Osteoarthritic Knee PainHILT-KOANCT07630259
Effects of High-Intensity Laser Therapy Combined With Exercise in Patients With Knee Osteoarthritis
A study testing High Intensity Laser Therapy and Exercise in people with Osteoarthritic Knee Pain and Osteo Arthritis of the Knee, run by Universidad Metropolitana de Ciencias de la Educacion at 1 site in Chile.
Trial summary
The goal of this clinical trial was to determine whether high-intensity laser therapy (HILT) combined with exercise improves pain, physical function, and muscle strength in people with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 77 years
- Conditions the study is for
- Osteoarthritic Knee Pain, Osteo Arthritis of the Knee, Osteoarthitis
- What is being tested?
- High Intensity Laser Therapy and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteChile
- Study dates
- 29 Nov 2023to 26 Aug 2025
- 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 45 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of knee osteoarthritis.
- Age between 45 and 77 years.
- Pain intensity of at least 3 points on the Visual Analogue Scale (VAS).
Who cannot join
- Presence of other musculoskeletal conditions affecting the lower limbs.
- History of lower limb surgery.
- Tattoos in the laser application area.
- Recent intra-articular corticosteroid injection.
- Comorbidities limiting participation in physical exercise, such as chronic obstructive pulmonary disease, stroke, or severe heart failure.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Departamento de Kinesiología
Santiago, Santiago Metropolitan, 7760197
About this study
Official title: Effects of High-intensity Laser Therapy on Muscle Strength in People With Knee Osteoarthritis
The goal of this clinical trial was to determine whether high-intensity laser therapy (HILT) combined with exercise improves pain, physical function, and muscle strength in people with knee osteoarthritis.
The main questions the study aimed to answer were:
Read more
- Did HILT combined with exercise lower pain more than sham laser combined with exercise?
- Did HILT combined with exercise improve physical function more than sham laser combined with exercise?
- Did HILT combined with exercise improve knee extensor muscle strength more than sham laser combined with exercise?
Researchers compared HILT plus exercise with sham laser plus exercise to determine whether HILT provided additional benefits beyond those achieved with exercise alone.
Participants:
- Received either HILT or sham laser treatment for four weeks.
- Participated in a standardized exercise program.
- Completed assessments of pain, physical function, and muscle strength before and after treatment.
Read the detailed description
Knee osteoarthritis is a common musculoskeletal condition associated with pain, reduced physical function, and muscle weakness. Exercise therapy is widely recommended as a first-line treatment; however, the additional benefits of high-intensity laser therapy (HILT) remain uncertain. Previous studies have reported improvements in pain and function following HILT, but results have been inconsistent, and its effects on muscle strength have not been fully established.
The purpose of this randomized, participant-blinded, sham-controlled clinical trial was to evaluate the effects of HILT combined with exercise on pain, physical function, and knee extensor muscle strength in people with knee osteoarthritis.
Participants with clinically diagnosed knee osteoarthritis were randomly assigned to one of two groups. The experimental group received HILT combined with a standardized exercise program, while the control group received sham laser treatment combined with the same exercise program. The intervention lasted four weeks and included ten treatment sessions.
Pain intensity, physical function, and knee extensor muscle strength were assessed before and after the intervention using validated clinical outcome measures. The primary objective was to determine whether HILT provides additional benefits beyond those achieved with exercise alone.
The findings of this study may help clarify the role of HILT as an adjunct treatment in rehabilitation programs for people with knee osteoarthritis and contribute to the development of evidence-based clinical recommendations.
- Conditions
- Osteoarthritic Knee Pain, Osteo Arthritis of the Knee, Osteoarthitis, Osteoarthritis (OA) of the Knee, Osteoarthritis (Knee), Osteoarthritis in the Knee
- Being tested
- High Intensity Laser Therapy, Sham Laser, Exercise
- Keywords
- Knee Osteoarthritis, High Intensity Laser Therapy, HILT, Laser Therapy, Photobiomodulation, Pain, Excercise Therapy, Rehabilitation, Músculo Strength, Physical Function, Musculoskeletal Disorders, Randomized Controlled Trial
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Pain, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Laser TherapyDevice
Also called HILT, MLS Laser Therapy, Photobiomodulation, Laser Therapy
High-intensity laser therapy (HILT) was delivered using an MLS laser device (MPHI D, ASA Laser, Italy), which combines synchronized 808 nm and 905 nm wavelengths. Treatment was applied to four periarticular knee regions, including the medial and lateral patellar borders, the suprapatellar region, and the medial tibiofemoral joint line. Participants received 10 treatment sessions over four weeks. HILT was administered in combination with a standardized exercise program.
