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Comparison of Three Treatments for Lower Extremity Apophysitis

Primary Purpose

Osgood-Schlatter Syndrome, Sinding-Larsen and Johansson Syndrome, Sever's Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Static Stretch
Active Elongation
Sponsored by
Ann & Robert H Lurie Children's Hospital of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osgood-Schlatter Syndrome focused on measuring Osgood-Schlatter syndrome (OSS), Sinding-Larsen and Johansson syndrome (SLJ), Sever's disease, apophysitis

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Symptomatic Treatment

Static Stretch

Active Elongation

Arm Description

Home exercise program with static stretching

Home exercise program with active elongation exercises

Outcomes

Primary Outcome Measures

Pain
Likert Pain Scale

Secondary Outcome Measures

Missed time from sports/physical activities
Missed time from sports/physical activities in days

Full Information

First Posted
March 29, 2013
Last Updated
April 5, 2013
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
American Medical Society for Sports Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01826071
Brief Title
Comparison of Three Treatments for Lower Extremity Apophysitis
Official Title
Comparison of Three Treatments for Lower Extremity Apophysitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
American Medical Society for Sports Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osgood-Schlatter Syndrome, Sinding-Larsen and Johansson Syndrome, Sever's Disease, Apophysitis
Keywords
Osgood-Schlatter syndrome (OSS), Sinding-Larsen and Johansson syndrome (SLJ), Sever's disease, apophysitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Symptomatic Treatment
Arm Type
No Intervention
Arm Title
Static Stretch
Arm Type
Experimental
Arm Description
Home exercise program with static stretching
Arm Title
Active Elongation
Arm Type
Experimental
Arm Description
Home exercise program with active elongation exercises
Intervention Type
Other
Intervention Name(s)
Static Stretch
Intervention Type
Other
Intervention Name(s)
Active Elongation
Primary Outcome Measure Information:
Title
Pain
Description
Likert Pain Scale
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Missed time from sports/physical activities
Description
Missed time from sports/physical activities in days
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca L Carl, MD
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca L Carl, MD
Phone
312-227-6524
Email
rcarl@luriechildrens.org
First Name & Middle Initial & Last Name & Degree
Rebecca L Carl, MD
First Name & Middle Initial & Last Name & Degree
Cynthia R LaBella, MD
First Name & Middle Initial & Last Name & Degree
Brian Hang, MD

12. IPD Sharing Statement

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Comparison of Three Treatments for Lower Extremity Apophysitis

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