Randomized, Sham Controlled, Single Blind Study on the Performance and Safety of Photo Biomodulation Therapy (PBMT) With LightForce® Therapy Lasers on Knee Osteoarthritis Pain Reduction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
- 试验地点
- 9
- 主要终点
- Pain change
研究概览
简要总结
DJO UK Ltd (ENOVIS) is conducting this study to assess the effectiveness of LightForce® Therapy Lasers on pain reduction in subjects with unilateral or bilateral knee osteoarthritis. In detail this study will assess superiority of LightForce® Therapy Lasers combined with standard of care, represented by physiotherapy/exercise program compared to sham laser combined with standard of care (physiotherapy/exercise program) on pain reduction in subjects with knee osteoarthritis. In addition, this study allows to collect post market clinical data on the safety and performance of LightForce® Therapy Lasers, when used, following the normal clinical practice, in accordance with its approved and CE marked intended use.
详细描述
This clinical investigation is a post-market, International, multi center, prospective, randomized, sham controlled, single blind study to assess the effectiveness of LightForce® Therapy Lasers and to collect PMCF data on the safety and performance of LightForce® Therapy Lasers, when used in accordance with its approved labeling, to comply with Medical Device Regulation (EU) 2017/745 (MDR) Article 61 and Part B of Annex XI.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient male or female with age ≥18 years old
- •Patient with radiographic diagnosis of knee osteoarthritis (as confirmed by x- ray or CT scan) to be treated by LightForce® Therapy Lasers according its indications.
- •Patient with Kellgren and Lawrence grade 2-3 unilateral or bilateral knee osteoarthritis
- •Patient suffering from knee osteoarthritis pain for more than 6 months prior to enrollment
- •Pain (either persistent or during activities) score reported by the subject at baseline ≥ 40 mm measured on VAS
- •Patient able to provide written informed consent
- •Patient with BMI ≤30 kg/m2
- •For FRANCE ONLY: To be affiliated to the social security system or to be beneficiary of such system
排除标准
- •Patient with musculoskeletal pathological conditions not to be treated with/contraindication to the use of LightForce® Therapy Lasers according to its intended use and indications
- •Patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to certain types of steroids
- •Patients who are administered with corticosteroids, should discontinue the treatment at least 2 weeks prior to study treatment start
- •Pregnant females or females of childbearing potentially planning to become pregnant during the study participation
- •Patients who had inflammatory arthritis (i.e. rheumatoid arthritis, psoriatic arthritis)
- •Patients who underwent intra-articular injection (Ialuronic acid, platelet rich plasma or corticosteroids) in the knee in the last 6 months
- •Patients who have a disease that would limit their participation in exercises (i.e. severe chronic obstructive pulmonary disease, severe heart failure, cerebrovascular event history)
- •Patients who have hip or ankle/foot joint pathology that might interfere with participation in exercises/knee recovery
- •Patients with a diagnosis of active cancer
- •Patients with tattoos covering more than 30% of the area to be treated with LightForce® Therapy Lasers
- •Patients who are mentally or physically incapacitated
- •Patient participating in other clinical study or has completed a clinical study less than 30 days prior to enrollment
- •Patients with other musculoskeletal problems of the knee joint such as tendon or ligament injury, recent surgery, recent fracture, or recent meniscus injury and/or undergoing to specific physiotherapy for these ("recent" is defined as within 30 days prior to enrollment)
- •Patients with other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator.
结局指标
主要结局
Pain change
时间窗: 6 weeks after treatment start
Pain reduction measured with Visual Analog Scale (VAS) (0-100 mm) after 6 weeks of treatment compared to pre-treatment (baseline) VAS
次要结局
- Safety - adverse event rate(through study completion, an average of 12 weeks)