Additional Effect of High-Intensity Laser Therapy Over Conventional Physiotherapy Related to Pain and Function in Patients With Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled, 12-Week Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- The Visual Analog Scale (VAS)
研究概览
简要总结
The aim of this prospective, randomized, double-blinded study is to investigate the additional benefits of high-intensity laser therapy (HILT) over conventional physiotherapy, related to pain and function, in patients with knee osteoarthritis (KOA).
详细描述
The study was performed in Baskent University Physical Therapy and Rehabilitation Unit. 43 patients of both sexes, who were diagnosed clinical and radiographic knee osteoarthritis, with Kellgren Lawrence Grade 2 and 3, were randomly assigned in two groups. Group 1 (n = 21) received TENS, HP, exercises (EX), and High-Intensity Laser Therapy (HILT; Nd:yag laser, 10W). Group 2 (n = 22) received the same interventions but placebo HILT. All interventions were applied for 10 sessions. The Visual Analog Scale (VAS), Western Ontario & McMaster Universities Osteoarthritis Questionnaire (WOMAC), and Lequesne Algofunctional Index (LAI) were performed before, after, and at 12-week follow-up.
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
Both the participants, investigators and outcomes assessors were blinded throughout the study.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •both sexes and age between 40 and 65;
- •pain at least 3 months on single or both knees
- •diagnosed as KOA with Kellgren Lawrence (KL) Grade 2 or 3 KOA on weight-bearing anteroposterior X-ray images
- •normal serum acute phase reactants and uric acid levels
- •had no major effusion in the joint.
排除标准
- •therapeutic joint injection in the last 6 months
- •physical therapy and/or HILT in the last 3 months
- •any surgical invention for the knee joint
- •malignancy in the last 5 years.
结局指标
主要结局
The Visual Analog Scale (VAS)
时间窗: 12 weeks
The VAS was assessed before treatment, at the end of 10 sessions, and at the 12 week follow-up. Min score was 0 and max score was 100. Higher scores on the VAS indicate greater pain.
次要结局
- Western Ontario & McMaster Universities Osteoarthritis Questionnaire (WOMAC)(12 weeks)
- Lequesne Algofunctional Index (LAI)(12 weeks)
研究者
Selen Özgözen
Clinical Doctor
Baskent University