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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
140
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.
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.
Faculty of Physical Therapy, Al Hayah University
Cairo, Egypt
RECRUITINGChange 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)
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)
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)
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)
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).
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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 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.
Time frame: Throughout study participation (up to 3-month follow-up)