Comparison of Three Treatments for Lower Extremity Apophysitis
1 other identifier
interventional
129
1 country
1
Brief Summary
The purpose of this study is to compare three different treatments for these types of lower extremity apophysitis- Osgood-Schlatter syndrome (OSS), Sinding-Larsen and Johansson syndrome (SLJ), or Sever's disease. The investigators hypothesize that adolescents who perform a home exercise program (HEP) consisting of active elongation exercises will have decreased pain and earlier return to sports and activities as compared to those who perform a HEP that consists of static stretching exercises or those who use symptomatic treatment with ice, acetaminophen or NSAIDs and activity modification.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 29, 2013
CompletedFirst Posted
Study publicly available on registry
April 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedFebruary 10, 2025
February 1, 2025
11 years
March 29, 2013
February 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in pain rating of a 5 point Likert type pain scale
The Likert-type pain scale is a self-reported pain scale asking participants to rate pain
8 weeks
Secondary Outcomes (1)
Missed time from sports/physical activities
8 weeks
Study Arms (3)
Symptomatic Treatment
NO INTERVENTIONacetaminophen, NSAID, ice and relative rest
Static Stretch
EXPERIMENTALHome exercise program with static stretching
Active Elongation
EXPERIMENTALHome exercise program with active elongation exercises
Interventions
Standing Gastrocnemius Stretch Standing Soleus Stretch Seated Gastrocnemius Stretch Seated Soleus Stretch Hamstring Stretch Quadriceps Stretch (Standing) Quadriceps Stretch (Side Lying)
Mini Squat- Double Leg Mini Squat- Single Leg Prone Hip Extension with Knee Flexed 3 Position Straight Leg Raises Quadriceps Myofascial Release Heel Raises (Eccentric Strengthening) Single Leg and Double Leg Gastrocnemius Myofascial Release Calcaneal Glides
Eligibility Criteria
You may qualify if:
- diagnosis of OSS, SLJ, or Sever's disease
- must have regular access to the Internet
You may not qualify if:
- history of prior treatment for OSS, SLJ, or Sever's disease
- history of previous injury to the affected joint requiring more than 1 week off of sports or activities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca L Carl, MD
Ann & Robert H Lurie Children's Hospital of Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
March 29, 2013
First Posted
April 8, 2013
Study Start
October 1, 2012
Primary Completion
October 1, 2023
Study Completion
October 1, 2023
Last Updated
February 10, 2025
Record last verified: 2025-02