Osgood-Schlatter DiseaseNCT07446517
Low-Level Laser Therapy for Osgood-Schlatter or Sever Pain in Youth Athletes
A study testing Photobiomodulation (Low-Level Laser Therapy) in people with Osgood-Schlatter Disease and Sever's Disease, run by Medical University of Gdansk at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Osgood-Schlatter Disease, Sever's Disease
- What is being tested?
- Photobiomodulation (Low-Level Laser Therapy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Immunobiology and Environment Microbiology, Debinki 7
Gdansk, Pomeranian, 80-210
Bartosz Wilczyński, PhD, 58 349 17 66 ext. +48, bartosz.wilczynski@gumed.edu.pl
About this study
Official title: Effect of Low-Level Laser Photobiomodulation on Pain, Function, and Ultrasound Findings in Youth Athletes With Osgood-Schlatter Disease or Sever Disease: A Randomized, Participant-Blinded, Sham-Controlled Pilot 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:
- Does low-level laser therapy lower pain more than a sham (placebo) laser treatment?
- Does low-level laser therapy improve daily and sport-related function more than a sham laser treatment?
- What medical problems, if any, do participants have during the study?
Read more
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.
Read the 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.
- Conditions
- Osgood-Schlatter Disease, Sever's Disease
- Being tested
- Photobiomodulation (Low-Level Laser Therapy), Sham Photobiomodulation (Sham Laser Treatment)
- Keywords
- Low-Level Laser Therapy, Photobiomodulation, Osgood-Schlatter Disease, Apophysitis, Traction Apophysitis, Heel Pain, Tibial Tubercle Pain
- Medical subject headings
- Osteochondrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation (Low-Level Laser Therapy)Device
Also called Low-Level Laser Therapy, Laser Photobiomodulation
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
Also called Placebo Laser Treatment, Inactive 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Photobiomodulation (Sham Laser Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility: proportion of eligible participants enrolled
Proportion enrolled among eligible candidates; threshold ≥80% within the recruitment window.
Measured: From first screening contact through completion of enrollment.
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.
Measured: Baseline to post-intervention (≈2 weeks) and baseline to ≈3 months after the end of laser sessions.
Adherence feasibility: proportion of intervention sessions completed
Percentage of planned sessions completed (10 total); threshold ≥8/10 sessions and ≥80% adherence.
Measured: During the 2-week intervention period.
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.
Measured: Baseline through approximately 3 months after the end of laser sessions.
Safety and tolerability: number and type of adverse events related to the intervention
Count and classification of adverse events temporally associated with treatment sessions.
Measured: During the 2-week intervention period.
Blinding credibility: participant allocation guesses
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.
Measured: Immediately after the 2-week intervention
Secondary outcomes (8)
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".
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Mar 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osgood-Schlatter DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bartosz Wilczyński, Medical University of Gdansk
- Investigators
- Bartosz Wilczyński, PhD, Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446517
- Sponsor's protocol ID
- KB/591/2025-2026
- Other IDs
- 71-01428, DEC-2025/09/X/NZ7/01758
- Status last verified
- Oct 2026
- First submitted
- 1 Feb 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in publications from this trial, along with a data dictionary, will be made available to qualified researchers. Data will include baseline characteristics, group allocation (coded), outcome measures, and adverse events. Data will be shared after publication of the primary results and will remain available for at least 5 years. Access will be provided upon reasonable request and approval of a methodologically sound proposal, with a signed data use agreement, and only for non-commercial research purposes. Supporting documents (protocol and statistical analysis plan) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Level Laser Photobiomodulation on Pain, Function, and Ultrasound Findings in Youth Athletes With Osgood-Schlatter Disease or Sever Disease: A Randomized, Participant-Blinded, Sham-Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07446517
- Acronym / sponsor ID
- KB/591/2025-2026
- Conditions
- Osgood-Schlatter Disease, Sever's Disease
- Keywords
- Low-Level Laser Therapy, Photobiomodulation, Osgood-Schlatter Disease, Apophysitis, Traction Apophysitis, Heel Pain, Tibial Tubercle Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does low-level laser therapy lower pain more than a sham (placebo) laser treatment?
- Does low-level laser therapy improve daily and sport-related function more than a sham laser treatment?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Photobiomodulation (Low-Level Laser Therapy) | Experimental | Device: Photobiomodulation (Low-Level Laser Therapy)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. |
| Sham Comparator | Sham comparator | Device: Sham Photobiomodulation (Sham Laser Treatment)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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation (Low-Level Laser Therapy)Also: Low-Level Laser Therapy, Laser PhotobiomodulationActive 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. | Device | Active Photobiomodulation (Low-Level Laser Therapy) |
| Sham Photobiomodulation (Sham Laser Treatment)Also: Placebo Laser Treatment, Inactive Laser TreatmentSham (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. | Device | Sham Comparator |
Primary outcome
Recruitment feasibility: proportion of eligible participants enrolled
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: During the 2-week intervention period.
Count and classification of adverse events temporally associated with treatment sessions.
Blinding credibility: participant allocation guesses
Time frame: 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.
8 secondary outcomes
Proportion of Participants Rated as Responders on the Patient Global Impression of Change (PGIC) at 2 Weeks
Time frame: 2 weeks
Proportion of Participants Rated as Responders on the Patient Global Impression of Change (PGIC) at 3 Months
Time frame: 3 months
Change From Baseline in Pain Intensity as Measured by the Numeric Pain Rating Scale (NPRS) at 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
Time frame: Baseline and 3 months
Change From Baseline in Knee Function as Measured by the KOOS-Child at 2 Weeks (Osgood-Schlatter Subgroup)
Time frame: Baseline and 2 weeks
Change From Baseline in Knee Function as Measured by the KOOS-Child at 3 Months (Osgood-Schlatter Subgroup)
Time frame: Baseline and 3 months
Change From Baseline in Foot/Ankle Function (OxAFQ-C) at Post-intervention (2 weeks), Sever Subgroup Only
Time frame: Baseline and 2 weeks
Change From Baseline in Foot/Ankle Function (OxAFQ-C) at Follow-up (3 months), Sever Subgroup Only
Time frame: Baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in publications from this trial, along with a data dictionary, will be made available to qualified researchers. Data will include baseline characteristics, group allocation (coded), outcome measures, and adverse events. Data will be shared after publication of the primary results and will remain available for at least 5 years. Access will be provided upon reasonable request and approval of a methodologically sound proposal, with a signed data use agreement, and only for non-commercial research purposes. Supporting documents (protocol and statistical analysis plan) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bartosz Wilczyński, PhD principal investigator
Medical University of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation (Low-Level Laser Therapy) in people with Osgood-Schlatter Disease and Sever's Disease, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bartosz Wilczyński, PhD (+48 732 414 195, bartosz.wilczynski@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility: proportion of eligible participants enrolled (time frame: From first screening contact through completion of enrollment.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.