NCT01826071

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

11 years

First QC Date

March 29, 2013

Last Update Submit

February 6, 2025

Conditions

Keywords

Osgood-Schlatter syndrome (OSS)Sinding-Larsen and Johansson syndrome (SLJ)Sever's diseaseapophysitisgrowthknee

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 INTERVENTION

acetaminophen, NSAID, ice and relative rest

Static Stretch

EXPERIMENTAL

Home exercise program with static stretching

Other: Static Stretch

Active Elongation

EXPERIMENTAL

Home exercise program with active elongation exercises

Other: Active Elongation

Interventions

Standing Gastrocnemius Stretch Standing Soleus Stretch Seated Gastrocnemius Stretch Seated Soleus Stretch Hamstring Stretch Quadriceps Stretch (Standing) Quadriceps Stretch (Side Lying)

Static Stretch

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

Active Elongation

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

Study Officials

  • Rebecca L Carl, MD

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

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

Locations