Healthy TendonNCT07817368
Effects of High-Intensity Laser Therapy on Tendon Tissue
A study testing High intensity Laser Therapy (HILT) in people with Healthy Tendon, run by Centro Universitario La Salle at 1 site in Spain.
Trial summary
This randomized controlled trial evaluates the effects of high-intensity laser therapy (HILT) on tendon structure and vascularization in healthy university students. Participants are randomly assigned to receive HILT at different power settings or a placebo intervention. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Tendon
- What is being tested?
- High intensity Laser Therapy (HILT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2024to 15 Sep 2026
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- University students aged 18 to 30 years. Male or female participants. Body mass index (BMI) between 18.0 and 29.9 kg/m². Intact thermal sensitivity and ability to perceive and communicate pain. Willingness to participate in the study. Provision of written informed consent.
Who cannot join
- Metabolic or cardiovascular diseases. Active infections. History of fractures affecting the study region. Tumors. Pregnancy. Use of medications that may affect blood circulation, pain perception, or mental status.
- Skin alterations in the treatment area, including ulcers, hematomas, or psoriasis.
- Previous surgery or scars in the patellar tendon region. Knee prosthesis or previous knee arthroplasty. Acute inflammation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High-Intensity Laser Therapy on Tendon Tissue in Healthy Participants: A Randomized Clinical Trial
This randomized controlled trial evaluates the effects of high-intensity laser therapy (HILT) on tendon structure and vascularization in healthy university students. Participants are randomly assigned to receive HILT at different power settings or a placebo intervention. The intervention is administered twice a week for four weeks. Tendon thickness and vascularization are assessed using ultrasound and Doppler imaging before and during the intervention period. The study aims to determine whether different HILT power settings produce changes in tendon structure or vascularization in healthy individuals.
Read the detailed description
This study investigates the effects of high-intensity laser therapy (HILT) on the patellar tendon in healthy young adults. HILT is a photobiomodulation intervention that may produce biological and microcirculatory effects in musculoskeletal tissues; however, its effects on healthy tendon tissue remain insufficiently understood.
A randomized, placebo-controlled design is used to compare three HILT power settings (2 W, 10 W, and 20 W) with a placebo intervention. Participants are healthy university students aged 18 to 30 years. The intervention is administered twice weekly for four weeks. Ultrasound imaging is used to assess tendon morphology and Doppler imaging is used to evaluate vascularization. Functional status is also assessed using the Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire.
The study is designed to determine whether repeated HILT application at different power settings induces measurable structural, vascular, or functional changes in healthy patellar tendon tissue.
- Conditions
- Healthy Tendon
- Being tested
- High intensity Laser Therapy (HILT)
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) is applied to the tendon using a BTL-6000 High Intensity Laser device. Participants assigned to the active intervention receive one of three power settings: 2 W for 6 minutes 59 seconds, 10 W for 1 minute 24 seconds, or 20 W for 42 seconds. Treatment is administered twice weekly for 4 weeks, for a total of 8 sessions. Ultrasound assessments of the tendon are performed during the study to evaluate structural and vascular changes.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Laser therapy (2W) | Experimental | Participants in this arm receive high-intensity laser therapy (HILT) applied to the tendon at a power of 2 W. The intervention is administered for 6 minutes and 59 seconds per session, twice weekly for 4 weeks, for a total of 8 treatment sessions. Receives: Device: High intensity Laser Therapy (HILT) |
| High-Intensity Laser therapy (10W) | Experimental | Participants in this arm receive high-intensity laser therapy (HILT) applied to the tendon at a power of 10 W. The intervention is administered for 1 minutes and 24 seconds per session, twice weekly for 4 weeks, for a total of 8 treatment sessions. Receives: Device: High intensity Laser Therapy (HILT) |
| High-Intensity Laser therapy (20W) | Experimental | Participants in this arm receive high-intensity laser therapy (HILT) applied to the tendon at a power of 20 W. The intervention is administered for 42 seconds per session, twice weekly for 4 weeks, for a total of 8 treatment sessions. Receives: Device: High intensity Laser Therapy (HILT) |
| High-Intensity Laser therapy (placebo) | Placebo comparator | Participants in this arm undergo the same procedures as the active HILT groups, but no therapeutic laser energy is delivered. The laser device is applied with zero power and no laser emission. The placebo intervention is administered twice weekly for 4 weeks, for a total of 8 sessions. Receives: Device: High intensity Laser Therapy (HILT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tendon Thickness
Tendon thickness will be assessed by musculoskeletal ultrasound using a linear transducer. Measurements will be recorded in millimeters (mm) and compared across the intervention period to assess changes associated with HILT at different power settings and placebo.
Measured: Baseline and throughout the 4-week intervention period
Change in Tendon Vascularization
Tendon vascularization will be assessed along the tendon using Doppler ultrasound. The presence of vascularization will be evaluated during the study to determine whether repeated HILT application at different power settings produces changes in tendon vascularity compared with placebo.
