HILT Dose Optimization for Knee Osteoarthritis Pain

Optimal High-Intensity Laser Therapy (HILT) Parameters for Pain and Function in Patients With Moderate Knee Osteoarthritis: A Randomized Controlled Trial

This study aims to find the best settings (dose) for High-Intensity Laser Therapy (HILT) to reduce pain and improve function in people with moderate knee osteoarthritis. Participants will be randomly assigned to receive one of three different doses of HILT (low, medium, or high) or a sham (placebo) laser treatment, three times a week for four weeks. The main outcomes measured will be changes in knee pain (using a pain scale) and knee function (using a questionnaire) from the beginning to the end of the 4-week treatment period.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Low-Dose High-Intensity Laser Therapy (10 J/cm²); Device: Medium-Dose High-Intensity Laser Therapy (15 J/cm²); Device: High-Dose High-Intensity Laser Therapy (20 J/cm²); Device: Sham High-Intensity Laser Therapy

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed ElMeligie, Ph.D; Phone Number: 01159880001; Email: mohamed.elmeligie@ahuc.edu.eg
• Study Contact Backup: Name: Ibrahim Zoheiry, Ph.D; Phone Number: 01277774949; Email: ibrahim.alzoheiry@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 12311
    • Recruiting
    • Faculty of Physical Therapy, Al Hayah University
    • Contact: Mohamed ElMeligie, Ph.D; Phone Number: +20 01159880001; Email: mohamed.elmeligie@ahuc.edu.eg

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Age between 45 and 75 years, inclusive. Clinical diagnosis of knee osteoarthritis according to American College of Rheumatology (ACR) criteria (knee pain plus at least 3 of 6: age >50, morning stiffness <30 min, crepitus, bony tenderness, bony enlargement, no palpable warmth).

Radiographic evidence of knee osteoarthritis corresponding to Kellgren-Lawrence grade II or III in the target knee.

Average knee pain intensity ≥ 4 on a 10-cm Visual Analogue Scale (VAS) during weight-bearing activities in the past week.

Willingness and ability to attend 3 sessions per week for 4 weeks and attend all assessment sessions.

Exclusion Criteria:

Previous surgery on the index knee (including arthroscopy within the last year or joint replacement).

Diagnosis of inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, gout).

Intra-articular corticosteroid or hyaluronic acid injection in the index knee within the last 3 months.

Clinically significant comorbidities that could interfere with participation or assessment (e.g., severe uncontrolled cardiovascular disease, severe pulmonary disease, significant neurological deficits affecting the lower limb).

Presence of skin conditions (e.g., infection, open wounds, eczema, photosensitivity disorders) in the area designated for laser treatment.

Current use of anticoagulant medication (e.g., warfarin, DOACs) due to potential risk, unless stable and cleared by physician. (Consider if this is truly necessary based on HILT mechanism).

History of cancer in the treatment area or active malignancy elsewhere. Known photosensitivity or use of photosensitizing medications. Pregnancy, planning pregnancy, or breastfeeding. Participation in another interventional clinical trial within the last 30 days. Inability to understand or communicate in the study language.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-Dose HILT (10 J/cm²); Participants receive High-Intensity Laser Therapy at a dosage of 10 J/cm² per treatment zone, 3 times per week for 4 weeks (12 sessions total).	Device: Low-Dose High-Intensity Laser Therapy (10 J/cm²); Application of HILT using an Nd:YAG laser (BTL-6000, 1064 nm). Delivered via continuous scanning technique (1 cm distance) to 5 zones (25 cm² each) covering anterior, medial, and lateral knee aspects. Target dose: 10 J/cm² per zone. Session frequency: 3x/week for 4 weeks (12 total). Session duration: 15-20 min. Administered by trained PTs in outpatient rehab. Skin temperature monitored.
Experimental: Medium-Dose HILT (15 J/cm²); Participants receive High-Intensity Laser Therapy at a dosage of 15 J/cm² per treatment zone, 3 times per week for 4 weeks (12 sessions total).	Device: Medium-Dose High-Intensity Laser Therapy (15 J/cm²); Application of HILT using an Nd:YAG laser (BTL-6000, 1064 nm). Delivered via continuous scanning technique (1 cm distance) to 5 zones (25 cm² each) covering anterior, medial, and lateral knee aspects. Target dose: 15 J/cm² per zone. Session frequency: 3x/week for 4 weeks (12 total). Session duration: 15-20 min. Administered by trained PTs in outpatient rehab. Skin temperature monitored.
Experimental: High-Dose HILT (20 J/cm²); Participants receive High-Intensity Laser Therapy at a dosage of 20 J/cm² per treatment zone, 3 times per week for 4 weeks (12 sessions total).	Device: High-Dose High-Intensity Laser Therapy (20 J/cm²); Application of HILT using an Nd:YAG laser (BTL-6000, 1064 nm). Delivered via continuous scanning technique (1 cm distance) to 5 zones (25 cm² each) covering anterior, medial, and lateral knee aspects. Target dose: 20 J/cm² per zone. Session frequency: 3x/week for 4 weeks (12 total). Session duration: 15-20 min. Administered by trained PTs in outpatient rehab. Skin temperature monitored.
Sham Comparator: Sham HILT; Participants receive a sham High-Intensity Laser Therapy procedure using the same device and application technique, but with no energy delivered, 3 times per week for 4 weeks (12 sessions total).	Device: Sham High-Intensity Laser Therapy; Sham procedure mimicking active HILT using the same Nd:YAG laser device (BTL-6000). Same setup, patient positioning, scanning technique over identical zones, and session duration/frequency (3x/week, 4 weeks, 15-20 min). Device powered on with visual/auditory cues active, but no laser energy emitted. Administered by trained PTs in outpatient rehab. Skin temperature monitored.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Knee Pain Intensity	Visual Analogue Scale (VAS) for Pain: Change from baseline in average knee pain over the past week, measured on a 10 cm horizontal VAS, where 0 cm = no pain and 10 cm = worst imaginable pain. Higher scores indicate worse pain. Minimal Clinically Important Difference (MCID) estimated at 1.25 cm.	Baseline (T0), Mid-treatment (T1 - after 6 sessions), Post-treatment (T2 - after 12 sessions), 3-month Follow-up (T3)
Change in Knee Osteoarthritis Symptoms and Function	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Change from baseline in the total WOMAC score (Likert scale version 3.1). The WOMAC assesses pain (5 items), stiffness (2 items), and physical function (17 items). Total score ranges from 0-96, with higher scores indicating worse symptoms/function.	Baseline (T0), Mid-treatment (T1), Post-treatment (T2), 3-month Follow-up (T3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Knee Range of Motion (Flexion and Extension)	Change from baseline in active knee flexion and extension range of motion, measured in degrees using a standard goniometer.	Baseline (T0), Post-treatment (T2), 3-month Follow-up (T3)
Change in Functional Mobility	Timed Up and Go Test (TUG). Change from baseline in the time (in seconds) taken to rise from a standard chair, walk 3 meters, turn, walk back, and sit down. Shorter times indicate better mobility.	Baseline (T0), Post-treatment (T2), 3-month Follow-up (T3)
Incidence of Adverse Events	Number, type, and severity of any adverse events (AEs) reported by participants or observed by study staff throughout the study duration, particularly those potentially related to HILT (e.g., skin irritation, burns, increased pain).	Throughout study participation (up to 3-month follow-up)

Collaborators and Investigators

• Sponsor: Al Hayah University In Cairo

Study record dates

Study Major Dates

• Study Start (Estimated): April 23, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: HILT-KOA-DOSE

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