Effectiveness of Dextrose Injection for Osgood-Schlatter Disease

Osgood-Schlatter Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300754
• Other study ID #: UNRosario
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 22, 2011
• Last updated: February 22, 2011
• Start date: January 2006
• Est. completion date: September 2010

Study information

• Verified date: January 2011
• Source: Universidad Nacional de Rosario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Universidad National de RosarioArgentina: Comite de Bioetica del Hospital Provincial(Rosario)Argentina: Comite de Investigacion y Docencia del Hospital Provincial de Rosario
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osgood-Schlatter Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Argentina	Hospital Provincial de Rosario	Rosario	Santa Fe

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional de Rosario

Country where clinical trial is conducted

Argentina,