Low-Level Laser Therapy for Osgood-Schlatter or Sever Pain in Youth Athletes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorMedical University of Gdansk
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Photobiomodulation (Low-Level Laser Therapy)
DeviceActive 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)
DeviceSham (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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Active Photobiomodulation (Low-Level Laser Therapy)Experimental treatment 1 intervention
Group B: Sham ComparatorSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.2
Retention feasibility: proportion completing post-intervention and follow-up assessments
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.
Time frame
Baseline to post-intervention (≈2 weeks) and baseline to ≈3 months after the end of laser sessions.3
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.4
Data completeness feasibility: proportion of complete datasets for key clinical outcomes
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.
Time frame
Baseline through approximately 3 months after the end of laser sessions.Secondary outcomes
1
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 weeks2
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 months3
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 weeks4
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 monthsOther outcomes
1
Change From Baseline in Ultrasound Features of the Symptomatic Apophysis at 2 Weeks
Musculoskeletal ultrasound of the index symptomatic apophyseal site using a standardized acquisition protocol (high-frequency linear probe; fixed patient position). Predefined features will be graded on ordinal scales and summed into a prespecified composite "ultrasound severity score" (higher = greater abnormality). Features include: (1) apophyseal fragmentation/irregularity, (2) tendon insertion thickening, (3) hypoechogenicity, (4) bursal fluid/soft-tissue swelling. Metric: change in composite score from baseline to 2 weeks.
Time frame
Baseline and 2 weeks2
Treatment Expectancy and Credibility (TEC-C / TEC-P) at Baseline (Pre-intervention)
Treatment expectancy and credibility will be assessed in the child and parent/caregiver using pediatric versions of the Treatment Expectancy and Credibility measure (TEC-C and TEC-P). The child and caregiver complete the questionnaires independently (without influence on each other's responses). Scores are derived per instrument instructions (higher scores indicate greater expectancy/credibility).
Time frame
Pre-intervention (baseline), prior to the first treatment session and prior to functional testing.Sponsors and contacts
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Source ClinicalTrials.gov