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

NCT07446517 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-04

No results posted yet for this study

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.

Conditions

  • Osgood-Schlatter Disease
  • Sever's Disease

Interventions

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.

Sponsors & Collaborators

  • Medical University of Gdansk

    lead OTHER

Principal Investigators

  • Bartosz Wilczyński, PhD · Medical University of Gdansk

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-02-01
Completion
2029-02-01

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07446517 on ClinicalTrials.gov