Knee Osteoarthritis (Knee OA)NCT07661407
High-Intensity Laser Therapy (HILT) in Patients With Knee Osteoarthritis
A study testing Conventional Physiotherapy and High-Intensity Laser Therapy (HILT) in people with Knee Osteoarthritis (Knee OA), run by University of Rzeszow.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- Conventional Physiotherapy and High-Intensity Laser Therapy (HILT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 3 Jul 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Advanced OA requiring surgery
- Previous knee arthroplasty
- Knee instability
- Acute inflammation
- Neurological disorders affecting gait
- Neuropathies or myopathies
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis (Knee OA)
- Being tested
- Conventional Physiotherapy, High-Intensity Laser Therapy (HILT), Sham High-Intensity Laser Therapy
- Keywords
- High-Intensity Laser Therapy, HILT, Knee Osteoarthritis, Gonarthrosis, Physiotherapy, Pain, KOOS, Randomized Controlled Trial
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PhysiotherapyBehavioural
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.
High-Intensity Laser Therapy (HILT)Device
Also called ASA Laser HIRO 3.0, 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.
Sham High-Intensity Laser TherapyDevice
Also called Sham HILT, Placebo HILT
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physiotherapy + HILT | Experimental | Not described Receives: Behavioral: Conventional Physiotherapy; Device: High-Intensity Laser Therapy (HILT) |
| Conventional Physiotherapy + Sham HILT | Sham comparator | Not described Receives: Behavioral: Conventional Physiotherapy; Device: Sham High-Intensity Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately after the 2-week intervention, and 8 weeks after completion of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start3 Jul 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (Knee OA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paweł Nalborczyk, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661407
- Sponsor's protocol ID
- 41/03/2026
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of High-Intensity Laser Therapy (HILT) in the Treatment of Knee Osteoarthritis: A Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07661407
- Acronym / sponsor ID
- 41/03/2026
- Conditions
- Knee Osteoarthritis (Knee OA)
- Keywords
- High-Intensity Laser Therapy, HILT, Knee Osteoarthritis, Gonarthrosis, Physiotherapy, Pain, KOOS, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 3 Jul 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy + HILT | Experimental | Behavioral: Conventional Physiotherapy, Device: High-Intensity Laser Therapy (HILT) |
| Conventional Physiotherapy + Sham HILT | Sham comparator | Behavioral: Conventional Physiotherapy, Device: Sham High-Intensity Laser Therapy |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Advanced OA requiring surgery
- Previous knee arthroplasty
- Knee instability
- Acute inflammation
- Neurological disorders affecting gait
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional PhysiotherapyParticipants 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. | Behavioural | Conventional Physiotherapy + HILT, Conventional Physiotherapy + Sham HILT |
| High-Intensity Laser Therapy (HILT)Also: ASA Laser HIRO 3.0, HILTParticipants 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 | Conventional Physiotherapy + HILT |
| Sham High-Intensity Laser TherapyAlso: Sham HILT, Placebo HILTo 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. | Device | Conventional Physiotherapy + Sham HILT |
Primary outcome
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale Score
Time frame: Baseline, immediately after the 2-week intervention, and 8 weeks after completion of treatment.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physiotherapy and High-Intensity Laser Therapy (HILT) in people with Knee Osteoarthritis (Knee OA), run by University of Rzeszow.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paweł Nalborczyk, MSc PT (+48691219338, pnalborczyk@ur.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale Score (time frame: Baseline, immediately after the 2-week intervention, and 8 weeks after completion of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.