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

Official title

Effects of Photobiomodulation on Inflammation and Chronic Pain in Knee Osteoarthritis

Overview

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

Interventions

• 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.

Primary outcome measures

• Change in Knee Pain Intensity (Numeric Rating Scale) [Time frame: Baseline (Visit 0) to Final Follow-up (Visit 7; approximately 3-4 weeks after baseline)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Florida — Gainesville

Identifiers

NCT: NCT07079969 · IRB202501000

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