Osgood-Schlatter Disease Clinical Trials

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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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: f
View:

• Aged 10 to 17 years

• Participates in organized sport with at least 12 months of training history

• Has knee pain at the tibial tubercle (Osgood-Schlatter-type pain) and/or heel pain at the back of the heel (Sever-type pain)

• Pain is worse with activity and reproduced by pressing on the painful area

• Pain intensity is 3 out of 10 or higher on the Numeric Pain Rating Scale (NPRS) during the clinical visit and in the last week (0 = no pain, 10 = worst pain imaginable)

• Symptoms have been present for at least 2 weeks

• For heel pain consistent with Sever disease, the heel squeeze test is positive

• Ultrasound shows findings consistent with an apophyseal injury at the painful site

• Has no signs of acute illness or infection on the assessment day and during the previous 14 days (for example, fever or flu-like symptoms)

• A parent/guardian provides written informed consent

• The participant provides assent (agreement) to take part

Locations
Other Locations
Poland
Department of Immunobiology and Environment Microbiology, Debinki 7
RECRUITING
Gdansk
Contact Information
Primary
Bartosz Wilczyński, PhD
bartosz.wilczynski@gumed.edu.pl
+48 732 414 195
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2029-02-01
Participants
Target number of participants: 30
Treatments
Experimental: Active Photobiomodulation (Low-Level Laser Therapy)
Participants will receive active photobiomodulation (low-level laser therapy) applied to the symptomatic apophyseal region (tibial tubercle for Osgood-Schlatter-type pain and/or calcaneal region for Sever-type pain) using standardized device settings and application procedures. Treatment will be delivered in a series of sessions over the intervention period. All participants will also receive the same standardized conservative-care guidance (e.g., education and exercise/activity advice) provided to both study arms.
Sham_comparator: Sham Comparator
Participants will receive sham (placebo) laser treatment using the same device appearance, positioning, contact, and session schedule as the active intervention, but without delivery of therapeutic light. The sham procedure is designed to maintain blinding. All participants will also receive the same standardized conservative-care guidance (e.g., education and exercise/activity advice) provided to both study arms.
Related Therapeutic Areas
Sponsors
Leads: Medical University of Gdansk

This content was sourced from clinicaltrials.gov

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