State-Based Rehabilitation for Youth Athletes With Osgood-Schlatter or Sever-Related Apophyseal Pain

N/ANot Yet RecruitingNCT07521280

Medical University of Gdansk45 enrolled

Overview

The goal of this clinical trial is to learn if a state-based rehabilitation program is feasible and helpful for children and adolescents with current or past lower-extremity apophyseal pain, including Osgood-Schlatter-related knee pain and Sever-related heel pain. It will also learn about how well participants follow the program and whether the program can be delivered as planned. The main questions it aims to answer are: 1. Can this rehabilitation program be delivered with good attendance, good home-exercise adherence, and complete follow-up data? 2. Do pain, function, and sports participation improve during the rehabilitation period? All participants will receive the rehabilitation pathway. The program is adjusted to each participant's clinical presentation, pain irritability, activity limits, and main physical deficits. Participants will: * Attend baseline and follow-up physiotherapy assessments * Receive a rehabilitation plan that includes education, pain and load monitoring, and individualized exercises * Complete home exercises and keep a short symptom and activity log * Attend in-person physiotherapy sessions during the rehabilitation period * Answer questionnaires about pain, function, and sports participation during follow-up

This study evaluates a structured rehabilitation pathway for youth athletes with current or previous lower-extremity apophyseal pain, including Osgood-Schlatter-related knee pain and Sever-related heel pain. The rehabilitation pathway combines a state-based early load-management framework with a rule-based individualized exercise program and education for safe return to sport. The rehabilitation pathway is built around the Load Tolerance and Participation (LTP) Module. This module is used to classify each participant's current clinical state before rehabilitation progression. Classification is based on symptom irritability, participation restriction, clinical complexity, and recent load history. The purpose of this classification is to guide early decisions about activity modification, pain monitoring, exercise starting level, and progression or temporary regression of loading. All participants in this study receive the same overall rehabilitation framework. However, the content is individualized using predefined decision rules rather than clinician preference alone. Each participant receives: (1) a mandatory core module focused on pain/load tolerance, education, and activity modification; (2) one main deficit-targeted exercise module, selected according to baseline clinical findings; and (3) an optional additional module only when a second deficit is clearly present and clinically relevant. Deficit-targeted modules may address range of motion/flexibility, strength, or motor control. This study includes three pre-specified rehabilitation entry pathways. The first pathway includes participants who enter rehabilitation after completing the separate 2-week sham-controlled photobiomodulation trial (NCT07446517). The second pathway includes participants with active apophyseal pain who are not enrolled in that trial and enter rehabilitation directly after baseline assessment. The third pathway includes participants with a history of Osgood-Schlatter-related or Sever-related symptoms, or those with low-irritability/residual presentations, who enter rehabilitation directly in a lower-intensity or simplified pathway. These pathways are defined at study entry and will be used for pre-specified exploratory subgroup analyses. They are not intended to support causal comparisons of treatment effectiveness between groups. The rehabilitation phase includes in-person physiotherapy visits and a home exercise program. During follow-up, participants and families are instructed in pain monitoring, symptom-guided activity modification, weekly tracking of symptoms and sport exposure, and safe stepwise return to sport. Rehabilitation progression is guided by predefined pain-monitoring rules and trend monitoring across time, rather than by fixed timelines alone. This rehabilitation study is methodologically linked to the separately registered pilot sham-controlled photobiomodulation trial in youth athletes with apophyseal pain. Participants who complete that trial may enter this rehabilitation study through the post-trial pathway. However, the present study is focused on the rehabilitation pathway itself and is registered separately because the rehabilitation intervention, timing of entry, and clinical questions differ from those of the photobiomodulation trial.

