About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
High-Intensity Laser Therapy (HILT)
DeviceHigh-Intensity Laser Therapy (HILT) combined with therapeutic exercise program. HILT Specifications: * Four-wavelength beam system for deep tissue penetration * Continuous and modulating frequencies to promote pain control and healing * SuperPulse mode for deeper therapeutic penetration * High power output delivering larger doses with shorter treatment times * Pre-programmed presets for consistent and safe treatment outcomes Mechanism of Action: HILT delivers high energy output into tissues, generating photochemical effects including: * Increased mitochondrial oxidation and ATP production * Enhanced blood circulation and metabolism * Fast absorption of edema and removal of exudates * Increased serotonin and endorphin levels * Anti-inflammatory effects through reduced prostaglandin synthesis * Decreased nerve cell membrane permeability for Na/K causing hyperpolarization * Increased lymphatic flow * Modulation of genetic markers: increased expression of cartilage protection biomarkers
Conventional Physical Therapy Modalities
DeviceClassical Physical Modalities combined with therapeutic exercise program. Modalities Include: * Therapeutic Ultrasound and/or other conventional physical therapy modalities as per standard clinical practice for knee osteoarthritis * Evidence-based parameters for knee OA treatment Treatment Protocol: * Duration: 8 weeks * Combined with the same standardized therapeutic exercise program as the HILT group * Sessions will be conducted at rheumatology and rehabilitation units in Erbil, Iraq This represents the current standard of care for conservative management of knee osteoarthritis in physical medicine and rehabilitation settings.
Treatment groups
Trial outcomes
Primary outcomes
Change in Pain Intensity (WOMAC Pain Subscale)
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.
Secondary outcomes
Change in Pain Intensity (Visual Analog Scale - VAS)
Pain intensity will be measured using a 100 mm Visual Analog Scale (VAS) for global pain or walking pain. Patients mark their pain level on a 100 mm line where 0 represents "no pain" and 100 represents "worst pain imaginable."
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