NCT01300754

Effectiveness of Dextrose Injection for Osgood-Schlatter Disease

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Universidad Nacional de Rosario · Academic / Other
• Sex: All
• Age: 9 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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).

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.

Conditions

• Osgood-Schlatter Disease

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2006-01-01
• Primary completion: 2009-09-01
• Completion: 2010-09-01
• First posted: 2011-02-23
• Last updated: 2011-02-23

Locations

1 site across 1 country: Argentina