NCT07859878|Completed
Efficacy of High-Intensity Laser Therapy in Early-Stage Symptomatic Knee Osteoarthritis
HILT-ESCOA
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HILT-ESCOA
Sponsor study identifier
interventional
39
1 country
1
Study Start
June 5, 2025
Actual (reported)Primary Completion
January 18, 2026
Actual (reported)Study Completion
January 18, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 18, 2026
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 5, 2025
Actual (reported)January 18, 2026
Actual (reported)January 18, 2026
Actual (reported)September 30, 2026
Actual (reported)October 6, 2026
Actual (reported)Pain Intensity Assessed by Visual Analog Scale (VAS)
Pain intensity was assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Baseline, immediately after the 2-week treatment period, and 3 months after baseline
Knee Symptoms and Physical Function Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Knee osteoarthritis-related symptoms and physical function were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), including pain, stiffness, and physical function subscales. Higher scores indicate greater symptom severity and functional impairment.
Baseline, immediately after the 2-week treatment period, and 3 months after baseline
Functional Status Assessed by Health Assessment Questionnaire (HAQ)
Baseline, immediately after the 2-week treatment period, and 3 months after baseline
Health-Related Quality of Life Assessed by Short Form Health Survey (SF-12) Physical Component Summary (PCS)
Baseline, immediately after the 2-week treatment period, and 3 months after baseline
Health-Related Quality of Life Assessed by Short Form Health Survey (SF-12) Mental Component Summary (MCS)
Baseline, immediately after the 2-week treatment period, and 3 months after baseline
Functional Exercise Capacity Assessed by 6-Minute Walk Test (6MWT)
Baseline, immediately after the 2-week treatment period, and 3 months after baseline
Knee Range of Motion (ROM)
Baseline, immediately after the 2-week treatment period, and 3 months after baseline
Lower Extremity Muscle Strength Assessed by Manual Muscle Testing (MMT)
Baseline, immediately after the 2-week treatment period, and 3 months after baseline
Participants received high-intensity laser therapy (HILT) combined with a standardized home exercise program. HILT was administered in 10 sessions over two consecutive weeks (five sessions per week). Participants also performed the prescribed home exercise program throughout the treatment period.
Participants received sham laser therapy combined with the same standardized home exercise program as the experimental group. The sham procedure was administered without therapeutic laser energy in 10 sessions over two consecutive weeks (five sessions per week).
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.
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.
Ege University Faculty of Medicine Hospital
Izmir, İzmir, 35100, Turkey (Türkiye)
A.Simin Hepgüler, MD
Ege University
39 participants (actual enrollment reported by the registry).
First Submitted
September 30, 2026
First Posted
October 6, 2026
Study Start
June 5, 2025
Actual (reported)Short Term Efficacy of High-intensity Laser Therapy in Patients With Knee Osteoarthritis
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.
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Primary Completion
January 18, 2026
Actual (reported)Study Completion
January 18, 2026
Actual (reported)Last Updated
October 8, 2026
Record last verified: 2026-10
De-identified individual participant data may be made available from the corresponding author upon reasonable request, subject to ethical and institutional approval.
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Source: ClinicalTrials.gov.
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