Individualized Rehabilitation for Osgood-Schlatter or Sever Pain in Youth Athletes

NCT07521280 | Not Yet Recruiting

• 2 other identifiers: KB/591/2025-2026-REHAB71-01428
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Can this rehabilitation program be delivered with good attendance, good home-exercise adherence, and complete follow-up data?
2. 2.Do pain, function, and sports participation improve during the rehabilitation period?
3. 3.Which baseline clinical, functional, ultrasound, maturity, or biomarker features may help explain who responds better to rehabilitation?
4. 4.Attend baseline and follow-up physiotherapy assessments.
5. 5.Receive an individualized rehabilitation plan with education, pain and load monitoring, and home exercises.
6. 6.Complete home exercises and keep a short symptom and activity log.
7. 7.Attend in-person physiotherapy review visits during the rehabilitation period.
8. 8.Answer questionnaires about pain, function, perceived change, and sports participation during follow-up.

Conditions

Osgood-Schlatter Disease; Sever's Disease; Apophyseal Pain

Keywords

Osgood-Schlatter Disease; Sever's Disease; Knee Pain; Heel Pain; Return to Sport; Load Management; Apophyseal Pain; Youth Athletes; Exercise Therapy; Physical Therapy; Rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

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

  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.

  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.

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

Secondary Outcomes (6)

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

  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

  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

  Baseline and approximately 12 weeks

• Return-to-Sport Status at Follow-Up

  Approximately 12 weeks

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

  Approximately 12 weeks

Study Arms (1)

Individualized Load-Based Rehabilitation Pathway

EXPERIMENTAL

Participants receive a 12-week individualized rehabilitation pathway for current or previous lower-extremity apophyseal pain, including Osgood-Schlatter-related knee pain and Sever-related heel pain. The intervention 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, but 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. Participants may enter after completion of a separate photobiomodulation trial, by direct entry with active symptoms, or by direct entry with previous symptoms and a low-irritability or residual presentation. These entry routes are not treatment arms.

Behavioral: Individualized Load-Based Rehabilitation Pathway

Interventions

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.

Also known as: Activity-Ladder Rehabilitation, Symptom-Guided Rehabilitation Program, Load-Tolerance Rehabilitation Program

Individualized Load-Based Rehabilitation Pathway

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 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 and/or Sever-related heel pain, or has previous Osgood-Schlatter-related or Sever-related symptoms with a residual or low-irritability presentation relevant to rehabilitation
• Meets criteria for at least one pre-specified rehabilitation entry pathway:
• post-trial rehabilitation entry after completion of the separate photobiomodulation trial, or direct-entry rehabilitation with active apophyseal symptoms, or direct-entry rehabilitation with previous Osgood-Schlatter-related or Sever-related symptoms and a low-irritability or 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, loading, or sport participation
• pain is reproducible on clinical examination or the clinical 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, symptom/activity monitoring, and follow-up assessments.
• A parent or legal guardian provides written informed consent, and the participant provides assent when applicable.

You may not qualify if:

• 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
• Any medical or developmental condition that would prevent safe participation in exercise-based rehabilitation
• Current symptoms requiring urgent medical assessment or management outside the rehabilitation pathway
• 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

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Department of Immunobiology and Environment Microbiology

Gdansk, Debinki 7, 80-210, Poland

Location

MeSH Terms

Conditions

Osteochondrosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Bartosz Wilczyński

  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: NA
• Masking: NONE
• Masking Details: This is an open-label rehabilitation study. Participants, families, and treating physiotherapists are aware that rehabilitation is being delivered. Because the intervention includes education, exercise instruction, and activity modification, masking of participants and care providers is not feasible.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-group interventional rehabilitation study. All participants receive the same overall 12-week individualized rehabilitation pathway, including education, pain and load monitoring, activity modification, symptom-guided exercise progression, motor-control training, basic strength exercises, and gradual return to sport-related loading. The starting level, dose, progression, and temporary regression are adjusted according to symptoms, current activity level, movement quality, treatment tolerance, response after exercise, and clinical judgement. Participants may enter after the separate photobiomodulation trial, by direct entry with active apophyseal symptoms, or by direct entry with previous symptoms and a low-irritability/residual presentation. These entry routes are not treatment arms and will be used only for descriptive and exploratory subgroup analyses.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 9, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): April 5, 2027
• Study Completion (Estimated): April 5, 2029
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The study protocol will be made openly available through the Open Science Framework (OSF). De-identified individual participant data, the statistical analysis plan, and analytic code will be made available after publication of the primary study results and will remain available for at least 5 years after publication.
• Access Criteria: The study protocol will be openly accessible through OSF. De-identified individual participant data, the statistical analysis plan, and analytic code will be available to qualified researchers upon reasonable request and approval of a methodologically sound proposal. Data will be shared only for non-commercial research purposes and after signing a data use agreement.

Locations

PL (1)