This randomized placebo-controlled trial aims to evaluate the effectiveness of High-Intensity Laser Therapy (HILT) as an adjunct to standard outpatient physiotherapy in patients with knee osteoarthritis. Seventy-two participants will be randomly assigned to receive either conventional physiotherapy combined with active HILT or conventional physiotherapy combined with sham HILT. Outcomes related to pain, knee function, physical performance, muscle strength, range of motion, psychosocial factors, quality of life and body composition will be assessed at baseline, after the intervention, and at 8-week follow-up.
Knee osteoarthritis is one of the leading causes of pain and disability among older adults. Although physiotherapy constitutes a cornerstone of conservative management, the clinical effectiveness of High-Intensity Laser Therapy remains uncertain due to methodological heterogeneity of available studies. This prospective randomized placebo-controlled trial will evaluate whether HILT provides additional benefits when combined with standard physiotherapy. Participants aged 40-75 years with radiographically confirmed mild-to-moderate knee osteoarthritis and pain intensity of at least 4 points on the Visual Analogue Scale will be enrolled. Participants will be randomly assigned in a 1:1 ratio using block randomization. The intervention period will last two weeks. Both groups will receive the same physiotherapy programme consisting of aerobic, strengthening, balance, proprioceptive, stretching, gait and functional exercises. The experimental group will receive active HILT, whereas the control group will receive sham HILT. Assessments will be performed at baseline, immediately after treatment and 8 weeks after treatment completion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Participants will receive a standardized outpatient physiotherapy programme delivered five times per week for two consecutive weeks. Each session will include aerobic exercise on a stationary bicycle, strengthening exercises, balance and proprioceptive training, functional exercises, stretching exercises, postural exercises, and gait training. The physiotherapy programme will be identical in both study groups.
Participants will receive High-Intensity Laser Therapy using the ASA Laser HIRO 3.0 device (3 kW). Treatment will be administered three times per week for two consecutive weeks, resulting in six treatment sessions. Laser irradiation will be delivered in pulsed mode at a frequency of 20 Hz with a total energy dose of 3000 J per session. The laser will be applied using a dynamic scanning technique over the anterior, medial, and lateral aspects of the affected knee joint and selected periarticular trigger points. All procedures will be performed according to a standardized treatment protocol.
o Participants will undergo a sham High-Intensity Laser Therapy procedure using the same ASA Laser HIRO 3.0 device and treatment schedule as the active intervention group. The handpiece will be positioned and moved over the treatment area in the same manner as during active treatment; however, no therapeutic laser energy will be delivered. The device will not emit laser radiation, light signals, or audible treatment sounds. Session frequency, duration, therapist-patient interaction, and treatment environment will be identical to those of the active HILT group.
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale Score
The Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale assesses knee pain using 9 items. Scores are transformed to a 0-100 scale, where 0 represents extreme knee pain and 100 represents no knee pain. Therefore, higher scores indicate a better outcome (less pain). The primary endpoint is the change in KOOS Pain subscale score from baseline.
Time frame: Baseline, immediately after the 2-week intervention, and 8 weeks after completion of treatment.
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