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

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