Effects of Photobiomodulation on Inflammation and Chronic Pain in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Knee Pain Intensity (Numeric Rating Scale)
研究概览
简要总结
This study aims to determine analgesic and anti-inflammatory effects of dual-wavelength PBM in people with symptomatic knee OA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Active PBM
Participants will receive active photobiomodulation (PBM) delivered to peri-articular knee sites, lumbar segments L2-L5, genicular/saphenous nerve fields, and lymphatic drainage zones using the THOR® LX2.3 device and study-specified treatment parameters. Treatment will be administered in six sessions over 2-3 weeks at a frequency of 2-3 sessions per week.
干预措施: Photobiomodulation therapy (PBM) device (Device)
Sham PBM
Participants will receive sham photobiomodulation (PBM) delivered using a visually identical THOR® LX2.3 device that does not emit therapeutic light. Sham treatment will be administered to the same anatomical sites and according to the same treatment schedule as the active PBM group, consisting of six sessions over 2-3 weeks at a frequency of 2-3 sessions per week.
干预措施: Sham PBM device (Device)
结局指标
主要结局
Change in Knee Pain Intensity (Numeric Rating Scale)
时间窗: Baseline (Visit 0) to Final Follow-up (Visit 7; approximately 3-4 weeks after baseline)
Knee pain will be assessed using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Assessments will be conducted at baseline (V0) and at the final follow-up visit, one week after the last treatment session.
次要结局
未报告次要终点