Osteoarthitis, Osteoarthritis (OA) of the Knee
Conditions
Keywords
High Intensity Laser Therapy, Knee Osteoarthritis, Femoral Cartilage Thickness, High Level Laser Therapy, Osteoarthritis
Brief summary
This clinical trial will evaluate the effects of High-Intensity Laser Therapy (HILT) on femoral cartilage thickness and other clinical outcomes in people with knee osteoarthritis. Participants aged 40 to 60 years with grade II or III knee osteoarthritis will be randomly assigned to receive either HILT plus conventional physiotherapy or conventional physiotherapy alone. Both groups will receive 12 treatment sessions on alternate days for 4 weeks. The study will assess changes in cartilage thickness using ultrasound, as well as improvements in pain, knee movement, muscle strength, and daily function. Findings from this research may help improve physiotherapy treatment strategies for patients with knee osteoarthritis.
Interventions
HILT will be administered using a Class IV laser applied perpendicularly at eight standardized knee points. Both analgesic and biostimulation modes will be used.. Sessions will be conducted on alternate days for 4 weeks (12 sessions total).
Conventional physiotherapy includes hot moist pack application, manual joint mobilization, stretching, and strengthening exercises for quadriceps and hamstrings. Sessions will be held on alternate days for 4 weeks (12 sessions total).
Sponsors
Study design
Masking description
This is a single-blind study. The outcome assessor will be blinded to group allocation, while the participants and treating physiotherapist will be aware of the intervention assigned
Intervention model description
Participants will be randomly assigned into two parallel groups: one receiving High-Intensity Laser Therapy (HILT) plus conventional physiotherapy, and the other receiving conventional physiotherapy alone. Each group will receive 12 treatment sessions on alternate days for 4 weeks.
Eligibility
Inclusion criteria
* Male and female participants aged 40-60 years. * Diagnosed with knee osteoarthritis (Kellgren-Lawrence grade II or III). * Knee pain for at least 3 months. * Visual Analogue Scale (VAS) score ≥ 3. * Willing to provide written informed consent and comply with treatment and follow-up schedule.
Exclusion criteria
* History of knee surgery or traumatic knee injury. * Inflammatory arthritis (e.g., gout, psoriatic arthritis). * History of cancer or psychiatric illness. * Cognitive disorders (e.g., Parkinson's disease, Alzheimer's disease). * Severe comorbidities limiting exercise (e.g., severe COPD, heart failure, cerebrovascular event). * Hip or ankle joint disability. * Intra-articular knee injection within the past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Femoral Cartilage Thickness | Baseline, Week 4 | Mean change in femoral cartilage thickness (mm) measured by high-frequency musculoskeletal ultrasound at three standardized sites - medial femoral condyle, intercondylar notch, and lateral femoral condyle. The measurement will be performed using a 7-12 MHz linear probe following standardized scanning protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Baseline, Week 2, Week 4 | Change in pain intensity will be measured using the Visual Analogue Scale (VAS), a 10-centimeter horizontal scale ranging from 0 to 10, where 0 will represent 'no pain' and 10 will represent the 'worst imaginable pain.' Higher scores will indicate worse pain. |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Baseline, Week 2, Week 4 | The Western Ontario and McMaster Universities Arthritis Index measures pain and functional disability and contains 24 questions: 5 for pain, 2 for joint stiffness, and 17 for physical function. Each item is scored qualitatively as none, low, moderate, severe, or very severe, with equivalent numerical scores of 0, 1, 2, 3, and 4. Higher scores indicate a greater negative effect on quality of life |
| Knee Range of Motion (ROM) | Baseline, Week 2, Week 4 | Active knee flexion and extension measured using a universal goniometer. Flexion is normally up to approximately 135 degrees. Higher degrees of motion indicate better knee mobility. |
| One-Leg Stance Test | Baseline, Week 2, Week 4 | The participant will stand on one leg with hands on hips and the opposite knee flexed to approximately 90°, and the time maintained in this position will be recorded in seconds. Maintaining the stance for at least 10 seconds will be considered the minimum threshold for functional balance. A longer time will indicate better balance performance. |
| Quadriceps Muscle Strength | Baseline, Week 2, Week 4 | Change in quadriceps strength will be measured using Manual Muscle Testing (Oxford/MRC scale). Muscle strength will be graded on a scale from 0 to 5, where 0 represents no muscle contraction and 5 represents normal strength against full resistance. Higher scores will indicate better quadriceps strength |
Countries
Pakistan