NCT01300754CompletedPhase 1
Phase 2 Study of Dextrose Injection for Sport-Limiting Osgood Schlatter Disease in Adolescents.
Universidad Nacional de Rosario1 site in 1 country54 target enrollmentStarted: January 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 54
- Locations
- 1
Study Overview
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).
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 9 Years to 17 Years (Child)
- Sex
- 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
Investigators
Study Sites (1)
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