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

Официальное название

Effects of Photobiomodulation on Inflammation and Chronic Pain in Knee Osteoarthritis

Обзор

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

Вмешательства

• Устройство 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).
• Устройство 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Florida — Gainesville

Идентификаторы

NCT: NCT07079969 · IRB202501000

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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