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Effectiveness of Dextrose Injection for Osgood-Schlatter Disease

This study has been completed.
Sponsor:
Information provided by:
Universidad Nacional de Rosario
ClinicalTrials.gov Identifier:
NCT01300754
First received: February 22, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Ages Eligible for Study:   9 Years to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Universidad Nacional de Rosario

Additional 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
Study First Received: February 22, 2011
Last Updated: February 22, 2011
Health Authority: Argentina: Universidad National de Rosario
Argentina: Comite de Bioetica del Hospital Provincial(Rosario)
Argentina: Comite de Investigacion y Docencia del Hospital Provincial de Rosario

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
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013