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

Launched by UNIVERSITY OF FLORIDA · Jul 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people with knee osteoarthritis, a common condition that causes knee pain and stiffness. The trial is testing whether using a special light therapy called photobiomodulation (PBM), either alone or combined with a pain-relief gel called topical diclofenac, can reduce inflammation, ease pain, and improve how well the knee works. Researchers want to see if using both treatments together works better than using the light therapy by itself.

The study is looking for adults aged 50 and older who have knee osteoarthritis with ongoing knee pain lasting at least three months. To join, participants need to have moderate knee pain and be able to complete simple tasks like filling out symptom diaries, doing mobility tests, answering questions, and having blood samples taken. People with certain health issues—like recent knee surgery, serious heart problems, active infections or skin problems near the knee, or allergies to the treatments—would not be able to take part. Participants can expect to attend study visits where their pain levels, knee function, and inflammation will be measured to see how well the treatments work. This study is not yet enrolling participants but aims to find better ways to relieve knee pain and improve quality of life for those living with osteoarthritis.

Gender

ALL

Eligibility criteria

• 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
• • Use of centrally acting sodium-channel blockers or NMDA-receptor antagonists
• • New prescription or OTC analgesic, non-pharmacologic pain therapy, investigational drug, chemotherapy, or radiation therapy initiated ≤ 30 days before screening
• • Clinically significant drug interaction between topical diclofenac and concomitant medications per Drugs.com Drug Interaction Checker
• • Cardiovascular Safety
• • Uncontrolled hypertension (SBP \> 150 mmHg or DBP \> 95 mmHg)
• • Unstable or activity-limiting cardiovascular or peripheral arterial disease
• • Neurological and Psychiatric Conditions
• • Diagnosed neurological disorder (e.g., Parkinson's disease, multiple sclerosis, epilepsy)
• • History or evidence of stroke or moderate-severe traumatic brain injury
• • Serious psychiatric illness requiring hospitalization within the past 12 months
• • Active suicidal ideation
• • Current substance-use disorder or past hospitalization for substance-use treatment
• • Dermatologic Conditions
• • Compromised skin integrity at or near the treatment site (e.g., open wounds, active rash, dermatitis, burns, ulcers, eczema, infection) interfering with topical treatment or PBM
• • Renal Function
• • Severe renal impairment
• • History of acute kidney injury within the past 6 months
• • Hepatic Function
• • Active liver disease or elevated liver enzymes
• • Known moderate to severe hepatic impairment
• • Acute or chronic liver disease such as hepatitis
• • Other Metabolic Conditions
• • Uncontrolled diabetes
• • Diabetes-related complications (e.g., peripheral neuropathy, severe nephropathy, chronic ulcers at treatment site)
• • Active peptic ulcers or history of recurrent peptic ulcers with complications (e.g., bleeding, perforation)
• • Current use of anticoagulants with a history of gastrointestinal ulceration
• • Other Pain Conditions
• • Chronic pain at another body site more severe than knee pain
• • General Health and Cognition
• • Severe circulatory disorder
• • Pregnancy or lactation
• • Cognitive impairment that precludes informed consent or task participation