High-Intensity Laser Therapy (HILT) in Patients With Knee Osteoarthritis
Assessment of the Effectiveness of High-Intensity Laser Therapy (HILT) in the Treatment of Knee Osteoarthritis: A Randomized Placebo-Controlled Trial
1 other identifier
interventional
72
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2026
CompletedFirst Posted
Study publicly available on registry
June 22, 2026
CompletedStudy Start
First participant enrolled
July 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
June 29, 2026
June 1, 2026
8 months
June 16, 2026
June 24, 2026
Conditions
Keywords
Outcome Measures
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.
Baseline, immediately after the 2-week intervention, and 8 weeks after completion of treatment.
Study Arms (2)
Conventional Physiotherapy + HILT
EXPERIMENTALConventional Physiotherapy + Sham HILT
SHAM COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Radiographically confirmed knee osteoarthritis
- Mild-to-moderate disease severity
- Pain ≥4 on VAS for at least 3 months
- Ability to participate in physiotherapy
- Informed consent
You may not qualify if:
- Advanced OA requiring surgery
- Previous knee arthroplasty
- Knee instability
- Acute inflammation
- Neurological disorders affecting gait
- Neuropathies or myopathies
- Active inflammatory arthritis
- Recent lower-limb injury (\<6 months)
- Intra-articular injections within 3 months
- Cancer, pregnancy, epilepsy
- Electronic implants or pacemaker
- Active local infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 16, 2026
First Posted
June 22, 2026
Study Start
July 3, 2026
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
June 29, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share