Effects of High-Intensity Laser Therapy on Tendon Tissue

NCT07817368 | Active Not Recruiting

• 1 other identifier: CSEULS-PI-007/2025
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Tendon

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and throughout the 4-week intervention period

Secondary Outcomes (1)

• Change in Victorian Institute of Sport Assessment-Patella (VISA-P) Score

  Baseline and 4 weeks

Study Arms (4)

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.

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.

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.

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.

Device: High intensity Laser Therapy (HILT)

Interventions

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.

High-Intensity Laser therapy (10W); High-Intensity Laser therapy (20W); High-Intensity Laser therapy (2W); High-Intensity Laser therapy (placebo)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Universitario La Salle: lead

Study Sites (1)

CSEU La Salle

Madrid, Madrid, 28023, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and participants were blinded to treatment allocation. Participants were randomly assigned to one of three active HILT groups or a placebo group. Group allocation was known only to the investigator responsible for administering the laser intervention. Ultrasound and Doppler assessments were performed by an investigator who was unaware of treatment allocation
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 14, 2026
• Study Start: March 1, 2024
• Primary Completion: September 15, 2026
• Study Completion: September 15, 2026
• Last Updated: September 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)