[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627275":3},{"organization":4,"outcomesModule":7,"designInfo":119,"detailedDescription":132,"studyPopulation":124,"armGroups":133,"interventions":146,"overallOfficials":162,"centralContacts":166,"locations":171,"responsibleParty":190,"collaborators":124,"id":193,"slug":124,"hasResults":194,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":124,"eligibilityCriteria":198,"healthyVolunteers":194,"sex":199,"minAge":200,"maxAge":201,"enrollmentInfo":202,"targetDuration":124,"studyType":205,"phases":206,"briefSummary":208,"conditions":209,"keywords":212,"overallStatus":174,"whyStopped":124,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},{"fullName":5,"class":6},"Medical University of Gdansk","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":63},[9,13,17,21,25],{"measure":10,"description":11,"timeFrame":12},"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.",{"measure":14,"description":15,"timeFrame":16},"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).",{"measure":18,"description":19,"timeFrame":20},"Adherence feasibility: proportion of intervention sessions completed","Percentage of planned sessions completed (10 total); threshold ≥8\u002F10 sessions and ≥80% adherence.","During the 2-week intervention period.",{"measure":22,"description":23,"timeFrame":24},"Data completeness feasibility: proportion of complete datasets for key clinical outcomes","Proportion of participants with complete NPRS\u002FPGIC\u002FPODCI; threshold ≥90% complete.","Baseline to follow-up (≈3 months).",{"measure":26,"description":27,"timeFrame":20},"Safety and tolerability: number and type of adverse events related to the intervention","Count and classification of adverse events temporally associated with treatment sessions.",[29,33,37,41,45,48,51,54,57,60],{"measure":30,"description":31,"timeFrame":32},"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\".","2 weeks",{"measure":34,"description":35,"timeFrame":36},"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.\"","3 months",{"measure":38,"description":39,"timeFrame":40},"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.","Baseline and 2 weeks",{"measure":42,"description":43,"timeFrame":44},"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.","Baseline and 3 months",{"measure":46,"description":47,"timeFrame":40},"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\u002Fwell-being. The metric is change from baseline to 2 weeks",{"measure":49,"description":50,"timeFrame":44},"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\u002Fwell-being. The metric is change from baseline to 3 months.",{"measure":52,"description":53,"timeFrame":40},"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\u002Fbetter function). The metric is change from baseline to 2 weeks, assessed in the Osgood-Schlatter subgroup only.",{"measure":55,"description":56,"timeFrame":44},"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.",{"measure":58,"description":59,"timeFrame":40},"Change From Baseline in Foot\u002FAnkle 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.",{"measure":61,"description":62,"timeFrame":44},"Change From Baseline in Foot\u002FAnkle 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.",[64,67,70,74,77,80,83,86,90,93,96,99,102,105,108,111,114,117],{"measure":65,"description":66,"timeFrame":40},"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\u002Firregularity, (2) tendon insertion thickening, (3) hypoechogenicity, (4) bursal fluid\u002Fsoft-tissue swelling. Metric: change in composite score from baseline to 2 weeks.",{"measure":68,"description":69,"timeFrame":40},"Change From Baseline in C-Reactive Protein at 2 Weeks","Serum concentration of C-reactive protein (CRP), measured using enzyme-linked immunosorbent assay (ELISA) per protocol. Metric: change from baseline to 2 weeks. Unit of measure: per ELISA kit manufacturer instructions (e.g., mg\u002FL); values will be converted to a single standard unit for CRP prior to analysis.",{"measure":71,"description":72,"timeFrame":73},"Change From Baseline in Interleukin-6 at 2 Weeks","Serum concentration of interleukin-6 (IL-6), measured using enzyme-linked immunosorbent assay (ELISA) per protocol. Metric: change from baseline to 2 weeks. Unit of measure: per ELISA kit manufacturer instructions (e.g., pg\u002FmL); values will be converted to a single standard unit for IL-6 prior to analysis.","Baseline