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Effectiveness of Dextrose Injection for Osgood-Schlatter Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01300754
First Posted: February 23, 2011
Last Update Posted: February 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universidad Nacional de Rosario
  Purpose
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).

Condition Intervention Phase
Osgood-Schlatter Disease Procedure: Dextrose Injection Procedure: Lidocaine Injection Other: Usual Care Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Dextrose Injection for Sport-Limiting Osgood Schlatter Disease in Adolescents.

Resource links provided by NLM:


Further study details as provided by Universidad Nacional de Rosario:

Enrollment: 54
Study Start Date: January 2006
Study Completion Date: September 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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.

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.
  Eligibility

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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300754


Locations
Argentina
Hospital Provincial de Rosario
Rosario, Santa Fe, Argentina
Sponsors and Collaborators
Universidad Nacional de Rosario
Investigators
Principal Investigator: Gaston A Topol, Dr. Hospital Provincial de Rosario
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gastón Andrés Topol, M.D., Hospital Provincial de Rosario
ClinicalTrials.gov Identifier: NCT01300754     History of Changes
Other Study ID Numbers: UNRosario
First Submitted: February 22, 2011
First Posted: February 23, 2011
Last Update Posted: February 23, 2011
Last Verified: January 2011

Keywords provided by Universidad Nacional de Rosario:
Osgood-Schlatter
Tendinosis
Apophysitis
Enthesopathy
Dextrose.

Additional relevant MeSH terms:
Osteochondrosis
Bone Diseases
Musculoskeletal Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action