Comparison of Three Treatments for Lower Extremity Apophysitis

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.

Study Overview

• Status: Unknown
• Conditions: Osgood-Schlatter Syndrome; Sinding-Larsen and Johansson Syndrome; Sever's Disease; Apophysitis
• Intervention / Treatment: Other: Static Stretch; Other: Active Elongation

Detailed Description

Osgood-Schlatter syndrome (OSS), Sinding-Larsen and Johansson syndrome (SLJ), or Sever's disease are three types of apophysitis, or secondary growth center irritation, that frequently affect children and teens. Although these conditions are common, there is very little data from high quality studies to support a particular treatment method in affected patients. The purpose of this study is to compare three different treatments for these types of apophysitis. The investigators plan to compare two types of home exercise program (HEP), one involving active elongation exercises and one utilizing static stretching, with symptomatic treatment consisting of icing, over-the-counter medications and relative rest. The investigators hypothesize that the active elongation HEP will result in improvement in pain and earlier return to athletic activities when compared to the static stretching HEP and symptomatic care. This pilot study will recruit subjects at the Ann & Robert H. Lurie Children's Hospital outpatient sports medicine and orthopaedic clinics with any of the following types of lower extremity apophysitis: OSS, SLJ or Sever's disease. Subjects will complete a baseline evaluation and questionnaire and will be randomized into one of the three treatment groups. At 2, 4, 6, and 8 weeks, subjects from all groups will use a secure website to complete an online survey to complete questions regarding current pain level, compliance with their home exercise program, if applicable, use of other forms of treatment or pain management (e.g. splinting, icing, rest from activities) and current activity level. The investigators will compare results from each group to determine which treatment(s) resulted in the largest improvements in pain scores and the highest rates of participation in sports and recreational activities.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Contact: Rebecca L Carl, MD; Phone Number: 312-227-6524; Email: rcarl@luriechildrens.org
      • Principal Investigator: Rebecca L Carl, MD
      • Sub-Investigator: Cynthia R LaBella, MD
      • Sub-Investigator: Brian Hang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosis of OSS, SLJ, or Sever's disease
• must have regular access to the Internet

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Symptomatic Treatment
Experimental: Static Stretch; Home exercise program with static stretching	Other: Static Stretch
Experimental: Active Elongation; Home exercise program with active elongation exercises	Other: Active Elongation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Likert Pain Scale	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Missed time from sports/physical activities	Missed time from sports/physical activities in days	8 weeks

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborators: American Medical Society for Sports Medicine
• Investigators: Principal Investigator: Rebecca L Carl, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): November 1, 2013
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: March 29, 2013
• First Submitted That Met QC Criteria: April 5, 2013
• First Posted (Estimate): April 8, 2013

Study Record Updates

• Last Update Posted (Estimate): April 8, 2013
• Last Update Submitted That Met QC Criteria: April 5, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Osgood-Schlatter syndrome (OSS); Sinding-Larsen and Johansson syndrome (SLJ); Sever's disease; apophysitis
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Musculoskeletal Diseases; Bone Diseases; Syndrome; Osteitis
• Other Study ID Numbers: 2013-15150

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No