and 2 weeks.",{"measure":75,"description":76,"timeFrame":73},"Change From Baseline in Tumor Necrosis Factor-Alpha at 2 Weeks","Serum concentration of tumor necrosis factor-alpha (TNF-α), measured using enzyme-linked immunosorbent assay (ELISA) per protocol. Metric: change from baseline to 2 weeks. Unit of measure: per ELISA kit manufacturer instructions (e.g., pg\u002FmL); values will be converted to a single standard unit for TNF-α prior to analysis.",{"measure":78,"description":79,"timeFrame":40},"Change From Baseline in C-Terminal Cross-Linked Telopeptide of Type II Collagen at 2 Weeks","Serum concentration of C-terminal cross-linked telopeptide of type II collagen (CTX-II), measured using enzyme-linked immunosorbent assay (ELISA) per protocol. Metric: change from baseline to 2 weeks. Unit of measure: per ELISA kit manufacturer instructions (e.g., pg\u002FmL or ng\u002FmL); values will be converted to a single standard unit for CTX-II prior to analysis.",{"measure":81,"description":82,"timeFrame":73},"Change From Baseline in Type II Collagen Cleavage Neoepitope at 2 Weeks","Serum concentration of type II collagen cleavage neoepitope (C2C), measured using enzyme-linked immunosorbent assay (ELISA) per protocol. Metric: change from baseline to 2 weeks. Unit of measure: per ELISA kit manufacturer instructions (e.g., pg\u002FmL or ng\u002FmL); values will be converted to a single standard unit for C2C prior to analysis.",{"measure":84,"description":85,"timeFrame":73},"Change From Baseline in C-Propeptide of Type II Procollagen at 2 Weeks","Serum concentration of C-propeptide of type II procollagen (CPII), measured using enzyme-linked immunosorbent assay (ELISA) per protocol. Metric: change from baseline to 2 weeks. Unit of measure: per ELISA kit manufacturer instructions (e.g., pg\u002FmL or ng\u002FmL); values will be converted to a single standard unit for CPII prior to analysis.",{"measure":87,"description":88,"timeFrame":89},"Treatment Expectancy and Credibility (TEC-C \u002F TEC-P) at Baseline (Pre-intervention)","Treatment expectancy and credibility will be assessed in the child and parent\u002Fcaregiver 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\u002Fcredibility).","Pre-intervention (baseline), prior to the first treatment session and prior to functional testing.",{"measure":91,"description":92,"timeFrame":73},"Change From Baseline in Cartilage Oligomeric Matrix Protein at 2 Weeks","Serum concentration of cartilage oligomeric matrix protein (COMP), measured using enzyme-linked immunosorbent assay (ELISA) per protocol. Metric: change from baseline to 2 weeks. Unit of measure: per ELISA kit manufacturer instructions (e.g., ng\u002FmL); values will be converted to a single standard unit for COMP prior to analysis.",{"measure":94,"description":95,"timeFrame":40},"Change From Baseline in Procollagen Type I N-Terminal Propeptide at 2 Weeks","Serum concentration of procollagen type I N-terminal propeptide (PINP), measured using enzyme-linked immunosorbent assay (ELISA) per protocol. Metric: change from baseline to 2 weeks. Unit of measure: per ELISA kit manufacturer instructions (e.g., ng\u002FmL); values will be converted to a single standard unit for PINP prior to analysis.",{"measure":97,"description":98,"timeFrame":73},"Change From Baseline in Beta C-Terminal Telopeptide of Type I Collagen at 2 Weeks","Serum concentration of beta C-terminal telopeptide of type I collagen (β-CTX), measured using enzyme-linked immunosorbent assay (ELISA) per protocol. Metric: change from baseline to 2 weeks. Unit of measure: per ELISA kit manufacturer instructions (e.g., pg\u002FmL or ng\u002FmL); values will be converted to a single standard unit for β-CTX prior to analysis.",{"measure":100,"description":101,"timeFrame":40},"Change From Baseline in Tartrate-Resistant Acid Phosphatase 5b at 2 Weeks","Serum concentration or activity of tartrate-resistant acid phosphatase 5b (TRAP-5b), measured using enzyme-linked immunosorbent assay (ELISA) per protocol. Metric: change from baseline to 2 weeks. Unit of measure: per ELISA kit manufacturer instructions (e.g., U\u002FL or ng\u002FmL); values will be converted to a single standard unit for TRAP-5b prior to analysis.",{"measure":103,"description":104,"timeFrame":73},"Change From Baseline in Osteocalcin at 2 Weeks","Serum concentration of osteocalcin, measured using enzyme-linked immunosorbent assay (ELISA) per protocol. Metric: