Rehabilitation of Knee Osteoarthritis by High Intensity Laser Therapy vs Classical Modalities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity (WOMAC Pain Subscale)
研究概览
简要总结
This study aims to compare the effectiveness and safety of High-Intensity Laser Therapy (HILT) with conventional physical therapy treatments in patients with knee osteoarthritis. Knee osteoarthritis is a common condition, especially in older adults, causing pain, stiffness, reduced movement, and difficulty performing daily activities. Current treatments focus on reducing pain and improving joint function.
In this study, 100 patients with knee osteoarthritis will be divided into two groups. One group will receive HILT combined with therapeutic exercises, while the other group will receive conventional physical therapy modalities along with the same exercises. The treatment outcomes will be evaluated over time.
The main outcomes include pain reduction (measured by pain scales such as WOMAC and VAS), improvement in joint function, and structural changes in the knee assessed by MRI. In addition, laboratory tests will be used to measure inflammation, cartilage health markers, and oxidative stress before and after treatment.
The goal is to determine whether HILT provides better pain relief, improves joint function, and is safe compared to standard therapy. The results may help improve rehabilitation strategies for patients with knee osteoarthritis.
详细描述
Knee Osteoarthritis is a chronic degenerative joint disorder characterized by progressive cartilage loss, pain, stiffness, and functional limitation. It is a leading cause of disability, particularly among older adults, and its prevalence is increasing with population aging.
Non-surgical management is the first-line approach and includes exercise therapy and physical modalities aimed at reducing pain and improving joint function. High-Intensity Laser Therapy is a non-invasive modality that delivers high-energy light to tissues, promoting cellular activity, increasing adenosine triphosphate (ATP) production, enhancing microcirculation, and reducing inflammation and edema. In contrast, Low-Level Laser Therapy has been more extensively studied, while evidence regarding HILT remains limited.
This study is a randomized comparative trial designed to evaluate the efficacy and safety of HILT compared with conventional physical therapy modalities in patients with knee osteoarthritis. A total of 100 participants meeting the American College of Rheumatology criteria will be recruited from rheumatology and rehabilitation centers in Erbil, Iraq. Participants will be randomly assigned to one of two groups: (1) HILT combined with therapeutic exercise, or (2) conventional physical therapy modalities combined with therapeutic exercise.
The primary outcome is pain intensity at 4 weeks, assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale or Visual Analogue Scale (VAS). Secondary outcomes include pain at 8 weeks and functional status. Structural joint changes will be evaluated using magnetic resonance imaging (MRI), including assessment of cartilage thickness, joint irregularity, effusion, and osteophyte formation.
Laboratory assessments will be conducted before and after intervention to evaluate biological effects. These include inflammatory markers (C-reactive protein), gene expression markers related to cartilage metabolism (TGFB1, FOXO1, COMP, and MMP3) measured by RT-PCR, and oxidative stress markers (malondialdehyde [MDA] and superoxide dismutase [SOD]) measured using ELISA.
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
- None
盲法说明
N/A - This is an open-label study with no masking.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of Knee Osteoarthritis: Patients must have a clinical and radiographic diagnosis of knee OA according to the American College of Rheumatology (ACR) criteria, including evidence of joint space narrowing, osteophyte formation, and other degenerative changes observed on X-rays or MRI.
- •Age: Adults aged between 40 and 75 years. Willingness to Participate: Participants must provide informed consent and be willing to adhere to the study protocol, including attending all treatment sessions and follow-up assessments.
- •Kellgren-Lawrence Grade: Patients with knee OA grades 1-3 (mild to moderate OA).
排除标准
- •Contraindications to Laser Therapy:
- •Active malignancy History of epilepsy Photosensitivity disorders Active infection in the treatment area
- •Surgical History:
- •Patients who have undergone knee surgery within the past 6 months Scheduled surgery during the study period
- •Advanced Disease:
- •Kellgren-Lawrence Grade 4 (severe OA) where surgical intervention is indicated
- •Pregnancy or Lactation:
- •Pregnant or lactating women
- •Severe Comorbidities:
- •Uncontrolled diabetes Severe cardiovascular disease Neurological disorders that might interfere with participation or affect treatment outcomes
研究组 & 干预措施
Experimental Group (HILT)
Patients will receive High-Intensity Laser Therapy (HILT) combined with a standardized therapeutic exercise program. HILT parameters include four-wavelength beam, continuous/modulating frequencies, and SuperPulse mode for deep penetration.
干预措施: High-Intensity Laser Therapy (HILT) (Device)
Experimental Group (HILT)
Patients will receive High-Intensity Laser Therapy (HILT) combined with a standardized therapeutic exercise program. HILT parameters include four-wavelength beam, continuous/modulating frequencies, and SuperPulse mode for deep penetration.
干预措施: Conventional Physical Therapy Modalities (Device)
Classical Modalities
Patients will receive classical physical modalities (such as therapeutic ultrasound or TENS, as per standard local practice) combined with the same standardized therapeutic exercise program.
干预措施: High-Intensity Laser Therapy (HILT) (Device)
Classical Modalities
Patients will receive classical physical modalities (such as therapeutic ultrasound or TENS, as per standard local practice) combined with the same standardized therapeutic exercise program.
干预措施: Conventional Physical Therapy Modalities (Device)
结局指标
主要结局
Change in Pain Intensity (WOMAC Pain Subscale)
时间窗: Baseline to 4 weeks post-treatment initiation
Pain intensity will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. The WOMAC is a validated instrument that measures pain, stiffness, and physical function in patients with osteoarthritis. The pain subscale consists of 5 items scored on a 0-10 scale, with higher scores indicating more severe pain.
次要结局
- Change in Pain Intensity (Visual Analog Scale - VAS)(Baseline to 4 weeks post-treatment initiation)
研究者
Mahdi Qadir
Lecturer
Erbil Polytechnic University