Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: An Open Label, Single-Arm Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- level of pain
研究概览
简要总结
Osteoarthritis is a degenerative disease affecting joint cartilage and its surrounding tissue. It is the leading cause of disability in the elderly. Photobiomodulation (PBM), has been used widely for alleviation of pain, reduction of inflammation, and acceleration of wound healing, and particularly to treat knee osteoarthritis (KOA). The purpose of the current study is to determine if B-Cure laser treatments, applied at home, by the patient or personal caregiver in a real-life situation, can reduce pain and improve functionality in patients with KOA.
详细描述
Eligible patients with knee osteoarthritis will receive a B-Cure laser device for self-application at home in addition to standard care. Patients will be invited to the clinic for 3 visits: baseline, 1, and 2 months. Evaluations at the visits will include physical examination, knee range of motion, time up&go test, and patient reported outcomes including subjective pain level by visual analogue scale (VAS), functional and quality of life questionnaires.
The study hypothesis is that B-Cure laser treatments, applied, at home, by the patient, can ameliorate KOA related inflammation thereby reducing pain and improving functionality in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR)
- •Kellgren & Lawrence classification 2-3
- •Knee pain on movement 40 to 90 mm Visual Analog Scale
- •Knee pain and related functional reduction for the last ≥ 3 months
- •Agrees not to use NSAIDs throughout the experiment
排除标准
- •Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control
- •Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, radiculopathy etc) have been ruled out by physical examinations.
- •Knee surgery for KOA
- •Intra-articular steroid injection and/or oral steroid treatment within the last six months
- •Rheumatoid arthritis
- •Active malignancy
- •Uncontrolled diabetes mellitus
- •Neurological conditions: sciatica, neuropathy, multiple sclerosis
- •Other chronic pain conditions that may affect results: Fibromyalgia, back pain, hip pain
- •Has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for knee pain
- •Has known dermatological sensitivity to light
- •Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.
结局指标
主要结局
level of pain
时间窗: one month
Change from baseline in pain score by VAS
次要结局
- Change from baseline in WOMAC score [ time point - 1 month](one month)