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Clinical Trials/NCT01826071
NCT01826071CompletedNot Applicable

Comparison of Three Treatments for Lower Extremity Apophysitis

Ann & Robert H Lurie Children's Hospital of Chicago1 site in 1 country129 target enrollmentStarted: October 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
129
Locations
1
Primary Endpoint
Change in pain rating of a 5 point Likert type pain scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
8 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Symptomatic Treatment

No Intervention

acetaminophen, NSAID, ice and relative rest

Static Stretch

Experimental

Home exercise program with static stretching

Intervention: Static Stretch (Other)

Active Elongation

Experimental

Home exercise program with active elongation exercises

Intervention: Active Elongation (Other)

Outcomes

Primary Outcomes

Change in pain rating of a 5 point Likert type pain scale

Time Frame: 8 weeks

The Likert-type pain scale is a self-reported pain scale asking participants to rate pain

Secondary Outcomes

  • Missed time from sports/physical activities(8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rebecca Carl, MD

Associate Professor of Pediatrics

Ann & Robert H Lurie Children's Hospital of Chicago

Study Sites (1)

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