Effectiveness of Dextrose Injection for Osgood-Schlatter Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 2 Study of Dextrose Injection for Sport-Limiting Osgood Schlatter Disease in Adolescents.

Conditions
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Osgood-Schlatter Disease

Intervention / Treatment
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* Procedure: Dextrose Injection
* Procedure: Lidocaine Injection
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dextrose<br> | Procedure: Dextrose Injection<br>* 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.<br>|
| Active Comparator: Lidocaine<br> | Procedure: Lidocaine Injection<br>* 1% Lidocaine injected monthly for 3 months with a 27 gauge needle on painful areas of the tibial tuberosity, under the patellar tendon.<br>|
| Active Comparator: Usual Care<br> | Other: Usual Care<br>* Therapist supervised exercises that are standard of care for Osgood-Schatter Disease as well as relative rest and gradual resumption of pain-limited sport.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osgood-Schlatter, Tendinosis, Apophysitis, Enthesopathy, Dextrose.