treatments will be delivered in six sessions over a 2-3 week period, at a frequency of 2-3 times per week.

Group II: Diclofenac only Experimental Treatment 2 Interventions

Participants will receive diclofenac sodium 1% topical cream, applied at a dose of 4 grams to the affected knee during each treatment session. They will also receive sham PBM using a device identical in appearance to the active PBM device but without therapeutic light output. Sham PBM will be administered approximately 10 minutes after diclofenac cream application. Both treatments will be delivered in six sessions over 2-3 weeks, at a frequency of 2-3 times per week.

Group III: Combined Experimental Treatment 2 Interventions

Participants will receive diclofenac sodium 1% topical cream, applied at a dose of 4 grams to the affected knee during each treatment session. They will also receive active PBM using the same device and parameters described above. PBM will be administered approximately 10 minutes after diclofenac cream application. Both treatments will be delivered in six sessions over 2-3 weeks, at a frequency of 2-3 times per week.

Group IV: Double placebo Placebo Group 2 Interventions

Participants will receive placebo topical cream, applied at a dose of 4 grams to the affected knee during each treatment session. They will also receive sham PBM using a visually identical device that does not emit therapeutic light. Sham PBM will be administered approximately 10 minutes after placebo cream application. Both treatments will be delivered in six sessions over 2-3 weeks, at a frequency of 2-3 times per week.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Citations

1. withpower.com withpower.com/trial/phase-2-knee-pain-chronic-7-2025-f3dec

Photobiomodulation + Diclofenac for Chronic Knee Pain This study aims to compare the effects of combined treatments-dual-wavelength photobiomodulation (PBM) with or without topical diclofenac-on inflammation, ...

2. patlynk.com patlynk.com/trial/NCT07079969

Photobiomodulation and Diclofenac for Knee Osteoarthritis This study is focused on finding better ways to reduce inflammation and pain in people who have knee osteoarthritis, a common joint condition that can make ...

3. spiedigitallibrary.org spiedigitallibrary.org/journals/journal-of-biomedical-optics/volume-21/issue-10/108001/Isolated-and-combined-effects-of-photobiomodulation-therapy-topical-nonsteroidal-anti/10.1117/1.JBO.21.10.108001.full

Isolated and combined effects of photobiomodulation ... The results of this study indicate that PBMT is the most effective therapy in stopping disease progression, and improving inflammatory ...

4. pdfs.semanticscholar.org pdfs.semanticscholar.org/24ae/ca99fbb93966d8f4a6fd48955e6846d83132.pdf

Photobiomodulation therapy enhances topical diclofenac ... The aim of this study was to evaluate the effects of Photobiomodulation on topical absorption of sodium diclofenac in healthy volunteers.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10687633/

Current advances of photobiomodulation therapy in treating ... After the 10-day treatments, pain was remarkably reduced by more than fifty percent and physical functions of patients were significantly improved in both laser ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21174485/

Safety and efficacy of topical diclofenac sodium gel for ... Conclusions: DSG was effective and generally well tolerated in adults regardless of age. These data support the topical application of DSG for relief of OA knee ...

7. researchgate.net researchgate.net/publication/354698001_Photobiomodulation_therapy_enhances_topical_diclofenac_absorption_in_healthy_volunteers_-_a_randomized_placebo-controlled_trial_preliminary_results

Photobiomodulation therapy enhances topical diclofenac ... The aim of this study was to evaluate the effects of Photobiomodulation on topical absorption of sodium diclofenac in healthy volunteers.