Measured: Baseline and throughout the 4-week intervention period
Secondary outcomes (1)
Change in Victorian Institute of Sport Assessment-Patella (VISA-P) Score
Patellar tendon-related symptoms and function will be assessed using the Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire. The VISA-P is scored from 0 to 100 points, with higher scores indicating better function and fewer patellar tendon-related symptoms. The questionnaire will be administered at baseline and at the end of the 4-week intervention period.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Mar 2024
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy TendonStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario La Salle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Vicente Leon Hernandez, Centro Universitario La Salle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817368
- Sponsor's protocol ID
- CSEULS-PI-007/2025
- Status last verified
- Aug 2026
- First submitted
- 3 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) are not planned to be shared because no data-sharing plan was established in the original study protocol or informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Intensity Laser Therapy on Tendon Tissue in Healthy Participants: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07817368
- Acronym / sponsor ID
- CSEULS-PI-007/2025
- Conditions
- Healthy Tendon
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Centro Universitario La SalleUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 14 Sep 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 controlled trial evaluates the effects of high-intensity laser therapy (HILT) on tendon structure and vascularization in healthy university students. Participants are randomly assigned to receive HILT at different power settings or a placebo intervention. The intervention is administered twice a week for four weeks. Tendon thickness and vascularization are assessed using ultrasound and Doppler imaging before and during the intervention period. The study aims to determine whether different HILT power settings produce changes in tendon structure or vascularization in healthy individuals.
Detailed description
This study investigates the effects of high-intensity laser therapy (HILT) on the patellar tendon in healthy young adults. HILT is a photobiomodulation intervention that may produce biological and microcirculatory effects in musculoskeletal tissues; however, its effects on healthy tendon tissue remain insufficiently understood.
A randomized, placebo-controlled design is used to compare three HILT power settings (2 W, 10 W, and 20 W) with a placebo intervention. Participants are healthy university students aged 18 to 30 years. The intervention is administered twice weekly for four weeks. Ultrasound imaging is used to assess tendon morphology and Doppler imaging is used to evaluate vascularization. Functional status is also assessed using the Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire.
The study is designed to determine whether repeated HILT application at different power settings induces measurable structural, vascular, or functional changes in healthy patellar tendon tissue.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Laser therapy (2W) | Experimental | Device: High intensity Laser Therapy (HILT)Participants in this arm receive high-intensity laser therapy (HILT) applied to the tendon at a power of 2 W. The intervention is administered for 6 minutes and 59 seconds per session, twice weekly for 4 weeks, for a total of 8 treatment sessions. |
| High-Intensity Laser therapy (10W) | Experimental | Device: High intensity Laser Therapy (HILT)Participants in this arm receive high-intensity laser therapy (HILT) applied to the tendon at a power of 10 W. The intervention is administered for 1 minutes and 24 seconds per session, twice weekly for 4 weeks, for a total of 8 treatment sessions. |
| High-Intensity Laser therapy (20W) | Experimental | Device: High intensity Laser Therapy (HILT)Participants in this arm receive high-intensity laser therapy (HILT) applied to the tendon at a power of 20 W. The intervention is administered for 42 seconds per session, twice weekly for 4 weeks, for a total of 8 treatment sessions. |
| High-Intensity Laser therapy (placebo) | Placebo comparator | Device: High intensity Laser Therapy (HILT)Participants in this arm undergo the same procedures as the active HILT groups, but no therapeutic laser energy is delivered. The laser device is applied with zero power and no laser emission. The placebo intervention is administered twice weekly for 4 weeks, for a total of 8 sessions. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- University students aged 18 to 30 years. Male or female participants. Body mass index (BMI) between 18.0 and 29.9 kg/m². Intact thermal sensitivity and ability to perceive and communicate pain. Willingness to participate in the study. Provision of written informed consent.
Key exclusion criteria (3 listed)
- Metabolic or cardiovascular diseases. Active infections. History of fractures affecting the study region. Tumors. Pregnancy. Use of medications that may affect blood circulation, pain perception, or mental status.
- Skin alterations in the treatment area, including ulcers, hematomas, or psoriasis.
- Previous surgery or scars in the patellar tendon region. Knee prosthesis or previous knee arthroplasty. Acute inflammation.
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) is applied to the tendon using a BTL-6000 High Intensity Laser device. Participants assigned to the active intervention receive one of three power settings: 2 W for 6 minutes 59 seconds, 10 W for 1 minute 24 seconds, or 20 W for 42 seconds. Treatment is administered twice weekly for 4 weeks, for a total of 8 sessions. Ultrasound assessments of the tendon are performed during the study to evaluate structural and vascular changes. | Device | High-Intensity Laser therapy (10W), High-Intensity Laser therapy (20W), High-Intensity Laser therapy (2W), High-Intensity Laser therapy (placebo) |
Primary outcome
Change in Tendon Thickness
Time frame: Baseline and throughout the 4-week intervention period
Tendon thickness will be assessed by musculoskeletal ultrasound using a linear transducer. Measurements will be recorded in millimeters (mm) and compared across the intervention period to assess changes associated with HILT at different power settings and placebo.
Change in Tendon Vascularization
Time frame: Baseline and throughout the 4-week intervention period
Tendon vascularization will be assessed along the tendon using Doppler ultrasound. The presence of vascularization will be evaluated during the study to determine whether repeated HILT application at different power settings produces changes in tendon vascularity compared with placebo.
1 secondary outcome
Change in Victorian Institute of Sport Assessment-Patella (VISA-P) Score
Time frame: Baseline and 4 weeks
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 14 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) are not planned to be shared because no data-sharing plan was established in the original study protocol or informed consent.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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) in people with Healthy Tendon, run by Centro Universitario La Salle at 1 site in Spain.
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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 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 Spain. 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?
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?
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 in Tendon Thickness (time frame: Baseline and throughout the 4-week intervention period). 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 14 Sep 2026.