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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Feb 1, 2027 → Apr 30, 2027
Primary endpoint added 5 → 6 primary endpoints
See other at-risk trials from Medical University of Gdansk

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary endpoint(s) modified Show 6 more changesShow less
    • Primary completion pushed from Feb 1, 2027 to Apr 30, 2027
    • Enrollment increased: 30 → 36 participants
    • Study completion moved earlier from Feb 1, 2029 to May 31, 2027
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 8 of 8 entries
    • Study description expanded, about 213 words
  2. Minor Secondary endpoints: 10 to 8
    • Study description expanded, about 44 words
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 1, 2026 to Mar 1, 2026
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 samples for research measurements Participants will not know which treatment group they are in until the study ends.
Trial Details
NCT Number NCT07446517
Lead Sponsor Medical University of Gdansk
Conditions
(from sponsor)
Osgood-Schlatter Disease, Sever's Disease
Related terms Osteochondrosis
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov