Actively Recruiting

Phase Not Applicable
Age: 10Years - 17Years
All Genders
NCT07446517

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

Led by Medical University of Gdansk · Updated on 2026-03-17

30

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 10Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 during the clinical visit and in the last week
  • 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
  • A parent/guardian provides written informed consent
  • The participant provides assent to take part
Not Eligible

You will not qualify if you...

  • Current pain episode started after an acute injury such as a fall, collision, or ankle sprain
  • Prior surgery on the lower limb
  • Known diagnosis of patellofemoral pain syndrome
  • Known patellar instability or recurrent kneecap dislocations
  • Known complex regional pain syndrome
  • History of lower-limb fracture
  • Ultrasound shows significant abnormalities not related to the target condition
  • Known chronic or systemic diseases affecting the musculoskeletal system
  • Received steroid injection, hydrodilatation, or laser therapy in the last 3 months
  • Used NSAIDs within the last 14 days or currently uses them
  • Clinically important abnormal blood test results
  • Parent/guardian or participant does not agree to participate or withdraws consent

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Department of Immunobiology and Environment Microbiology, Debinki 7

Gdansk, Pomeranian, Poland, 80-210

Actively Recruiting

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Research Team

B

Bartosz Wilczyński, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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