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NCT Number: NCT07584603

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

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.

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Key information

Conditions

Osteoarthritis (OA) of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthitis Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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).

Primary outcomes

  1. Femoral Cartilage Thickness

    Time frame: 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 outcomes

  1. Pain Intensity

    Time frame: 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.

  2. Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Time frame: 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

  3. Knee Range of Motion (ROM)

    Time frame: 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.

  4. One-Leg Stance Test

    Time frame: 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.

  5. Quadriceps Muscle Strength

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Iqra Waseem, Ph.D Scholar

CONTACT

[email protected]

+923347779399

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

The Role of High-intensity Laser Therapy on Femoral Cartilage Thickness in Patients With Knee Osteoarthritis

Acronym: HILT-KOA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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