NCT02898025已完成不适用
Low Level Laser Therapy and Interferential Current in Patients With Knee Osteoarthritis: Randomized Controlled Trial
Universidade Cidade de Sao Paulo2 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2015年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Pain intensity measured by a numeric pain scale ranging from 0 to 10.
研究概览
简要总结
This study aims to evaluate the effectiveness of the low level laser therapy and interferential current in 168 patients with knee osteoarthritis
详细描述
Interventional
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of osteoarthritis of the knee characterized by pain of mild or moderate intensity
- •Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria
- •Patients with knee osteoarthritis (s) according to the ACR criteria
- •VAS 3 to 8
- •5 to 12 Lequesne
- •No complaint of pain in other joints of the lower limbs
- •Without neurological and cognitive disorders
- •No loss of sensation in the lower limbs
- •No surgery on the knee (s) in the last 6 months
- •Pain symptoms for at least 6 months
- •No infiltrations (s) knee (s) in the last 4 weeks
- •No use of analgesics 4 hours before treatment
排除标准
- •Individuals younger than 18 and older than 80 years
- •Complaints from other diseases of the lower limbs, knee prosthesis and / or hip joint instabilities and / or surgery in lower limbs, heart disease, uncontrolled hypertension and diabetes, coagulation disorders in anticoagulant therapy, pregnant women, fibromyalgia and individuals who can not perform isokinetic test who have difficulty performing the TUG, and those that are experiencing abnormal sensitivity to algometry
结局指标
主要结局
Pain intensity measured by a numeric pain scale ranging from 0 to 10.
时间窗: 4 weeks
Pressure Pain Threshold measured by a pressure algometer. Pressure will be recorded in kPa.
时间窗: 4 weeks
次要结局
- TUG (Timed Up & Go Test)(Measure at baseline, 4 weeks, 3 months, 6 months)
- WOMAC (Western Ontario and McMaster Universities Arthritis Index)(Measure at baseline, 4 weeks, 3 months, 6 months)
- Isokinetic Muscle Assessment(Measure at baseline, 4 weeks, 3 months, 6 months)
- LeQuesne Questionnaire(Measure at baseline, 4 weeks, 3 months, 6 months)
研究者
Richard Eloin Liebano
Principal Investigator
Universidade Cidade de Sao Paulo
研究点 (2)
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