NCT07446517

Low-Level Laser Therapy for Osgood-Schlatter or Sever Pain in Youth Athletes

Effect of Low-Level Laser Photobiomodulation on Pain, Function, Ultrasound Findings, and Biochemical Markers in Youth Athletes With Osgood-Schlatter Disease or Sever Disease: A Randomized, Double-Blind, Sham-Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Medical University of Gdansk · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if low-level laser therapy (also called photobiomodulation) works to treat knee or heel pain in physically active children and adolescents with Osgood-Schlatter disease or Sever disease. It will also learn about the safety of this treatment. The main questions it aims to answer are: 1. Does low-level laser therapy lower pain more than a sham (placebo) laser treatment? 2. Does low-level laser therapy improve daily and sport-related function more than a sham laser treatment? 3. What medical problems, if any, do participants have during the study? Researchers will compare active low-level laser therapy to a sham (placebo) laser treatment. The sham treatment looks and feels the same but does not deliver therapeutic light. This comparison will show whether the laser therapy works better than placebo. Participants will: * Complete screening and a baseline visit * Be randomly assigned to active laser therapy or sham laser therapy * Receive a series of treatment sessions over \[2 weeks\] * Answer short questionnaires about pain and function at baseline and follow-up visits * Have ultrasound imaging and/or provide blood or urine samples for research measurements Both participants and the study team who assess outcomes will not know which treatment group each participant is in until the study ends.

Detailed description

This pilot randomized, placebo-controlled, double-masked clinical trial evaluates the feasibility and preliminary clinical signal of laser photobiomodulation (low-level laser therapy; LLLT) in youth athletes (10-17 years) with symptomatic lower-extremity apophyseal pathology, primarily consistent with Osgood-Schlatter disease and/or calcaneal apophysitis (Sever disease) confirmed clinically and by ultrasound. Participants will be randomized 1:1 to active LLLT or sham LLLT. The intervention consists of 10 sessions over 2 weeks (5 sessions/week) delivered with a class 3B GaAlAs (Gallium-Aluminum-Arsenide) laser device using standardized parameters (near-infrared wavelength range; continuous mode; preset energy density; contact application over the symptomatic apophyseal region). Sham procedures are identical in appearance, session duration, and device operation but deliver 0 mW output. The primary objective is feasibility (recruitment, retention, adherence, data completeness, safety). Secondary objectives are estimate-only between-group differences in pain and function at post-intervention and follow-up. Mechanistic measures (biomarkers and ultrasound features) are exploratory and used to inform the design of a future full-scale trial.

Conditions

• Osgood-Schlatter Disease
• Sever's Disease

Interventions

Type	Name	Description
DEVICE	Photobiomodulation (Low-Level Laser Therapy)	Active photobiomodulation (low-level laser therapy) delivered using a laser device applied to the symptomatic apophyseal region (tibial tubercle for Osgood-Schlatter-type pain and/or calcaneal region for Sever-type pain). Sessions will be provided according to a standardized schedule and preset device parameters (wavelength/output/dose and application time) specified in the protocol.
DEVICE	Sham Photobiomodulation (Sham Laser Treatment)	Sham (placebo) photobiomodulation delivered with an identical device appearance and treatment routine (positioning, contact, and session duration) but without delivery of therapeutic light. The sham procedure is intended to maintain participant blinding and matches the active intervention schedule.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-02-01
• Completion: 2029-02-01
• First posted: 2026-03-03
• Last updated: 2026-03-17

Locations

1 site across 1 country: Poland