Effect of High-Intensity Laser Therapy on Femoral Cartilage in Knee Osteoarthritis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorUniversity of Lahore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-Intensity Laser Therapy (HILT) + Conventional Physiotherapy

    Device

    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

    Other intervention

    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).

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: High-Intensity Laser Therapy (HILT) + Conventional PhysiotherapyExperimental treatment 1 intervention
Group B: Conventional PhysiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Femoral Cartilage Thickness

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

Time frame
Baseline, Week 4

Secondary outcomes

1

Pain Intensity

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.

Time frame
Baseline, Week 2, Week 4
2

Western Ontario and McMaster Universities Arthritis Index (WOMAC)

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

Time frame
Baseline, Week 2, Week 4
3

Knee Range of Motion (ROM)

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.

Time frame
Baseline, Week 2, Week 4
4

One-Leg Stance Test

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.

Time frame
Baseline, Week 2, Week 4

Other outcomes

Sponsors and contacts

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