Effectiveness of Dextrose Injection for Osgood-Schlatter Disease
Phase 2 Study of Dextrose Injection for Sport-Limiting Osgood Schlatter Disease in Adolescents.
1 other identifier
interventional
54
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2006
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 22, 2011
CompletedFirst Posted
Study publicly available on registry
February 23, 2011
CompletedFebruary 23, 2011
January 1, 2011
3.7 years
February 22, 2011
February 22, 2011
Conditions
Keywords
Study Arms (3)
Dextrose
ACTIVE COMPARATORLidocaine
ACTIVE COMPARATORUsual Care
ACTIVE COMPARATORInterventions
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.
1% Lidocaine injected monthly for 3 months with a 27 gauge needle on painful areas of the tibial tuberosity, under the patellar tendon.
Therapist supervised exercises that are standard of care for Osgood-Schatter Disease as well as relative rest and gradual resumption of pain-limited sport.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patellofemoral crepitus
- Patellar origin tenderness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Provincial de Rosario
Rosario, Santa Fe Province, Argentina
Related Publications (1)
Topol GA, Podesta LA, Reeves KD, Raya MF, Fullerton BD, Yeh HW. Hyperosmolar dextrose injection for recalcitrant Osgood-Schlatter disease. Pediatrics. 2011 Nov;128(5):e1121-8. doi: 10.1542/peds.2010-1931. Epub 2011 Oct 3.
PMID: 21969284DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gaston A Topol, Dr.
Hospital Provincial de Rosario
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 22, 2011
First Posted
February 23, 2011
Study Start
January 1, 2006
Primary Completion
September 1, 2009
Study Completion
September 1, 2010
Last Updated
February 23, 2011
Record last verified: 2011-01