change from baseline to 2 weeks. Unit of measure: per ELISA kit manufacturer instructions (e.g., ng\u002FmL); values will be converted to a single standard unit for osteocalcin prior to analysis.",{"measure":106,"description":107,"timeFrame":73},"Change From Baseline in Bone-Specific Alkaline Phosphatase at 2 Weeks","Serum bone-specific alkaline phosphatase (BAP), measured per protocol (assay name per project documentation; if \"Ostase\u002FOstease\" is the assay, write it exactly as used by the lab). Metric: change from baseline to 2 weeks.",{"measure":109,"description":110,"timeFrame":73},"Change From Baseline in Total Serum Calcium at 2 Weeks","Total serum calcium concentration, measured using laboratory assay per protocol. Metric: change from baseline to 2 weeks. Unit of measure: per laboratory assay (e.g., mmol\u002FL or mg\u002FdL); values will be converted to a single standard unit for total serum calcium prior to analysis if required.",{"measure":112,"description":113,"timeFrame":73},"Change From Baseline in 25-Hydroxyvitamin D at 2 Weeks","Serum 25-hydroxyvitamin D (25(OH)D), measured using laboratory assay per protocol. Metric: change from baseline to 2 weeks. Unit of measure: ng\u002FmL (or nmol\u002FL) per laboratory assay; values will be converted to a single standard unit for 25(OH)D prior to analysis if required.",{"measure":115,"description":116,"timeFrame":73},"Change From Baseline in 1,25-Dihydroxyvitamin D at 2 Weeks","Serum 1,25-dihydroxyvitamin D (1,25(OH)₂D), measured using laboratory assay per protocol. Metric: change from baseline to 2 weeks. Unit of measure: pg\u002FmL (or pmol\u002FL) per laboratory assay; values will be converted to a single standard unit for 1,25(OH)₂D prior to analysis if required.",{"measure":106,"description":118,"timeFrame":73},"Serum concentration or activity of bone-specific alkaline phosphatase (BAP), measured using enzyme-linked immunosorbent assay (ELISA) per protocol (assay name per project documentation, if applicable). Metric: change from baseline to 2 weeks. Unit of measure: per ELISA kit manufacturer instructions (e.g., U\u002FL or µg\u002FL); values will be converted to a single standard unit for BAP prior to analysis.",{"allocation":120,"interventionModel":121,"interventionModelDescription":122,"primaryPurpose":123,"observationalModel":124,"timePerspective":124,"maskingInfo":125},"RANDOMIZED","PARALLEL","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.","TREATMENT",null,{"masking":126,"maskingDescription":127,"whoMasked":128},"TRIPLE","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.",[129,130,131],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","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\u002For calcaneal apophysitis (Sever disease) confirmed clinically and by ultrasound.\n\nParticipants will be randomized 1:1 to active LLLT or sham LLLT. The intervention consists of 10 sessions over 2 weeks (5 sessions\u002Fweek) 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.\n\nThe 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.",[134,140],{"label":135,"type":136,"description":137,"interventionNames":138},"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\u002For 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\u002Factivity advice) provided to both study arms.",[139],"Device: Photobiomodulation (Low-Level Laser Therapy)",{"label":141,"type":142,"description":143,"interventionNames":144},"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\u002Factivity advice) provided to both study arms.",[145],"Device: Sham Photobiomodulation (Sham Laser Treatment)",[147,155],{"type":148,"name":149,"description":150,"armGroupLabels":151,"otherNames":152},"DEVICE","Photobiomodulation (Low-Level Laser Therapy)","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\u002For calcaneal region for Sever-type pain). Sessions will be provided according to a standardized schedule and preset device parameters (wavelength\u002Foutput\u002Fdose and application time) specified in the protocol.",[135],[153,154],"Low-Level Laser Therapy","Laser Photobiomodulation",{"type":148,"name":156,"description":157,"armGroupLabels":158,"otherNames":159},"Sham 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.",[141],[160,161],"Placebo Laser Treatment","Inactive Laser Treatment",[163],{"name":164,"affiliation":5,"role":165},"Bartosz Wilczyński, PhD","PRINCIPAL_INVESTIGATOR",[167],{"name":164,"role":168,"phone":169,"phoneExt":124,"email":170},"CONTACT","+48 