NCT07079969

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 50 Years – 99 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-07-23
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study