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Effects of Photobiomodulation and Topical Diclofenac on Inflammation and Pain in Knee Osteoarthritis (EPIC-KO) | Clinical Trials | Clareo Health

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Effects of Photobiomodulation and Topical Diclofenac on Inflammation and Pain in Knee Osteoarthritis (EPIC-KO)

Effects of Photobiomodulation and Topical Diclofenac on Inflammation and Pain in Knee Osteoarthritis

NCT07079969•University of Florida

View on ClinicalTrials.gov

Summary

This study aims to compare the effects of combined treatments-dual-wavelength photobiomodulation (PBM) with or without topical diclofenac-on inflammation, pain, and joint function in patients with knee osteoarthritis (OA). It also seeks to determine the synergistic effect of PBM plus topical diclofenac on inflammatory markers, pain scores, and functional outcomes.

Eligibility

Age

50 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
•Capacity to perform all study tasks (Timed Up-and-Go, knee OA assessments, blood draw, questionnaires, etc)

Exclusion Criteria

•Systemic and Rheumatic Disease
•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
•Musculoskeletal History
•Clinically significant surgery on the index knee (e.g., arthroplasty, osteotomy)
•Knee surgery within the past 6 weeks
•Intra-articular injection to the index knee within the past 14 days
•Medication Use
•Daily opioid therapy
•Hypersensitivity or allergy to diclofenac, other NSAIDs, or PBM
+32 more criteria

Locations (1)

University of Florida

Gainesville, Florida, United States

Key Dates

Start Date

April 1, 2026

Primary Completion Date

July 1, 2026

Completion Date

July 1, 2026

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Knee Pain Chronic

Interventions

Photobiomodulation therapy (PBM) device

DEVICE

Sham PBM device

DEVICE

Diclofenac Sodium 1 % Topical Cream

DRUG

Placebo topical cream

DRUG

Contacts

Selenia Rubio, MD. MBA,

CONTACT

352-273-5590 srubio7@ufl.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of Photobiomodulation and Topical Diclofenac on Inflammation and Pain in Knee Osteoarthritis (EPIC-KO)

Inclusion Criteria

Exclusion Criteria

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