732 414 195","bartosz.wilczynski@gumed.edu.pl",[172],{"facility":173,"status":174,"city":175,"state":176,"zip":177,"country":178,"countryCode":179,"cosmosGeoPoint":180,"geoPoint":185,"contacts":186},"Department of Immunobiology and Environment Microbiology, Debinki 7","RECRUITING","Gdansk","Pomeranian","80-210","Poland","PL",{"type":181,"coordinates":182},"Point",[183,184],18.64912,54.35227,{"lat":184,"lon":183},[187],{"name":164,"role":168,"phone":188,"phoneExt":189,"email":170},"58 349 17 66","+48",{"type":165,"investigatorFullName":191,"investigatorTitle":192,"investigatorAffiliation":5,"oldNameTitle":124,"oldOrganization":124},"Bartosz Wilczyński","Principal Investigator","100627275",false,"NCT07446517","Low-Level Laser Therapy for Osgood-Schlatter or Sever Pain in Youth Athletes","Effect of Low-Level Laser Photobiomodulation on Pain, Function, Ultrasound Findings, and Biochemical Markers in Youth Athletes With Osgood-Schlatter Disease or Sever Disease: A Randomized, Double-Blind, Sham-Controlled Trial","Inclusion Criteria:\n\n* Aged 10 to 17 years\n* Participates in organized sport with at least 12 months of training history\n* Has knee pain at the tibial tubercle (Osgood-Schlatter-type pain) and\u002For heel pain at the back of the heel (Sever-type pain)\n* Pain is worse with activity and reproduced by pressing on the painful area\n* 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)\n* Symptoms have been present for at least 2 weeks\n* For heel pain consistent with Sever disease, the heel squeeze test is positive\n* Ultrasound shows findings consistent with an apophyseal injury at the painful site\n* 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)\n* A parent\u002Fguardian provides written informed consent\n* The participant provides assent (agreement) to take part\n\nExclusion Criteria:\n\n* Current pain episode started after an acute injury (for example, fall, collision, ankle sprain, or similar trauma)\n* Prior surgery on the lower limb\n* Known diagnosis of patellofemoral pain syndrome (pain around\u002Fbehind the kneecap)\n* Known patellar instability (recurrent kneecap dislocations or giving way)\n* Known complex regional pain syndrome\n* History of lower-limb fracture\n* Ultrasound shows clinically important abnormalities in the assessed area that are not consistent with the target condition (for example, calcifications or other significant findings)\n* Known chronic or systemic disease that may affect the musculoskeletal system (for example, inflammatory joint disease or other clinically significant chronic conditions)\n* Received any of the following in the last 3 months: steroid injection, hydrodilatation, or laser therapy\n* Used non-steroidal anti-inflammatory drugs (NSAIDs) (for example, ibuprofen, naproxen) within the last 14 days, or currently uses them\n* Clinically important abnormal blood test results (complete blood count) that may affect safety or data validity\n* Parent\u002Fguardian or participant does not agree to participate, or withdraws consent\u002Fassent","ALL","10 Years","17 Years",{"count":203,"type":204},30,"ESTIMATED","INTERVENTIONAL",[207],"NA","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:\n\n1. Does low-level laser therapy lower pain more than a sham (placebo) laser treatment?\n2. Does low-level laser therapy improve daily and sport-related function more than a sham laser treatment?\n3. What medical problems, if any, do participants have during the study?\n\nResearchers 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.\n\nParticipants will:\n\n* Complete screening and a baseline visit\n* Be randomly assigned to active laser therapy or sham laser therapy\n* Receive a series of treatment sessions over \\[2 weeks\\]\n* Answer short questionnaires about pain and function at baseline and follow-up visits\n* Have ultrasound imaging and\u002For provide blood or urine samples for research measurements\n\nBoth participants and the study team who assess outcomes will not know which treatment group each participant is in until the study ends.",[210,211],"Osgood-Schlatter Disease","Sever's Disease",[153,213,210,214,215,216,217],"Photobiomodulation","Apophysitis","Traction Apophysitis","Heel Pain","Tibial Tubercle Pain","2026-03-14",{"date":220,"type":221},"2026-03-17","ACTUAL",{"date":223,"type":221},"2026-03-01",{"date":225,"type":204},"2029-02-01",{"name":5,"class":6},1]