Low-level laser treatment for knee or heel pain in young athletes
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
NA · Medical University of Gdansk · NCT07446517
This trial will test whether low-level laser therapy helps reduce knee or heel pain and improve function in active children and teens (ages 10–17) with Osgood‑Schlatter or Sever disease compared with a placebo procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | Medical University of Gdansk (other) |
| Locations | 1 site (Gdansk, Pomeranian) |
| Trial ID | NCT07446517 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are 10–17 year-old athletes with activity-worse knee or heel pain that is clinically and ultrasound-confirmed as Osgood‑Schlatter or Sever disease, reporting at least 3/10 pain and symptoms lasting two weeks or more.
Not a fit: Children with other causes of knee or heel pain, recent acute illness, pain below 3/10, symptoms shorter than two weeks, or outside the 10–17 age range may be unlikely to benefit.
Why it matters
Potential benefit: If successful, this could provide a noninvasive, low-risk option to reduce pain and help young athletes return to sport sooner.
How similar studies have performed: Photobiomodulation has produced mixed but sometimes positive results for adult musculoskeletal pain, while randomized evidence in youth apophyseal conditions is limited and this application is largely preliminary.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gdansk, Pomeranian
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osgood-Schlatter Disease, Sever's Disease, Low-Level Laser Therapy, Photobiomodulation, Apophysitis, Traction Apophysitis, Heel Pain, Tibial Tubercle Pain