Osteoarthritis, KneeHILT-ESCOANCT07859878
Efficacy of High-Intensity Laser Therapy in Early-Stage Symptomatic Knee Osteoarthritis
A study testing High-Intensity Laser Therapy (HILT) and Standardized Home Exercise Program in people with Osteoarthritis, Knee, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- High-Intensity Laser Therapy (HILT) and Standardized Home Exercise Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2025to 18 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
- Availability of bilateral weight-bearing knee radiographs in two views obtained within the preceding 6 months.
- Diagnosis of early symptomatic knee osteoarthritis according to the Italian Society of Rheumatology International Initiative (ESKOA) criteria.
- Ability to cooperate with the prescribed exercise program.
- Willingness to participate in the study and provision of informed consent.
- Age eligibility:
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- 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.
Who cannot join
- 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.
- History of knee surgery.
- Presence of inflammatory arthritis, including rheumatoid arthritis, psoriatic arthritis, or gouty arthritis.
- History of trauma within the preceding 6 months.
- Fixed knee flexion deformity greater than 10 degrees or varus/valgus deformity greater than 15 degrees.
- Referred pain originating from the lumbar spine or hip.
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- Neurological deficits affecting the lower extremities.
- 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.
- Presence of a cardiac pacemaker or metal implants.
- Pregnancy.
- History of malignancy, knee osteonecrosis, infectious disease, psychiatric illness, or bleeding diathesis.
- Epilepsy.
- Conditions impairing cooperation or communication, including language barriers, aphasia, marked affective disorders, or a history of severe psychiatric illness.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Medicine Hospital
Izmir, İzmir, 35100
About this study
Official title: Efficacy of High-Intensity Laser Therapy in Early-Stage Symptomatic Knee Osteoarthritis: A Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- High-Intensity Laser Therapy (HILT), Sham Laser Therapy, Standardized Home Exercise Program
- Keywords
- Early Symptomatic Knee Osteoarthritis, High-Intensity Laser Therapy, Exercise Therapy, Sham-Controlled Trial
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Laser Therapy (HILT)Device
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 TherapyDevice
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.
Standardized Home Exercise ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| HILT + Exercise | Experimental | 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. Receives: Device: High-Intensity Laser Therapy (HILT); Other: Standardized Home Exercise Program |
| Sham Laser + Exercise | Sham comparator | 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). Receives: Device: Sham Laser Therapy; Other: Standardized Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, immediately after the 2-week treatment period, and 3 months after baseline
Secondary outcomes (3)
Functional Status Assessed by Health Assessment Questionnaire (HAQ)
Functional status and activities of daily living were assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI). Scores range from 0 to 3, with higher scores indicating greater disability and poorer functional status.
Measured: 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)
Physical health-related quality of life was assessed using the Physical Component Summary (PCS) score of the 12-Item Short Form Health Survey (SF-12). Higher scores indicate better physical health-related quality of life.
Measured: 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)
Mental health-related quality of life was assessed using the Mental Component Summary (MCS) score of the 12-Item Short Form Health Survey (SF-12). Higher scores indicate better mental health-related quality of life.
Measured: Baseline, immediately after the 2-week treatment period, and 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start5 Jun 2025
- Primary completion18 Jan 2026
- Study completion18 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Simin Hepgüler, Ege University
- Investigators
- A.Simin Hepgüler, MD, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859878
- Sponsor's protocol ID
- EGE-PMR-HILT-2025-01
- Acronym
- HILT-ESCOA
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data may be made available from the corresponding author upon reasonable request, subject to ethical and institutional approval.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High-Intensity Laser Therapy in Early-Stage Symptomatic Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07859878
- Acronym / sponsor ID
- HILT-ESCOA / EGE-PMR-HILT-2025-01
- Conditions
- Osteoarthritis, Knee
- Keywords
- Early Symptomatic Knee Osteoarthritis, High-Intensity Laser Therapy, Exercise Therapy, Sham-Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 18 Jan 2026 (actual)
- Study completion
- 18 Jan 2026 (actual)
- First posted
- 6 Oct 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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HILT + Exercise | Experimental | Device: High-Intensity Laser Therapy (HILT), Other: Standardized Home Exercise ProgramParticipants 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. |
| Sham Laser + Exercise | Sham comparator | Device: Sham Laser Therapy, Other: Standardized Home Exercise ProgramParticipants 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). |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
- Body mass index (BMI) greater than 25 kg/m².
- Family history of knee osteoarthritis.
- Previous knee injury.
Key exclusion criteria (18 listed)
- 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.
- History of knee surgery.
- Presence of inflammatory arthritis, including rheumatoid arthritis, psoriatic arthritis, or gouty arthritis.
- History of trauma within the preceding 6 months.
- Fixed knee flexion deformity greater than 10 degrees or varus/valgus deformity greater than 15 degrees.
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 |
|---|---|---|
| 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 | HILT + Exercise |
| Sham Laser TherapySham 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. | Device | Sham Laser + Exercise |
| Standardized Home Exercise ProgramBoth 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. | Other | HILT + Exercise, Sham Laser + Exercise |
Primary outcome
Pain Intensity Assessed by Visual Analog Scale (VAS)
Time frame: Baseline, immediately after the 2-week treatment period, and 3 months after baseline
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.
Knee Symptoms and Physical Function Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline, immediately after the 2-week treatment period, and 3 months after baseline
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.
3 secondary outcomes
Functional Status Assessed by Health Assessment Questionnaire (HAQ)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, immediately after the 2-week treatment period, and 3 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. 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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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. This study is not recruiting at the moment.
A.Simin Hepgüler, MD principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Laser Therapy (HILT) and Standardized Home Exercise Program in people with Osteoarthritis, Knee, run by Ege University at 1 site in Turkey (Türkiye).
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 17 inclusion and 18 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: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Assessed by Visual Analog Scale (VAS) (time frame: Baseline, immediately after the 2-week treatment period, and 3 months after baseline). The study lists 2 primary outcomes in all. 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 8 Oct 2026.