HILT Dose Optimization for Knee Osteoarthritis Pain

Al Hayah University In Cairo

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Device: Medium-Dose High-Intensity Laser Therapy (15 J/cm²); Device: High-Dose High-Intensity Laser Therapy (20 J/cm²); Device: Low-Dose High-Intensity Laser Therapy (10 J/cm²); Device: Sham High-Intensity Laser Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06916676

HILT-KOA-DOSE

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 4 patient groups

Low-Dose HILT (10 J/cm²)

Experimental group

Description:

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).

Treatment:

Device: Low-Dose High-Intensity Laser Therapy (10 J/cm²)

Medium-Dose HILT (15 J/cm²)

Experimental group

Description:

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).

Treatment:

Device: Medium-Dose High-Intensity Laser Therapy (15 J/cm²)

High-Dose HILT (20 J/cm²)

Experimental group

Description:

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).

Treatment:

Device: High-Dose High-Intensity Laser Therapy (20 J/cm²)

Sham HILT

Sham Comparator group

Description:

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).

Treatment:

Device: Sham High-Intensity Laser Therapy