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

NCT07446517 | Recruiting

• 3 other identifiers: KB/591/2025-202671-01428DEC-2025/09/X/NZ7/01758
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Osgood-Schlatter Disease; Sever's Disease

Keywords

Low-Level Laser Therapy; Photobiomodulation; Osgood-Schlatter Disease; Apophysitis; Traction Apophysitis; Heel Pain; Tibial Tubercle Pain

Outcome Measures

Primary Outcomes (5)

• Recruitment feasibility: proportion of eligible participants enrolled

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

  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.

  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.

  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.

  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.

  During the 2-week intervention period.

Secondary Outcomes (10)

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

  2 weeks

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

  3 months

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

  Baseline and 2 weeks

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

  Baseline and 3 months

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

  Baseline and 2 weeks

Other Outcomes (18)

• Change From Baseline in Ultrasound Features of the Symptomatic Apophysis at 2 Weeks

  Baseline and 2 weeks

• Change From Baseline in C-Reactive Protein at 2 Weeks

  Baseline and 2 weeks

• Change From Baseline in Interleukin-6 at 2 Weeks

  Baseline and 2 weeks.

Study Arms (2)

Active Photobiomodulation (Low-Level Laser Therapy)

EXPERIMENTAL

Participants will receive active photobiomodulation (low-level laser therapy) applied to the symptomatic apophyseal region (tibial tubercle for Osgood-Schlatter-type pain and/or calcaneal region for Sever-type pain) using standardized device settings and application procedures. Treatment will be delivered in a series of sessions over the intervention period. All participants will also receive the same standardized conservative-care guidance (e.g., education and exercise/activity advice) provided to both study arms.

Device: Photobiomodulation (Low-Level Laser Therapy)

Sham Comparator

SHAM COMPARATOR

Participants will receive sham (placebo) laser treatment using the same device appearance, positioning, contact, and session schedule as the active intervention, but without delivery of therapeutic light. The sham procedure is designed to maintain blinding. All participants will also receive the same standardized conservative-care guidance (e.g., education and exercise/activity advice) provided to both study arms.

Device: Sham Photobiomodulation (Sham Laser Treatment)

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.

Also known as: Low-Level Laser Therapy, Laser Photobiomodulation

Active Photobiomodulation (Low-Level Laser Therapy)

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.

Also known as: Placebo Laser Treatment, Inactive Laser Treatment

Sham Comparator

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Department of Immunobiology and Environment Microbiology, Debinki 7

Gdansk, Pomeranian, 80-210, Poland

RECRUITING

MeSH Terms

Conditions

Osteochondrosis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Bartosz Wilczyński, PhD

  Medical University of Gdansk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bartosz Wilczyński, PhD

CONTACT

+48 732 414 195; bartosz.wilczynski@gumed.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized to active photobiomodulation (low-level laser therapy) or sham treatment. The sham procedure uses an identical device and treatment routine but does not deliver therapeutic light. Participants and outcome assessors will be blinded to group assignment. Investigators responsible for study oversight and data analysis will remain blinded until the database is locked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: March 3, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)