Low-level laser treatment for knee or heel pain in young athletes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-masked, placebo-controlled pilot trial in youth athletes (10–17 years) with clinically and ultrasound-confirmed apophyseal pain consistent with Osgood‑Schlatter or Sever disease. Participants are randomized 1:1 to active low-level laser therapy (class 3B GaAlAs near-infrared device) or a sham device that looks and operates the same but delivers no output, receiving 10 sessions over two weeks. The primary aim is feasibility (recruitment, retention, adherence, data completeness, and safety), with secondary, estimate-only comparisons of pain and function after treatment and at follow-up. Exploratory mechanistic measures include ultrasound features and biomarkers to inform design of a future full-scale trial.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Immunobiology and Environment Microbiology, Debinki 7
  Gdansk, Pomeranian, Poland Recruiting

Study contacts

• Principal investigator: Bartosz Wilczyński, PhD — Medical University of Gdansk
• Study coordinator: Bartosz Wilczyński, PhD
• Email: bartosz.wilczynski@gumed.edu.pl
• Phone: +48 732 414 195

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.