Effectiveness of Low-intensity Laser on Pain in Patients With Supraspinatus Tendinopathy. A Triple-Blind Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- intensity of pain.
研究概览
简要总结
Tendinopathy is an inflammatory process that occurs in and around the tendon when both are affected by a certain injury. In the case of the supraspinatus muscle it is one of the most frequent causes of shoulder pain. To test the efficacy of laser treatment in reducing shoulder pain caused by supraspinatus muscle tendinopathy. A randomized controlled clinical trial (RCT) was carried out in which a physiotherapy intervention was performed using therapeutic laser for three months, to observe the influence on the pain generated by supraspinatus muscle tendinopathy in the shoulder.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
triple blinding
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Score of 3 or higher on the VAS scale for the shoulder.
- •Adequate cognitive ability for comprehension.
- •Rotator cuff tendinopathy confirmed by ultrasound at the study center, either due to tendon inflammation, presence of hypoechoic areas, calcification, fibrillar disorganization, and/or neovascularization in the supraspinatus muscle.
- •Pain in the proximal lateral part of the arm that worsens with abduction.
排除标准
- •Contraindications specific to laser treatment (e.g., tumors, presence of pacemaker or defibrillator, pregnancy, etc.).
- •History of glenohumeral fracture and rheumatoid arthritis.
- •Rheumatic, neurological, or structural polymyalgia affecting the joint.
- •Previous surgeries.
- •Pregnant or breastfeeding women.
- •Taking anticoagulants or antiplatelet agents.
- •Diabetes mellitus.
- •Cardiac dysfunction.
- •Infiltrative and/or rehabilitative treatment in the two months prior to recruitment.
- •Pre-existing conditions associated with pain in the upper extremities. Difficulties with follow-up.
- •Depression.
- •Treatment with another intervention; during the study, they will not be able to undergo it.
研究组 & 干预措施
Laser treatment
Laser treatment on tendinophaty shoulder.
干预措施: Laser Group (Device)
Placebo Group
Placebo treatment on tendinophaty shoulder.
干预措施: Placebo Group (Device)
结局指标
主要结局
intensity of pain.
时间窗: 3 months
measured using the VAS scale, where 0 is the least possible pain and 10 is the greatest possible pain
Pain
时间窗: 3 months
measured using the VAS scale, where 0 is the least possible pain and 10 is the greatest possible pain
次要结局
- Range of motion(3 months)
- Patient quality of life(3 months)
研究者
Jorge Velazquez
Principal Investigator
Universidad Pontificia de Salamanca