Sham LaserDevice
Also called Sham Laser Therapy, Placebo Laser, Sham High Intensity Laser Therapy
Sham laser treatment was delivered using the same laser device, treatment schedule, and application sites as the active intervention. Subtherapeutic parameters were used to mimic the treatment procedure while minimizing biological effects and maintaining participant blinding. Participants received 10 treatment sessions over four weeks in combination with the same standardized exercise program used in the experimental group.
ExerciseOther
Also called Therapeutic exercise, Exercise Program, Physical Therapy exercise, Rehabilitation exercise
The exercise program was performed during each treatment session and included strengthening, flexibility, and balance exercises targeting the lower extremities. Exercises included stationary cycling, hamstring and gastrocnemius stretching, straight-leg raises, knee extensions, heel raises, step-ups, and single-leg balance activities. The program was standardized for both study groups and was delivered over 10 sessions during a four-week period.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Laser Therapy + Exercise | Experimental | Participants received high-intensity laser therapy (HILT) combined with a standardized exercise program. HILT was delivered using an MLS laser device (MPHI D, ASA Laser, Italy) over four periarticular knee application points during 10 treatment sessions over four weeks. The exercise program included strengthening, flexibility, and balance exercises and was identical to that provided to the sham comparator group. Receives: Device: High Intensity Laser Therapy; Other: Exercise |
| Sham Laser + Exercise | Sham comparator | Participants received sham laser treatment combined with the same standardized exercise program used in the experimental group. Sham treatment was delivered using the same laser device and treatment schedule as the active intervention but with subtherapeutic parameters designed to maintain participant blinding. The intervention consisted of 10 treatment sessions over four weeks. The exercise program included strengthening, flexibility, and balance exercises. Receives: Device: Sham Laser; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Knee Extensor Muscle Strength After 4 Weeks of Treatment
Change in knee extensor muscle strength measured with a dynamometer. Results were expressed in Newtons (N). Higher values indicate greater muscle strength.
Measured: Baseline and Week 4
Secondary outcomes (2)
Change From Baseline in Pain Intensity After 4 Weeks of Treatment
Change in pain intensity measured using the Visual Analogue Scale (VAS). Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Measured: Baseline and Week 4
Change From Baseline in WOMAC Total Score After 4 Weeks of Treatment
Change in symptoms and functional status measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Higher scores indicate greater impairment.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start29 Nov 2023
- Primary completion26 Aug 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritic Knee PainStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Metropolitana de Ciencias de la Educacion
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Silva-Satlov, Universidad Metropolitana de Ciencias de la Educacion
- Investigators
- Ivan Patricio Silva-Satlov, Magister, Principal investigator, Universidad Metropolitana de Ciencias de la Educación
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630259
- Sponsor's protocol ID
- 422/2023
- Acronym
- HILT-KOA
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 5 Jun 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 underlying the results reported in publications arising from this study will be available upon reasonable request. Data that support the primary and secondary outcome analyses, including pain, functional status, and muscle strength measurements, may be shared after publication of the primary study results. Requests will be evaluated by the Principal Investigator and must include a scientifically sound research proposal. All shared data will be fully de-identified to protect participant confidentiality.
Publications
Jang S, Lee K, Ju JH. Recent Updates of Diagnosis, Pathophysiology, and Treatment on Osteoarthritis of the Knee. Int J Mol Sci. 2021 Mar 5;22(5):2619. doi: 10.3390/ijms22052619.
PubMed 33807695Siriratna P, Ratanasutiranont C, Manissorn T, Santiniyom N, Chira-Adisai W. Short-Term Efficacy of High-Intensity Laser Therapy in Alleviating Pain in Patients with Knee Osteoarthritis: A Single-Blind Randomised Controlled Trial. Pain Res Manag. 2022 Oct 21;2022:1319165. doi: 10.1155/2022/1319165. eCollection 2022.
PubMed 36313402Akaltun MS, Altindag O, Turan N, Gursoy S, Gur A. Efficacy of high intensity laser therapy in knee osteoarthritis: a double-blind controlled randomized study. Clin Rheumatol. 2021 May;40(5):1989-1995. doi: 10.1007/s10067-020-05469-7. Epub 2020 Oct 19.
