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NCT07521280

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

Sponsor: Medical University of Gdansk

View on ClinicalTrials.gov

Summary

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

Official title: Feasibility and Preliminary Clinical Evaluation of a State-Based Load Tolerance and Rule-Based Individualized Rehabilitation Pathway in Youth Athletes With Current or Previous Lower-Extremity Apophyseal Pain

Key Details

Gender

All

Age Range

10 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-05

Completion Date

2029-04-05

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Osgood-Schlatter Disease Sever's Disease Apophyseal Pain

Interventions

BEHAVIORAL

State-Based Rehabilitation Pathway

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.

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

Locations (1)

Department of Immunobiology and Environment Microbiology

Gdansk, Debinki 7, Poland