Effects of Photobiomodulation on Inflammation and Chronic Pain in Knee Osteoarthritis (EPIC-KO)
Not yet recruitingNot applicableNCT07079969
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study aims to determine analgesic and anti-inflammatory effects of dual-wavelength PBM in people with symptomatic knee OA.
Study details
- Official title
- Effects of Photobiomodulation on Inflammation and Chronic Pain in Knee Osteoarthritis
- Conditions
- Interventions
- Device: Photobiomodulation therapy (PBM) device
- Device: Sham PBM device
- Sponsor
- University of Florida
- Start date
- 2026-09
- Primary completion
- 2027-09
- Sex
- All
- Age range
- from 50 Years to 99 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07079969