Osgood-Schlatter Disease, Sever's Disease
Conditions
Keywords
Low-Level Laser Therapy, Photobiomodulation, Osgood-Schlatter Disease, Apophysitis, Traction Apophysitis, Heel Pain, Tibial Tubercle Pain
Brief 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.
Detailed description
This pilot randomized, participant-blinded, sham-controlled trial evaluates the feasibility, safety, and preliminary clinical signals of low-level 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 are randomized 1:1 to active photobiomodulation or sham treatment and receive 10 sessions over 2 weeks 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. Ultrasound is repeated after the intervention as an exploratory mechanistic assessment. Blood samples are collected at baseline only and are not repeated after the intervention. After completion of the 2-week intervention and the immediate post-intervention assessment (T1), participants are offered the separately registered LEAP-REHAB exercise programme (NCT07521280; 12 weeks, started after the end of laser sessions), and most randomized participants entered it. No separate 3-month visit is performed. The 3-month outcomes are taken from the LEAP-REHAB visit closest to 3 months after the end of laser sessions (within 4 weeks), performed by physiotherapists who were not informed of the laser allocation. They therefore reflect the laser course followed by, or overlapping with, the exercise programme. Both study arms were eligible for the exercise programme on the same terms. The global rating of change in LEAP-REHAB refers to the start of the exercise programme, and a 3-month rating anchored to the pre-laser baseline is available only for participants in whom that item was collected. Participants who did not take part in LEAP-REHAB have missing 3-month data and are reported as lost to follow-up. Allocation was assigned by drawing sealed opaque envelopes, without replacement, from a prepared pool containing equal numbers of active and sham envelopes. Allocation was not stratified. The planned sample size was increased from 30 to 36 (18 per arm) to allow for attrition, and the recruitment window was extended to 31 December 2026 because the originally anticipated recruitment period was not met. These changes were made before any analysis of outcomes. Enrollment during the first recruitment phase was restricted to male participants. Whether female participants will be randomized in this trial will be specified before they are enrolled.
Interventions
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.
DEVICESham 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.
Sponsors
Medical University of Gdansk
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants and their parents/caregivers are masked to group allocation. The physiotherapist who delivers the intervention is necessarily unmasked, and the principal investigator has access to the allocation list. Post-intervention (T1) clinical assessments were performed by a physiotherapist who was aware of allocation. Questionnaires, including the global rating of change and the allocation-guess questionnaire, are completed by the participant and collected by the treating physiotherapist or a substitute. The biostatistician analyses coded group labels. The 3-month outcomes are taken from LEAP-REHAB visits performed by physiotherapists who were not informed of the allocation.
Intervention model description
Participants will be randomized in a 1:1 ratio to one of two parallel groups: (1) active photobiomodulation (low-level laser therapy) or (2) sham (placebo) laser treatment. Each participant will receive the assigned intervention for the full intervention period, with identical visit schedules and assessments in both groups.
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Rated as Responders on the Patient Global Impression of Change (PGIC) at 2 Weeks | 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". |
| Proportion of Participants Rated as Responders on the Patient Global Impression of Change (PGIC) at 3 Months | 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." |
| Change From Baseline in Pain Intensity as Measured by the Numeric Pain Rating Scale (NPRS) at 2 Weeks | Baseline and 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. |
| Change From Baseline in Pain Intensity as Measured by the Numeric Pain Rating Scale (NPRS) at 3 Months | Baseline and 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. |
| Change From Baseline in Knee Function as Measured by the KOOS-Child at 2 Weeks (Osgood-Schlatter Subgroup) | Baseline and 2 weeks | 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. |
| Change From Baseline in Knee Function as Measured by the KOOS-Child at 3 Months (Osgood-Schlatter Subgroup) | Baseline and 3 months | 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. |
| Change From Baseline in Foot/Ankle Function (OxAFQ-C) at Post-intervention (2 weeks), Sever Subgroup Only | Baseline and 2 weeks | OxAFQ-C domains 0-100 (higher=better). Metric: change from baseline to ≈2 weeks. Assessed only in Sever participants. |
| Change From Baseline in Foot/Ankle Function (OxAFQ-C) at Follow-up (3 months), Sever Subgroup Only | Baseline and 3 months | OxAFQ-C domains 0-100 (higher=better). Metric: change from baseline to 3 months. |
Countries
Poland
Contacts
CONTACTBartosz Wilczyński, PhD
PRINCIPAL_INVESTIGATORBartosz Wilczyński, PhD
Medical University of Gdansk
Outcome results
None listed