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

NCT07446517 · tracked via the Priya Life Science Poland tracker

Sponsor

Medical University of Gdansk

Phase

Not applicable

Started

2026-03-01

Last updated

2026-10-09

Condition(s) studied

Osgood-Schlatter DiseaseSever's Disease

Investigational drug(s) / intervention(s)

Photobiomodulation (Low-Level Laser Therapy)Sham Photobiomodulation (Sham Laser Treatment)

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.

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.

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 samples for research measurements

Participants will not know which treatment group they are in until the study ends.

Eligibility

Sex

ALL

Min age

10 Years

Max age

17 Years

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * Current pain episode started after an acute injury (for example, fall, collision, ankle sprain, or similar trauma) * Prior surgery on the lower limb * Known diagnosis of patellofemoral pain syndrome (pain around/behind the kneecap) * Known patellar instability (recurrent kneecap dislocations or giving way) * Known complex regional pain syndrome * History of lower-limb fracture * Ultrasound shows clinically important abnormalities in the assessed area that are not consistent with the target condition (for example, calcifications or other significant findings) * Known chronic or systemic disease that may affect the musculoskeletal system (for example, inflammatory joint disease or other clinically significant chronic conditions) * Received any of the following in the last 3 months: steroid injection, hydrodilatation, or laser therapy * Used non-steroidal anti-inflammatory drugs (NSAIDs) (for example, ibuprofen, naproxen) within the last 14 days, or currently uses them * Clinically important abnormal blood test results (complete blood count) that may affect safety or data validity * Parent/guardian or participant does not agree to participate, or withdraws consent/assent

Primary outcome measure(s)

Recruitment feasibility: proportion of eligible participants enrolled — From first screening contact through completion of enrollment.
Proportion enrolled among eligible candidates; threshold ≥80% within the recruitment window.
Retention feasibility: proportion completing post-intervention and follow-up assessments — Baseline to post-intervention (≈2 weeks) and baseline to ≈3 months after the end of laser sessions.
Proportion of randomized participants with complete assessments at baseline and post-intervention, and with 3-month follow-up data taken from LEAP-REHAB; threshold 20% attrition.
Adherence feasibility: proportion of intervention sessions completed — During the 2-week intervention period.
Percentage of planned sessions completed (10 total); threshold ≥8/10 sessions and ≥80% adherence.
Data completeness feasibility: proportion of complete datasets for key clinical outcomes — Baseline through approximately 3 months after the end of laser sessions.
Proportion of randomized participants with complete data for NPRS, PGIC, the applicable site-specific function measure (KOOS-Child or OxAFQ-C), treatment adherence, safety, and blinding-assessment fields. Target: at least 90% completeness of expected measurements.
Safety and tolerability: number and type of adverse events related to the intervention — During the 2-week intervention period.
Count and classification of adverse events temporally associated with treatment sessions.
Blinding credibility: participant allocation guesses — Immediately after the 2-week intervention
After the immediate post-intervention assessment, participants guess whether they received active treatment or sham treatment, or indicate that they do not know, and rate their confidence. The proportion of correct guesses and Bang's blinding index with 95% confidence intervals are summarized descriptively.

Trial sites (1)

Facility	City	Region	Status
Department of Immunobiology and Environment Microbiology, Debinki 7	Gdansk	Pomeranian	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07446517 on ClinicalTrials.gov ↗ ← All trials in Poland