Effectiveness of Dextrose Injection for Osgood-Schlatter Disease

February 22, 2011 updated by: Universidad Nacional de Rosario

Phase 2 Study of Dextrose Injection for Sport-Limiting Osgood Schlatter Disease in Adolescents.

Objective: To examine the potential of dextrose injection versus lidocaine injection versus supervised usual care to change pain/function/activity levels in adolescent athletes with Osgood-Schlatter Disease (OSD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients and methods: Girls ages 9-15 years old and boys ages 10-17 years old will be assigned to either therapist-supervised usual care, or to double-blind injection of 1% lidocaine solution with or without 12.5% dextrose. Injections will be administered monthly for three months. All subjects will then be offered dextrose injections monthly as needed. Change in the Nirschl Pain Phase Scale (NPPS) will serve as the primary outcome measure.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Hospital Provincial de Rosario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age:9-15 year old girls and 10-17 year old boys
  • Pain Location: Anterior knee.
  • Sport Type: Jumping or kicking sport.
  • Team Member with Coach: Member of and organized team with a coach.
  • Imitation of exact pain and precise location to the tibial tuberosity with a single leg squat.
  • At least 2 months of formal and gently progressive hamstring stretching, quads strengthening, and gradual sports reintroduction.
  • Pain with sport at least 3 months.

Exclusion Criteria:

  • Patellofemoral crepitus
  • Patellar origin tenderness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care
Other: Usual Care
Therapist supervised exercises that are standard of care for Osgood-Schatter Disease as well as relative rest and gradual resumption of pain-limited sport.
Active Comparator: Lidocaine
Procedure: Lidocaine Injection
1% Lidocaine injected monthly for 3 months with a 27 gauge needle on painful areas of the tibial tuberosity, under the patellar tendon.
Active Comparator: Dextrose
Procedure: Dextrose Injection
12.5 Dextrose in 1% Lidocaine injected monthly for 3 months with a 27 gauge needle on painful areas of the tibial tuberosity, under the patellar tendon.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional de Rosario

Investigators

  • Principal Investigator: Gaston A Topol, Dr., Hospital Provincial de Rosario

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

February 22, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (Estimate)

February 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 23, 2011

Last Update Submitted That Met QC Criteria

February 22, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNRosario

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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