Interventions

State-Based Rehabilitation PathwayBEHAVIORAL

This intervention is a structured rehabilitation program for youth athletes with current or previous lower-extremity apophyseal pain, including Osgood-Schlatter-related knee pain and Sever-related heel pain. The program combines education, pain and load monitoring, activity modification, and a rule-based individualized exercise program. Rehabilitation is guided by a state-based clinical framework, including symptom irritability, participation restriction, recent load history, maturation context, and clinical complexity. All participants receive the same overall rehabilitation pathway, including a core pain/load-tolerance module, and may also receive one main deficit-targeted exercise module, with an optional additional module when clinically indicated. Deficit-targeted modules may address range of motion/flexibility, strength, or dynamic control and balance. Progression and temporary regression are determined by pre-defined clinical decision rules rather than fixed timelines.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 10 to 17 years * Participates in organized sport and has at least 12 months of sport participation or training history * Has current or previous lower-extremity apophyseal pain consistent with Osgood-Schlatter-related knee pain and/or Sever-related heel pain * Meets criteria for at least one pre-specified rehabilitation entry pathway: * post-RCT rehabilitation entry after completion of the separate photobiomodulation trial, or * direct-entry rehabilitation with active symptoms, or * direct-entry rehabilitation with a history of Osgood-Schlatter-related or Sever-related symptoms and a low-irritability/residual presentation * For participants entering with active symptoms: * pain is located at the tibial tubercle region and/or the calcaneal apophyseal/heel region * pain is aggravated by activity or sport participation * pain is reproducible on clinical examination or history is consistent with the target condition * Participant and parent/caregiver are willing to take part in the rehabilitation program, including in-person visits, home exercises, and follow-up assessments * A parent or legal guardian provides written informed consent Exclusion Criteria: * Current pain episode started after an acute traumatic injury that better explains symptoms * Clinical presentation suggests a condition other than the target rehabilitation condition, including a major alternative knee or heel diagnosis requiring different management * Lower-limb surgery that would substantially affect rehabilitation planning or interpretation * Known serious musculoskeletal, neurological, rheumatological, inflammatory, autoimmune, or other systemic disease that may affect safe participation or interpretation of outcomes * Any medical or developmental condition that would prevent safe participation in exercise-based rehabilitation * Inability to understand study instructions or complete study procedures with parent/caregiver support * Parent/caregiver or participant does not agree to participate or withdraws consent/assent

Outcomes

Primary Outcomes

Feasibility of Rehabilitation Delivery: Proportion of Participants Completing the Planned In-Person Rehabilitation Sessions

Proportion of participants who complete the planned in-person physiotherapy sessions within the rehabilitation period. Completion will be defined according to the individualized rehabilitation schedule, with successful completion operationalized as attendance at the minimum planned core session set.

Time frame: From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)

Home Exercise Adherence During the Rehabilitation Period

Proportion of participants achieving the pre-specified home-exercise adherence target, defined as completing home exercises during at least 70% of study weeks.

Time frame: From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)

Intervention Fidelity: Proportion of Rehabilitation Visits Delivered According to Protocol

Proportion of in-person rehabilitation visits in which the required protocol elements were delivered and documented, including LTP-based review, pain/load monitoring, exercise progression decision, and home-program update.

Time frame: From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)

Retention: Proportion of Participants Completing Follow-Up Assessment

Proportion of enrolled participants who complete the planned follow-up assessment at the end of the rehabilitation period.

Time frame: From rehabilitation entry to end-of-study follow-up (approximately 12 weeks)

Safety: Number and Type of Adverse Events During Rehabilitation

Count and classification of adverse events temporally associated with the rehabilitation program, including symptom flare requiring modification, new musculoskeletal injury, or other clinically relevant problems during study participation.

Time frame: From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)

Secondary Outcomes

Change From Baseline in Worst Pain During the Last 7 Days as Measured by the Numeric Pain Rating Scale (NPRS)

NPRS ranges from 0 to 10, where 0 = no pain and 10 = worst pain imaginable. The main metric will be change in worst pain in the last 7 days from baseline to follow-up.

Time frame: Baseline and approximately 12 weeks

Change From Baseline in Knee Function as Measured by the Knee Injury and Osteoarthritis Outcome Score for Children (KOOS-Child) in the Osgood-Schlatter Subgroup

The Knee Injury and Osteoarthritis Outcome Score for Children (KOOS-Child) is a child-reported knee-specific questionnaire. Subscale scores are transformed to a 0 to 100 scale, where higher scores indicate better knee status, fewer symptoms, and better function. The primary metric will be change from baseline to approximately 12 weeks in the overall KOOS-Child score in the Osgood-Schlatter subgroup.

Time frame: Baseline and approximately 12 weeks

Change From Baseline in Foot/Ankle Function as Measured by the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) in the Sever Subgroup

The Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) is a child-reported measure of foot and ankle function. Domain scores are transformed to a 0 to 100 scale, where higher scores indicate better foot and ankle function and lower symptom impact. The metric is change from baseline to approximately 12 weeks in the overall OxAFQ-C score in the Sever subgroup only.

Time frame: Baseline and approximately 12 weeks

Return-to-Sport Status at Follow-Up

Return-to-sport status will be classified using pre-specified participation categories describing the participant's current level of sport involvement, ranging from restricted participation to full return to sport without planned limitations. Status will be recorded as an ordinal category at follow-up to describe sport participation during and after rehabilitation.

Time frame: Approximately 12 weeks

Proportion of Participants Reporting Meaningful Improvement on the Patient Global Impression of Change (PGIC) at Approximately 12 Weeks

PGIC is a 7-point scale of overall perceived change, ranging from very much improved to very much worse. Meaningful improvement is defined a priori as a rating of "much improved" or "very much improved." This outcome will be reported as the proportion of participants meeting that threshold at approximately 12 weeks.

State-Based Rehabilitation for Youth Athletes With Osgood-Schlatter or Sever-Related Apophyseal Pain

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts