Individualized Rehabilitation 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 a 12-week individualized rehabilitation program is feasible and helpful for children and adolescents with 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, whether the program can be delivered as planned, and whether pain, function, and sports participation improve during rehabilitation.

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? 3. Which baseline clinical, functional, ultrasound, maturity, or biomarker features may help explain who responds better to rehabilitation?

All participants will receive the same overall rehabilitation framework. The program includes education, pain and load monitoring, an activity-ladder approach, symptom-guided exercise progression, motor-control training, basic strength exercises, and gradual return to running, jumping, landing, and sport-specific activities. Exercises are individualized according to symptoms, current activity level, movement quality, treatment tolerance, and clinical judgement.

Participants will:

1. Attend baseline and follow-up physiotherapy assessments. 2. Receive an individualized rehabilitation plan with education, pain and load monitoring, and home exercises. 3. Complete home exercises and keep a short symptom and activity log. 4. Attend in-person physiotherapy review visits during the rehabilitation period. 5. Answer questionnaires about pain, function, perceived change, and sports participation during follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 10 to 17 years

Participates in organized sport and has at least 12 months of sport participation or training history

Has current lower-extremity apophyseal pain consistent with Osgood-Schlatter-related knee pain, Sever-related heel pain, and/or Sinding-Larsen-Johansson-related pain at the inferior pole of the patella, or has previous symptoms of these conditions with a residual or low-irritability presentation relevant to rehabilitation

pain is located at the tibial tubercle region, the inferior pole of the patella, and/or the calcaneal apophyseal/heel region

Disqualifiers

Current pain episode started after an acute traumatic injury that better explains the 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, safety, or interpretation of outcomes

Known serious musculoskeletal, neurological, rheumatological, inflammatory, autoimmune, metabolic, or other systemic disease that may affect safe participation or interpretation of outcomes

Trial design

Design model

Single group

Treatments tested in this trial

  • Individualized Load-Based Rehabilitation Pathway

    Behavioral

    This intervention is a 12-week individualized 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 includes education, pain and load monitoring, activity modification, symptom-guided exercise progression, motor-control training, basic strength exercises, and gradual return to sport-related loading. All participants receive the same overall rehabilitation framework. The starting level, exercise variants, dose, progression, and temporary regressions are adjusted according to symptoms, current activity level, movement quality, treatment tolerance, response after exercise, and clinical judgement. Progression is guided by pain during exercise, symptom response after the session and the next day, perceived exertion, and movement quality, rather than by fixed timelines alone.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Individualized Load-Based Rehabilitation PathwayExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Proportion of participants who complete the planned in-person physiotherapy review visits during the 12-week rehabilitation period. Successful completion will be defined as attendance at the minimum planned core visit set, including baseline rehabilitation entry and at least the planned follow-up review visits required by the protocol.

Time frame
From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)
2

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)
3

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. Required elements include pain and load monitoring, review of symptoms and activity exposure, exercise review, progression or regression decision, and home-program update.

Time frame
From rehabilitation entry through completion of the rehabilitation period (approximately 12 weeks)
4

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)

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

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