Effectiveness of High-intensity Laser Therapy in Shoulder Osteoarthritis; a Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in the pain perception
研究概览
简要总结
This study will determine the efficacy of High Intensity Laser Therapy (HILT) for the treatment of shoulder osteoarthritis.
详细描述
Shoulder osteoarthritis (SO) is a musculoskeletal joint disease that affects the elderly. SO is characterized by degeneration of the articular cartilage in the involved joints and its underlying bone within a joint as well as bony overgrowth. It is one of the major causes of physical disability that has a social and public health impact due to pain, stiffness, joint instability, and muscle weakness.
The diagnosed patients with SO will be treated with HILT for a total of ten sessions during the entire duration of the treatment protocol. Parameters to be evaluated are: range of motion, pressure pain (algometer), pain perception (Visual Analog Scale (VAS), Modified Laitinen Pain Questionnaire), quality of life (WHOQoL-BREF) These parameters will be recorded before the first treatment (baseline), after completion of treatment, three and 12 months after completion treatment. A change in above parameters will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •painful osteoarthritis of the shoulder for at least 6 months
- •not engage in any other treatment during treatment period
- •pain ≥4 on the visual analog scale (VAS) in the previous 3 months
排除标准
- •presence of any other musculoskeletal problems associated with the shoulder joint, such as fracture, tendon or ligament tears, meniscus injury, rheumatoid arthritis, or shoulder surgery
- •receiving physical therapy and/or intra-articular corticosteroid or hyaluronic acid injections during the last 6 months
- •absolute and relative contraindications of Laser Therapy
结局指标
主要结局
Change in the pain perception
时间窗: at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
Evolution of pain (Visual Analogic Scale and the Modified Laitinen Pain Questionnaire) between baseline, after the end of the protocol treatment, 3 and 12 months after the end of the protocol treatment
次要结局
- Change in the quality of life(at baseline, immediately after treatment completion, 3 and 12 months after treatment completion)
- Change in the range of motion(at baseline, immediately after treatment completion, 3 and 12 months after treatment completion)
- Change in the pressure pain(at baseline, immediately after treatment completion, 3 and 12 months after treatment completion)
研究者
Justyna Wyszyńska
Principal Investigator
University of Rzeszow