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EPIC-KOPhotobiomodulation and Diclofenac for Knee Osteoarthritis

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What is being tested

Photobiomodulation therapy (PBM) device

+ Diclofenac Sodium 1 % Topical Cream

+ Placebo topical cream

DeviceDrug
Who is being recruted

From 50 to 99 Years
+36 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: January 2026
See protocol details

Summary

Principal SponsorUniversity of Florida
Study ContactSelenia Rubio, MD. MBA,
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2026

Actual date on which the first participant was enrolled.

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 movement difficult. Researchers are testing two treatments: a light therapy called photobiomodulation (PBM), which uses specific wavelengths of light to help with healing, and a gel containing diclofenac, a medicine often used to treat pain and inflammation. The main goal is to see if using both treatments together is more effective than using just the light therapy alone, which could lead to improved joint function and less pain for those suffering from this condition. Participants in the study will receive either the combined treatment of PBM and diclofenac gel or just the PBM therapy. The PBM therapy involves using a device that emits light directly onto the knee, while the diclofenac is applied as a gel on the skin. Scientists will monitor changes in pain levels, swelling, and how well the knee functions over time. By measuring these outcomes, the study aims to understand the benefits, if any, of combining these treatments, which could provide a new, more effective approach for managing knee osteoarthritis symptoms.

Official TitleEffects of Photobiomodulation and Topical Diclofenac on Inflammation and Pain in Knee Osteoarthritis 
NCT07079969
Principal SponsorUniversity of Florida
Study ContactSelenia Rubio, MD. MBA,
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 50 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Clinically confirmed knee osteoarthritis (OA) based on the American College of Rheumatology (ACR) criteria with symptomatic pain for ≥ 3 months

Average knee-pain intensity ≥ 30/100 on both the Daily Symptom Diary (DSD) run-in and CATI

Age ≥ 50 years

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

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31 exclusion criteria prevent from participating
Pregnancy or lactation

Cognitive impairment that precludes informed consent or task participation

Active systemic rheumatic condition (e.g., rheumatoid arthritis, systemic lupus erythematosus)

Fibromyalgia with pain outside the knee that is equal to or worse than knee pain

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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 II

Experimental
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 III

Experimental
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 IV

Placebo
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Florida

Gainesville, United StatesSee the location
Recruiting soonOne Study Center