This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Effectiveness of Dextrose Injection for Osgood-Schlatter Disease

This study has been completed.
Information provided by:
Universidad Nacional de Rosario Identifier:
First received: February 22, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
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: Double Blind (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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01300754

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

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

Keywords provided by Universidad Nacional de Rosario:

Additional relevant MeSH terms:
Bone Diseases
Musculoskeletal Diseases
Anesthetics, Local
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 processed this record on July 19, 2017