Comparison of Three Treatments for Lower Extremity Apophysitis

NCT ID: NCT01826071

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2023-10-31

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.

Conditions

Osgood-Schlatter Syndrome (OSS); Sinding-Larson and Johansson Syndrome (SLJ); Sever's Disease; Apophysitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Symptomatic Treatment

acetaminophen, NSAID, ice and relative rest

Group Type: NO_INTERVENTION

No interventions assigned to this group

Static Stretch

Home exercise program with static stretching

Group Type: EXPERIMENTAL

Static Stretch

Intervention Type: OTHER

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

Active Elongation

Home exercise program with active elongation exercises

Group Type: EXPERIMENTAL

Active Elongation

Intervention Type: OTHER

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

Interventions

Static Stretch

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

Intervention Type: OTHER

Active Elongation

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Carl, MD

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca L Carl, MD

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

2013-15150

Identifier Type: -

Identifier Source: org_study_id