Effect of High-Intensity Laser Therapy on Femoral Cartilage in Knee Osteoarthritis (HILT-KOA)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis (OA) of the Knee; Osteoarthitis
• Intervention / Treatment: Device: High-Intensity Laser Therapy (HILT) + Conventional Physiotherapy; Other: Conventional Physiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iqra Waseem, Ph.D Scholar; Phone Number: +923347779399; Email: iqra.waseem91@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 55000
      • London Aesthetics and Rejuvenation Center
      • Contact: Ayesha Malik, MS; Phone Number: 03047779396; Email: ayeshabutt031@gmail.com
      • Contact: Ishaq Ahmed, Ph.D. Physical Therapy; Phone Number: 03344066463; Email: ishaq.ahmed@uipt.uol.edu.pk
      • Principal Investigator: Iqra Waseem, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-Intensity Laser Therapy (HILT) + Conventional Physiotherapy; Participants in this group will receive High-Intensity Laser Therapy (HILT) using a Class IV laser (1064 nm wavelength) applied at eight standardized knee points according to WALT guidelines, along with conventional physiotherapy including hot moist pack, joint mobilization, and strengthening exercises. Treatment will be given on alternate days for 4 weeks (12 sessions total).	Device: High-Intensity Laser Therapy (HILT) + Conventional Physiotherapy; 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).
Active Comparator: Conventional Physiotherapy; Participants in this group will receive only conventional physiotherapy, including hot moist pack, patellofemoral and tibiofemoral joint mobilization, and a structured exercise program for quadriceps and hamstrings. Treatment will be given on alternate days for 4 weeks (12 sessions total).	Other: Conventional Physiotherapy; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 2, Week 4
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	Baseline, Week 2, Week 4
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.	Baseline, Week 2, Week 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.	Baseline, Week 2, Week 4
Quadriceps Muscle Strength	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	Baseline, Week 2, Week 4

Collaborators and Investigators

• Sponsor: University of Lahore

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): May 10, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee Osteoarthritis; High Intensity Laser Therapy; High Level Laser Therapy; Femoral Cartilage Thickness
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: UOL/IREB/25/12/0033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No