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NOT YET RECRUITING
NCT07661407
NA

High-Intensity Laser Therapy (HILT) in Patients With Knee Osteoarthritis

Sponsor: University of Rzeszow

View on ClinicalTrials.gov

Summary

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.

Official title: Assessment of the Effectiveness of High-Intensity Laser Therapy (HILT) in the Treatment of Knee Osteoarthritis: A Randomized Placebo-Controlled Trial

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2026-07-03

Completion Date

2028-03-31

Last Updated

2026-06-29

Healthy Volunteers

No

Interventions

BEHAVIORAL

Conventional Physiotherapy

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.

DEVICE

High-Intensity Laser Therapy (HILT)

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.

DEVICE

Sham High-Intensity Laser Therapy

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.