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Comparison of Three Treatments for Lower Extremity Apophysitis

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ClinicalTrials.gov Identifier: NCT01826071
Recruitment Status : Unknown
Verified March 2013 by Rebecca Carl, MD, Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was:  Recruiting
First Posted : April 8, 2013
Last Update Posted : April 8, 2013
Sponsor:
Collaborator:
American Medical Society for Sports Medicine
Information provided by (Responsible Party):
Rebecca Carl, MD, Ann & Robert H Lurie Children's Hospital of Chicago

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.


Condition or disease Intervention/treatment Phase
Osgood-Schlatter Syndrome Sinding-Larsen and Johansson Syndrome Sever's Disease Apophysitis Other: Static Stretch Other: Active Elongation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Three Treatments for Lower Extremity Apophysitis
Study Start Date : October 2012
Estimated Primary Completion Date : November 2013

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



Primary Outcome Measures :
  1. Pain [ Time Frame: 8 weeks ]
    Likert Pain Scale


Secondary Outcome Measures :
  1. Missed time from sports/physical activities [ Time Frame: 8 weeks ]
    Missed time from sports/physical activities in days



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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826071


Locations
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United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Rebecca L Carl, MD    312-227-6524    rcarl@luriechildrens.org   
Principal Investigator: Rebecca L Carl, MD         
Sub-Investigator: Cynthia R LaBella, MD         
Sub-Investigator: Brian Hang, MD         
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
American Medical Society for Sports Medicine
Investigators
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Principal Investigator: Rebecca L Carl, MD Ann & Robert H Lurie Children's Hospital of Chicago

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Responsible Party: Rebecca Carl, MD, Assistant Professor of Pediatrics, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01826071     History of Changes
Other Study ID Numbers: 2013-15150
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: March 2013
Keywords provided by Rebecca Carl, MD, Ann & Robert H Lurie Children's Hospital of Chicago:
Osgood-Schlatter syndrome (OSS)
Sinding-Larsen and Johansson syndrome (SLJ)
Sever's disease
apophysitis
Additional relevant MeSH terms:
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Osteitis
Syndrome
Disease
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases