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COMPLETED

NCT07859878

Efficacy of High-Intensity Laser Therapy in Early-Stage Symptomatic Knee Osteoarthritis

Sponsor: Ege University

View on ClinicalTrials.gov

Summary

This randomized, double-blind, sham-controlled clinical trial evaluated the effectiveness of high-intensity laser therapy (HILT) in patients with early-stage symptomatic knee osteoarthritis. A total of 39 participants were randomly assigned to receive either HILT combined with a standardized home exercise program or sham laser therapy combined with the same exercise program. Laser or sham treatment was administered over 10 weekday sessions during a two-week period. Participants were assessed at baseline, immediately after treatment, and at the three-month follow-up. Assessments included pain intensity, physical function, health-related quality of life, walking performance, knee range of motion, and muscle strength. The aim was to determine whether adding HILT to exercise provides additional clinical benefits compared with sham laser therapy combined with exercise.

Official title: Efficacy of High-Intensity Laser Therapy in Early-Stage Symptomatic Knee Osteoarthritis: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06-05

Completion Date

2026-01-18

Last Updated

2026-10-08

Healthy Volunteers

Conditions

Osteoarthritis, Knee

Interventions

DEVICE

High-Intensity Laser Therapy (HILT)

High-intensity laser therapy (HILT) was administered using a 1064-nm laser at a frequency of 20 Hz, with an energy density of 1530 mJ/cm² and a total energy of 3000 J per session. Treatment consisted of 10 sessions administered on consecutive weekdays over a two-week period. HILT was combined with a standardized home exercise program.

DEVICE

Sham Laser Therapy

Sham laser therapy was administered using the same treatment schedule and application procedure as the active HILT group, but without delivering therapeutic laser energy. Participants received 10 sham sessions over two consecutive weeks (five sessions per week), combined with the same standardized home exercise program.

OTHER

Standardized Home Exercise Program

Both groups received the same standardized home exercise program, including knee range-of-motion exercises (3 sets of 10-12 repetitions), static stretching exercises (3 repetitions with a 30-second hold), and isometric and isotonic strengthening exercises (3 sets of 10-12 repetitions). The exercise program was prescribed as a home-based intervention alongside the assigned laser or sham laser treatment.

Inclusion Criteria: * Inclusion Criteria: 1. Patients presenting to the Physical Medicine and Rehabilitation outpatient clinics of Ege University Faculty of Medicine Hospital with knee pain lasting no longer than 6 months and a Visual Analog Scale (VAS) pain score of at least 4. 2. Availability of bilateral weight-bearing knee radiographs in two views obtained within the preceding 6 months. 3. Diagnosis of early symptomatic knee osteoarthritis according to the Italian Society of Rheumatology International Initiative (ESKOA) criteria. 4. Ability to cooperate with the prescribed exercise program. 5. Willingness to participate in the study and provision of informed consent. 6. Age eligibility: * 40-49 years: Presence of at least one of the following risk factors for early symptomatic knee osteoarthritis. * 50-75 years: Eligible regardless of the presence of the listed risk factors. Risk factors: * Body mass index (BMI) greater than 25 kg/m². * Family history of knee osteoarthritis. * Previous knee injury. * Lower-limb alignment abnormality. * Lower-limb length discrepancy. * Osteoarthritis at other anatomical sites. * Metabolic syndrome. * Difficulty initiating brisk walking or running after a period of inactivity. Exclusion Criteria: 1. Receipt of an intra-articular knee injection or physical therapy within the preceding 6 months, or use of natural health products such as glucosamine or chondroitin. 2. History of knee surgery. 3. Presence of inflammatory arthritis, including rheumatoid arthritis, psoriatic arthritis, or gouty arthritis. 4. History of trauma within the preceding 6 months. 5. Fixed knee flexion deformity greater than 10 degrees or varus/valgus deformity greater than 15 degrees. 6. Referred pain originating from the lumbar spine or hip. 7. Neurological deficits affecting the lower extremities. 8. Medical conditions that could prevent participation in the exercise program or completion of the study, including: * Myocardial infarction or cerebrovascular event within the preceding 3 months. * Congestive heart failure. * Severe chronic obstructive pulmonary disease. * History of myocardial ischemia during treadmill testing. * History of arterial or venous circulatory disorders. 9. Presence of a cardiac pacemaker or metal implants. 10. Pregnancy. 11. History of malignancy, knee osteonecrosis, infectious disease, psychiatric illness, or bleeding diathesis. 12. Epilepsy. 13. Conditions impairing cooperation or communication, including language barriers, aphasia, marked affective disorders, or a history of severe psychiatric illness.

Locations (1)

Ege University Faculty of Medicine Hospital

Izmir, İzmir, Turkey (Türkiye)