Osgood-Schlatter Disease Clinical Trials

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Feasibility, Clinical Response, and Exploratory Predictors of an Individualized Load-Based Rehabilitation Pathway in Youth Athletes With Osgood-Schlatter Disease or Sever Disease: A Prospective Single-Arm Interventional Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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. 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
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Poland
Department of Immunobiology and Environment Microbiology
RECRUITING
Gdansk
Contact Information
Primary
Bartosz Wilczyński, PhD
bartosz.wilczynski@gumed.edu.pl
+48 732 414 195
Time Frame
Start Date: 2026-05-20
Estimated Completion Date: 2029-04-05
Participants
Target number of participants: 45
Treatments
Experimental: Individualized Load-Based Rehabilitation Pathway
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.
Related Therapeutic Areas
Sponsors
Leads: Medical University of Gdansk

This content was sourced from clinicaltrials.gov