PubMed 33074393Song HJ, Seo HJ, Kim D. Effectiveness of high-intensity laser therapy in the management of patients with knee osteoarthritis: A systematic review and meta-analysis of randomized controlled trials. J Back Musculoskelet Rehabil. 2020;33(6):875-884. doi: 10.3233/BMR-191738.
PubMed 32831189
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-intensity Laser Therapy on Muscle Strength in People With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07630259
- Acronym / sponsor ID
- HILT-KOA / 422/2023
- Conditions
- Osteoarthritic Knee Pain, Osteo Arthritis of the Knee, Osteoarthitis, Osteoarthritis (OA) of the Knee, Osteoarthritis (Knee), Osteoarthritis in the Knee
- Keywords
- Knee Osteoarthritis, High Intensity Laser Therapy, HILT, Laser Therapy, Photobiomodulation, Pain, Excercise Therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Universidad Metropolitana de Ciencias de la EducacionUniversity, hospital or other
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 5 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.
The goal of this clinical trial was to determine whether high-intensity laser therapy (HILT) combined with exercise improves pain, physical function, and muscle strength in people with knee osteoarthritis.
The main questions the study aimed to answer were:
- Did HILT combined with exercise lower pain more than sham laser combined with exercise?
- Did HILT combined with exercise improve physical function more than sham laser combined with exercise?
- Did HILT combined with exercise improve knee extensor muscle strength more than sham laser combined with exercise?
Researchers compared HILT plus exercise with sham laser plus exercise to determine whether HILT provided additional benefits beyond those achieved with exercise alone.
Participants:
- Received either HILT or sham laser treatment for four weeks.
- Participated in a standardized exercise program.
- Completed assessments of pain, physical function, and muscle strength before and after treatment.
Detailed description
Knee osteoarthritis is a common musculoskeletal condition associated with pain, reduced physical function, and muscle weakness. Exercise therapy is widely recommended as a first-line treatment; however, the additional benefits of high-intensity laser therapy (HILT) remain uncertain. Previous studies have reported improvements in pain and function following HILT, but results have been inconsistent, and its effects on muscle strength have not been fully established.
The purpose of this randomized, participant-blinded, sham-controlled clinical trial was to evaluate the effects of HILT combined with exercise on pain, physical function, and knee extensor muscle strength in people with knee osteoarthritis.
Participants with clinically diagnosed knee osteoarthritis were randomly assigned to one of two groups. The experimental group received HILT combined with a standardized exercise program, while the control group received sham laser treatment combined with the same exercise program. The intervention lasted four weeks and included ten treatment sessions.
Pain intensity, physical function, and knee extensor muscle strength were assessed before and after the intervention using validated clinical outcome measures. The primary objective was to determine whether HILT provides additional benefits beyond those achieved with exercise alone.
The findings of this study may help clarify the role of HILT as an adjunct treatment in rehabilitation programs for people with knee osteoarthritis and contribute to the development of evidence-based clinical recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Laser Therapy + Exercise | Experimental | Device: High Intensity Laser Therapy, Other: ExerciseParticipants received high-intensity laser therapy (HILT) combined with a standardized exercise program. HILT was delivered using an MLS laser device (MPHI D, ASA Laser, Italy) over four periarticular knee application points during 10 treatment sessions over four weeks. The exercise program included strengthening, flexibility, and balance exercises and was identical to that provided to the sham comparator group. |
| Sham Laser + Exercise | Sham comparator | Device: Sham Laser, Other: ExerciseParticipants received sham laser treatment combined with the same standardized exercise program used in the experimental group. Sham treatment was delivered using the same laser device and treatment schedule as the active intervention but with subtherapeutic parameters designed to maintain participant blinding. The intervention consisted of 10 treatment sessions over four weeks. The exercise program included strengthening, flexibility, and balance exercises. |
Who may qualify
- Ages
- 45 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of knee osteoarthritis.
- Age between 45 and 77 years.
- Pain intensity of at least 3 points on the Visual Analogue Scale (VAS).
Key exclusion criteria (5 listed)
- Presence of other musculoskeletal conditions affecting the lower limbs.
- History of lower limb surgery.
- Tattoos in the laser application area.
- Recent intra-articular corticosteroid injection.
- Comorbidities limiting participation in physical exercise, such as chronic obstructive pulmonary disease, stroke, or severe heart failure.
