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

Medical University of Gdansk30 enrolled

Overview

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.

This pilot randomized, placebo-controlled, double-masked clinical trial evaluates the feasibility and preliminary clinical signal of laser photobiomodulation (low-level laser therapy; LLLT) in youth athletes (10-17 years) with symptomatic lower-extremity apophyseal pathology, primarily consistent with Osgood-Schlatter disease and/or calcaneal apophysitis (Sever disease) confirmed clinically and by ultrasound. Participants will be randomized 1:1 to active LLLT or sham LLLT. The intervention consists of 10 sessions over 2 weeks (5 sessions/week) delivered with a class 3B GaAlAs (Gallium-Aluminum-Arsenide) laser device using standardized parameters (near-infrared wavelength range; continuous mode; preset energy density; contact application over the symptomatic apophyseal region). Sham procedures are identical in appearance, session duration, and device operation but deliver 0 mW output. The primary objective is feasibility (recruitment, retention, adherence, data completeness, safety). Secondary objectives are estimate-only between-group differences in pain and function at post-intervention and follow-up. Mechanistic measures (biomarkers and ultrasound features) are exploratory and used to inform the design of a future full-scale trial.

Study Type

INTERVENTIONAL

Interventions

Photobiomodulation (Low-Level Laser Therapy)DEVICE

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)DEVICE

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.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Recruitment feasibility: proportion of eligible participants enrolled

Proportion enrolled among eligible candidates; threshold ≥80% within the recruitment window.

Time frame: From first screening contact through completion of enrollment.

Retention feasibility: proportion completing post-intervention and follow-up assessments

Proportion with complete assessments at baseline and post-intervention; threshold ≤20% attrition.

Time frame: Baseline to post-intervention (≈2 weeks) and baseline to follow-up (≈3 months).

Adherence feasibility: proportion of intervention sessions completed

Percentage of planned sessions completed (10 total); threshold ≥8/10 sessions and ≥80% adherence.

Time frame: During the 2-week intervention period.

Data completeness feasibility: proportion of complete datasets for key clinical outcomes

Proportion of participants with complete NPRS/PGIC/PODCI; threshold ≥90% complete.

Time frame: Baseline to follow-up (≈3 months).

Safety and tolerability: number and type of adverse events related to the intervention

Count and classification of adverse events temporally associated with treatment sessions.

Time frame: During the 2-week intervention period.

Secondary Outcomes

Proportion of Participants Rated as Responders on the Patient Global Impression of Change (PGIC) at 2 Weeks

PGIC is a 7-point global change scale from "very much improved" to "very much worse." A responder is defined as "much improved" or "very much improved".

Time frame: 2 weeks

Proportion of Participants Rated as Responders on the Patient Global Impression of Change (PGIC) at 3 Months

PGIC is a 7-point global change scale from "very much improved" to "very much worse." A responder is defined as "much improved" or "very much improved."

Time frame: 3 months

Change From Baseline in Pain Intensity as Measured by the Numeric Pain Rating Scale (NPRS) at 2 Weeks

NPRS ranges from 0 to 10, where 0 = no pain and 10 = worst pain imaginable. Pain intensity refers to worst pain in the last 7 days. The metric is change from baseline to 2 weeks.

Time frame: Baseline and 2 weeks

Change From Baseline in Pain Intensity as Measured by the Numeric Pain Rating Scale (NPRS) at 3 Months

NPRS ranges from 0 to 10, where 0 = no pain and 10 = worst pain imaginable. Pain intensity refers to worst pain in the last 7 days. The metric is change from baseline to 3 months.

Time frame: Baseline and 3 months

Change From Baseline in Pediatric Function as Measured by the Pediatric Outcomes Data Collection Instrument (PODCI) at 2 Weeks

PODCI domain scores are standardized from 0 to 100, where higher scores indicate better function/well-being. The metric is change from baseline to 2 weeks

Time frame: Baseline and 2 weeks

Change From Baseline in Pediatric Function as Measured by the Pediatric Outcomes Data Collection Instrument (PODCI) at 3 Months

PODCI domain scores are standardized from 0 to 100, where higher scores indicate better function/well-being. The metric is change from baseline to 3 months.

Time frame: Baseline and 3 months

Change From Baseline in Knee Function as Measured by the KOOS-Child at 2 Weeks (Osgood-Schlatter Subgroup)

KOOS-Child subscale scores are transformed to a 0 to 100 scale, where higher scores indicate better knee status (fewer symptoms/better function). The metric is change from baseline to 2 weeks, assessed in the Osgood-Schlatter subgroup only.

Time frame: Baseline and 2 weeks

Change From Baseline in Knee Function as Measured by the KOOS-Child at 3 Months (Osgood-Schlatter Subgroup)

KOOS-Child subscale scores are transformed to a 0 to 100 scale, where higher scores indicate better knee status. The metric is change from baseline to 3 months, assessed in the Osgood-Schlatter subgroup only.

Time frame: Baseline and 3 months

Change From Baseline in Foot/Ankle Function (OxAFQ-C) at Post-intervention (2 weeks), Sever Subgroup Only

OxAFQ-C domains 0-100 (higher=better). Metric: change from baseline to ≈2 weeks. Assessed only in Sever participants.

Time frame: Baseline and 2 weeks

Change From Baseline in Foot/Ankle Function (OxAFQ-C) at Follow-up (3 months), Sever Subgroup Only

OxAFQ-C domains 0-100 (higher=better). Metric: change from baseline to 3 months.

Time frame: Baseline and 3 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts