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

June 16, 2026 updated by: Paweł Nalborczyk, University of Rzeszow

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Knee osteoarthritis is one of the leading causes of pain and disability among older adults. Although physiotherapy constitutes a cornerstone of conservative management, the clinical effectiveness of High-Intensity Laser Therapy remains uncertain due to methodological heterogeneity of available studies. This prospective randomized placebo-controlled trial will evaluate whether HILT provides additional benefits when combined with standard physiotherapy.

Participants aged 40-75 years with radiographically confirmed mild-to-moderate knee osteoarthritis and pain intensity of at least 4 points on the Visual Analogue Scale will be enrolled. Participants will be randomly assigned in a 1:1 ratio using block randomization. The intervention period will last two weeks. Both groups will receive the same physiotherapy programme consisting of aerobic, strengthening, balance, proprioceptive, stretching, gait and functional exercises. The experimental group will receive active HILT, whereas the control group will receive sham HILT.

Assessments will be performed at baseline, immediately after treatment and 8 weeks after treatment completion.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional Physiotherapy + HILT
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.
Other Names:
  • HILT
  • ASA Laser HIRO 3.0
Sham Comparator: Conventional Physiotherapy + Sham HILT
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: 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.
Other Names:
  • Sham HILT
  • Placebo HILT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in KOOS Pain Subscale Score
Time Frame: Baseline, immediately after the 2-week intervention, and 8 weeks after completion of treatment.
Baseline, immediately after the 2-week intervention, and 8 weeks after completion of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rzeszow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 3, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 41/03/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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