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EPIC-KO

Photobiomodulation and Diclofenac for Knee Osteoarthritis

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What is being tested

Photobiomodulation therapy (PBM) device

+ Sham PBM device
+ Diclofenac Sodium 1 % Topical Cream
Device
Drug
Who is being recruted

Knee Pain Chronic

From 50 to 99 Years
+36 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 2
Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorUniversity of Florida
Study ContactSelenia Rubio, MD. MBA,
Last updated: October 2, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2025Actual 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 
Principal SponsorUniversity of Florida
Study ContactSelenia Rubio, MD. MBA,
Last updated: October 2, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different combinations of treatments to see how they work together. This approach helps researchers determine whether a combination of treatments is more effective than a single treatment alone.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 50 to 99 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Knee Pain Chronic
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

Show More Criteria

31 exclusion criteria prevent from participating
Known moderate to severe hepatic impairment
Pregnancy or lactation
Cognitive impairment that precludes informed consent or task participation
Active systemic rheumatic condition (e.g., rheumatoid arthritis, systemic lupus erythematosus)

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 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
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 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 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
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

Knee pain will be assessed using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Assessments will be conducted at baseline (V0) and at the final follow-up visit, one week after the last treatment session.

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 FloridaGainesville, United StatesSee the location
Recruiting soonOne Study Center