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HILT Dose Optimization for Knee Osteoarthritis Pain

ConditionKnee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAl Hayah University In Cairo

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Device

    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.

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

    Device

    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.

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

    Device

    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 High-Intensity Laser Therapy

    Device

    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.

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: Low-Dose HILT (10 J/cm²)Experimental treatment 1 intervention
Group B: Medium-Dose HILT (15 J/cm²)Experimental treatment 1 intervention
Group C: High-Dose HILT (20 J/cm²)Experimental treatment 1 intervention
Group D: Sham HILTSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (T0), Mid-treatment (T1 - after 6 sessions), Post-treatment (T2 - after 12 sessions), 3-month Follow-up (T3)
2

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.

Time frame
Baseline (T0), Mid-treatment (T1), Post-treatment (T2), 3-month Follow-up (T3)

Secondary outcomes

1

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.

Time frame
Baseline (T0), Post-treatment (T2), 3-month Follow-up (T3)
2

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.

Time frame
Baseline (T0), Post-treatment (T2), 3-month Follow-up (T3)
3

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).

Time frame
Throughout study participation (up to 3-month follow-up)

Other outcomes

Sponsors and contacts

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Al Hayah University In Cairo

Lead sponsor

Source ClinicalTrials.gov
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