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Not Yet Recruiting NCT07079969

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

Conditions: Chronic Knee Pain

Sex: All
Ages: 50 Years – 99 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: University of Florida

Location: University of Florida Gainesville Florida

Summary

This study aims to determine analgesic and anti-inflammatory effects of dual-wavelength PBM in people with symptomatic knee OA.

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 to PBM * Migraine triggered by light * Open wounds, skin infections, eczema, burns, or other dermatologic conditions at or near the treatment application site. * New prescription or OTC analgesic, non-pharmacologic pain therapy, chemotherapy, or radiation therapy initiated ≤ 30 days before screening 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 Other Metabolic Conditions * Uncontrolled diabetes * Diabetes-related complications (e.g., peripheral neuropathy, severe nephropathy, chronic ulcers at treatment site) Other Pain Conditions * Chronic pain at another body site more severe than knee pain General Health and Cognition * Pregnancy or lactation * Cognitive impairment that precludes informed consent or task participation

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07079969). StuddyBuddy aggregates publicly available trial information.