Efficacy of Low-level Laser Therapy Associated With Russian Electrical Stimulation in Knee Osteoarthritis: a Randomized Controlled Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Functionality
研究概览
简要总结
Objectives: To investigate the effect of low-level laser therapy (LLLT) application combined with Russian Electrical Stimulation on pain, mobility, functionality, range of motion, muscular strength, and activity in patients with osteoarthritis of the knee.
Design: Randomized controlled double-blind study. Setting: Specialist Rehabilitation Services.
详细描述
ABSTRACT Objectives: To investigate the effect of low-level laser therapy (LLLT) application combined with Russian Electrical Stimulation on pain, mobility, functionality, range of motion, muscular strength, and activity in patients with osteoarthritis of the knee.
Design: Randomized controlled double-blind study. Setting: Specialist Rehabilitation Services. Participants: Eighty participants with knee osteoarthritis were randomized. Intervention: Participants were randomized into four groups: Group I (n=20; LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation), Group II (n=20; Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation), Group III (n=20; LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation), Group IV (n=20; Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation). The groups treated with LLLT received treatments with invisible infrared laser (904 nm, 3 Joules/point). The Placebo groups received identical treatment, but the infrared laser output was disabled. The sessions occurred three times a week.
Main outcome measures: The primary outcome was the change in knee pain and functionality (Lequesne). Secondary outcomes included change in mobility (8 meters and Timed Up and Go test), range of motion (goniometer), muscular strength (dynamometer), activity (Western Ontario and McMaster Universities Osteoarthritis questionnaire) and medication intake.
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)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •levels 2-4 according to Kellgren-Lawrence grade
- •aged 50-75 years
- •both genders
- •have knee pain and functional disability for at least three months
- •according to the criteria of the American College for Rheumatology.
排除标准
- •cancer, diabetes, symptomatic hip osteoarthritis, or used antidepressants, anti-inflammatory medications or anxiolytics during six months prior to enrolment.
结局指标
主要结局
Functionality
时间窗: 6 months from baseline (follow up)
Was measured using the Lequesne questionnaire (11 questions about pain, discomfort and function). Scores range from 0 to 24 (from 'no' to 'extremely severe' dysfunction).
Pain intensity
时间窗: 6 months from baseline (follow up)
numeric pain rating scale (0-10) with a minimal clinically important change of two points
次要结局
- Medication intake(6 months from baseline (follow up))
- Range of motion of the knees(6 months from baseline (follow up))
- Mobility and balance(6 months from baseline (follow up))
- Activity(6 months from baseline (follow up))
- Muscular strength(6 months from baseline (follow up))