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 TherapyAlso: HILT, MLS Laser Therapy, Photobiomodulation, Laser TherapyHigh-intensity laser therapy (HILT) was delivered using an MLS laser device (MPHI D, ASA Laser, Italy), which combines synchronized 808 nm and 905 nm wavelengths. Treatment was applied to four periarticular knee regions, including the medial and lateral patellar borders, the suprapatellar region, and the medial tibiofemoral joint line. Participants received 10 treatment sessions over four weeks. HILT was administered in combination with a standardized exercise program. | Device | High Intensity Laser Therapy + Exercise |
| Sham LaserAlso: Sham Laser Therapy, Placebo Laser, Sham High Intensity Laser TherapySham laser treatment was delivered using the same laser device, treatment schedule, and application sites as the active intervention. Subtherapeutic parameters were used to mimic the treatment procedure while minimizing biological effects and maintaining participant blinding. Participants received 10 treatment sessions over four weeks in combination with the same standardized exercise program used in the experimental group. | Device | Sham Laser + Exercise |
| ExerciseAlso: Therapeutic exercise, Exercise Program, Physical Therapy exercise, Rehabilitation exerciseThe exercise program was performed during each treatment session and included strengthening, flexibility, and balance exercises targeting the lower extremities. Exercises included stationary cycling, hamstring and gastrocnemius stretching, straight-leg raises, knee extensions, heel raises, step-ups, and single-leg balance activities. The program was standardized for both study groups and was delivered over 10 sessions during a four-week period. | Other | High Intensity Laser Therapy + Exercise, Sham Laser + Exercise |
Primary outcome
Change From Baseline in Knee Extensor Muscle Strength After 4 Weeks of Treatment
Time frame: Baseline and Week 4
Change in knee extensor muscle strength measured with a dynamometer. Results were expressed in Newtons (N). Higher values indicate greater muscle strength.
2 secondary outcomes
Change From Baseline in Pain Intensity After 4 Weeks of Treatment
Time frame: Baseline and Week 4
Change From Baseline in WOMAC Total Score After 4 Weeks of Treatment
Time frame: Baseline and Week 4
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 5 Jun 2026.
- Background: PubMed 33807695Jang S, Lee K, Ju JH. Recent Updates of Diagnosis, Pathophysiology, and Treatment on Osteoarthritis of the Knee. Int J Mol Sci. 2021 Mar 5;22(5):2619. doi: 10.3390/ijms22052619.
- Background: PubMed 36313402Siriratna P, Ratanasutiranont C, Manissorn T, Santiniyom N, Chira-Adisai W. Short-Term Efficacy of High-Intensity Laser Therapy in Alleviating Pain in Patients with Knee Osteoarthritis: A Single-Blind Randomised Controlled Trial. Pain Res Manag. 2022 Oct 21;2022:1319165. doi: 10.1155/2022/1319165. eCollection 2022.
- Background: PubMed 33074393Akaltun MS, Altindag O, Turan N, Gursoy S, Gur A. Efficacy of high intensity laser therapy in knee osteoarthritis: a double-blind controlled randomized study. Clin Rheumatol. 2021 May;40(5):1989-1995. doi: 10.1007/s10067-020-05469-7. Epub 2020 Oct 19.
- Background: PubMed 32831189Song HJ, Seo HJ, Kim D. Effectiveness of high-intensity laser therapy in the management of patients with knee osteoarthritis: A systematic review and meta-analysis of randomized controlled trials. J Back Musculoskelet Rehabil. 2020;33(6):875-884. doi: 10.3233/BMR-191738.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications arising from this study will be available upon reasonable request. Data that support the primary and secondary outcome analyses, including pain, functional status, and muscle strength measurements, may be shared after publication of the primary study results. Requests will be evaluated by the Principal Investigator and must include a scientifically sound research proposal. All shared data will be fully de-identified to protect participant confidentiality.
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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.
Ivan Patricio Silva-Satlov, Magister principal investigator
Universidad Metropolitana de Ciencias de la Educación
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 and Exercise in people with Osteoarthritic Knee Pain and Osteo Arthritis of the Knee, run by Universidad Metropolitana de Ciencias de la Educacion at 1 site in Chile.
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 3 inclusion and 5 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 5 Jun 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 Chile. 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?
Change From Baseline in Knee Extensor Muscle Strength After 4 Weeks of Treatment (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07630259, which also lists 4 linked publications.
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 5 Jun 2026.