High-Intensity Laser Therapy (HILT) in Patients With Knee Osteoarthritis
ConditionKnee Osteoarthritis (Knee OA)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorUniversity of Rzeszow
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Radiographically confirmed knee osteoarthritis
Mild-to-moderate disease severity
Pain ≥4 on VAS for at least 3 months
Ability to participate in physiotherapy
Disqualifiers
Advanced OA requiring surgery
Previous knee arthroplasty
Knee instability
Acute inflammation
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional Physiotherapy
BehavioralParticipants 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.
High-Intensity Laser Therapy (HILT)
DeviceParticipants 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.
Sham High-Intensity Laser Therapy
Deviceo 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Conventional Physiotherapy + HILTExperimental treatment 2 interventions
Group B: Conventional Physiotherapy + Sham HILTSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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