Assessment of the Effectiveness of High-Intensity Laser Therapy (HILT) in the Treatment of Knee Osteoarthritis: A Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale Score
研究概览
简要总结
This randomized placebo-controlled trial aims to evaluate the effectiveness of High-Intensity Laser Therapy (HILT) as an adjunct to standard outpatient physiotherapy in patients with knee osteoarthritis. Seventy-two participants will be randomly assigned to receive either conventional physiotherapy combined with active HILT or conventional physiotherapy combined with sham HILT. Outcomes related to pain, knee function, physical performance, muscle strength, range of motion, psychosocial factors, quality of life and body composition will be assessed at baseline, after the intervention, and at 8-week follow-up.
详细描述
Knee osteoarthritis is one of the leading causes of pain and disability among older adults. Although physiotherapy constitutes a cornerstone of conservative management, the clinical effectiveness of High-Intensity Laser Therapy remains uncertain due to methodological heterogeneity of available studies. This prospective randomized placebo-controlled trial will evaluate whether HILT provides additional benefits when combined with standard physiotherapy.
Participants aged 40-75 years with radiographically confirmed mild-to-moderate knee osteoarthritis and pain intensity of at least 4 points on the Visual Analogue Scale will be enrolled. Participants will be randomly assigned in a 1:1 ratio using block randomization. The intervention period will last two weeks. Both groups will receive the same physiotherapy programme consisting of aerobic, strengthening, balance, proprioceptive, stretching, gait and functional exercises. The experimental group will receive active HILT, whereas the control group will receive sham HILT.
Assessments will be performed at baseline, immediately after treatment and 8 weeks after treatment completion.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiographically confirmed knee osteoarthritis
- •Mild-to-moderate disease severity
- •Pain ≥4 on VAS for at least 3 months
- •Ability to participate in physiotherapy
- •Informed consent
排除标准
- •Advanced OA requiring surgery
- •Previous knee arthroplasty
- •Knee instability
- •Acute inflammation
- •Neurological disorders affecting gait
- •Neuropathies or myopathies
- •Active inflammatory arthritis
- •Recent lower-limb injury (<6 months)
- •Intra-articular injections within 3 months
- •Cancer, pregnancy, epilepsy
- •Electronic implants or pacemaker
- •Active local infection
研究组 & 干预措施
Conventional Physiotherapy + HILT
干预措施: High-Intensity Laser Therapy (HILT) (Device)
Conventional Physiotherapy + Sham HILT
干预措施: Conventional Physiotherapy (Behavioral)
Conventional Physiotherapy + HILT
干预措施: Conventional Physiotherapy (Behavioral)
Conventional Physiotherapy + Sham HILT
干预措施: Sham High-Intensity Laser Therapy (Device)
结局指标
主要结局
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale Score
时间窗: Baseline, immediately after the 2-week intervention, and 8 weeks after completion of treatment.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale assesses knee pain using 9 items. Scores are transformed to a 0-100 scale, where 0 represents extreme knee pain and 100 represents no knee pain. Therefore, higher scores indicate a better outcome (less pain). The primary endpoint is the change in KOOS Pain subscale score from baseline.
次要结局
未报告次要终点
研究者
Paweł Nalborczyk
Principal Investigator
University of Rzeszow