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

NCT07079969 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Knee Pain Chronic

Interventions

DEVICE

Photobiomodulation therapy (PBM) device

FDA-cleared near-infrared PBM device delivering therapeutic light to the affected knee. Administered once per session, approximately 10 minutes after topical application, in six sessions over 2-3 weeks (2-3 times per week).

DEVICE

Sham PBM device

Identical in appearance to the active PBM device but emits no therapeutic light. Administered once per session, approximately 10 minutes after topical application, in six sessions over 2-3 weeks.

DRUG

Diclofenac Sodium 1 % Topical Cream

Topical nonsteroidal anti-inflammatory drug applied at a dose of 4 grams to the affected knee, once per session, immediately before PBM/sham PBM. Used in six sessions over 2-3 weeks.

DRUG

Placebo topical cream

Inert cream matching the appearance of diclofenac sodium 1% gel. Applied at 4 grams to the affected knee, once per session, immediately before PBM/sham PBM. Used in six sessions over 2-3 weeks

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07079969 on ClinicalTrials.gov