Inflammatory Targeted Low-level Laser Treatment of Knee Osteoarthritis - A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pain in general
研究概览
简要总结
This study is conducted to evaluate the effectiveness of low-level laser therapy (LLLT) as an adjunct to exercise therapy in knee osteoarthritis (KOA).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Two laser devices of the same appearance are used, i.e. one with 3x60 mW output power and one with 0 mW output power (sham). Participants in one group is treated with the sham laser device and the other group is treated with laser. The laser beam is invisible for the eye (wavelength 904 nm) and of such low power that heat is not detected. Thus, the participants, therapists and assessors are unaware of which laser device is active/inactive. The laser devices were randomly coded by a secretary who is not otherwise involved in the study.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Pain in general
时间窗: 0, 3, 8, 26 and 52 weeks after randomization
Pain in general is reported with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire pain subscale. The subscale is based on Likert scales, each with five severity categories. The raw KOOS score is transformed to a 0-100 percentage score (higher is better).
Pain on movement
时间窗: 0, 3, 8, 26 and 52 weeks after randomization
The participants are asked to rate their pain experienced on movement using an unidimensional visual analogue scale (VAS). "No pain" (0) is written in one end and "worst imaginable pain" (100) is written in the other end of the VAS tool.
Pain at night
时间窗: 0, 3, 8, 26 and 52 weeks after randomization
The participants are asked to rate their pain experienced in bed at night using an unidimensional visual analogue scale (VAS). "No pain" (0) is written in one end and "worst imaginable pain" (100) is written in the other end of the VAS tool.
Pain at rest
时间窗: 0, 3, 8, 26 and 52 weeks after randomization
The participants are asked to rate their pain experienced at rest in sitting position using an unidimensional visual analogue scale (VAS). "No pain" (0) is written in one end and "worst imaginable pain" (100) is written in the other end of the VAS tool.
次要结局
- Physical function in sports and recreational activities(0, 3, 8, 26 and 52 weeks after randomization)
- Real time ultrasonography assessment of neovascularization(0, 3, 8, 26 and 52 weeks after randomization)
- 30 seconds chair stand(0, 3, 8, 26 and 52 weeks after randomization)
- Tibia bone pain pressure threshold(0, 3, 8, 26 and 52 weeks after randomization)
- Real time ultrasonography assessment of femur cartilage thickness(0, 3, 8, 26 and 52 weeks after randomization)
- Knee extension active range of motion(0, 3, 8, 26 and 52 weeks after randomization)
- Maximum pain free isometric quadriceps strength(0, 3, 8, 26 and 52 weeks after randomization)
- Joint line pain pressure threshold(0, 3, 8, 26 and 52 weeks after randomization)
- Physical function in daily living(0, 3, 8, 26 and 52 weeks after randomization)
- Quality of life(0, 3, 8, 26 and 52 weeks after randomization)
- Global health status assessment(8 weeks after randomization)
- Real time ultrasonography assessment of effusion(0, 3, 8, 26 and 52 weeks after randomization)
- Knee flexion active range of motion(0, 3, 8, 26 and 52 weeks after randomization)
- Analgesic drug consumption due to knee pain(0, 3, 8, 26 and 52 weeks after randomization)