Healthy Tendon
Conditions
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.
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.
Interventions
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.
Sponsors
Centro Universitario La Salle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tendon Thickness | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Victorian Institute of Sport Assessment-Patella (VISA-P) Score | Baseline and 4 weeks | 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. |
Countries
Spain
Outcome results
None listed