Effectiveness of Dextrose Injection for Osgood-Schlatter Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2010-09-30

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).

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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.

Conditions

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Osgood-Schlatter Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dextrose

Group Type ACTIVE_COMPARATOR

Dextrose Injection

Intervention Type PROCEDURE

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.

Lidocaine

Group Type ACTIVE_COMPARATOR

Lidocaine Injection

Intervention Type PROCEDURE

1% Lidocaine injected monthly for 3 months with a 27 gauge needle on painful areas of the tibial tuberosity, under the patellar tendon.

Usual Care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Therapist supervised exercises that are standard of care for Osgood-Schatter Disease as well as relative rest and gradual resumption of pain-limited sport.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

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.

Intervention Type OTHER

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.