Epidural Study of Patients With Chronic Lower Back Pain
NCT ID: NCT00887003
Last Updated: 2012-02-08
Study Results
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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COMPLETED
NA
252 participants
INTERVENTIONAL
2005-05-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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LV/LD 1
Low Volume, Low Dose (5cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol
Bupivacaine
Low Volume, Low Dose (5cc, 5mg plain Bupivacaine)
Depo-Medrol
80mg Depo-Medrol
LV/HD 2
Low Volume, High Dose (5cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol
Bupivacaine
Low Volume, High Dose (5cc, 10mg plain Bupivacaine)
Depo-Medrol
80mg Depo-Medrol
HV/LD 3
High Volume, Low Dose (10cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol
Bupivacaine
High Volume, Low Dose (10cc, 5mg plain Bupivacaine)
Depo-Medrol
80mg Depo-Medrol
HV/HD 4
High Volume, High Dose (10cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol
Bupivacaine
High Volume, High Dose (10cc, 10mg plain Bupivacaine)
Depo-Medrol
80mg Depo-Medrol
Interventions
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Bupivacaine
Low Volume, Low Dose (5cc, 5mg plain Bupivacaine)
Bupivacaine
Low Volume, High Dose (5cc, 10mg plain Bupivacaine)
Bupivacaine
High Volume, Low Dose (10cc, 5mg plain Bupivacaine)
Bupivacaine
High Volume, High Dose (10cc, 10mg plain Bupivacaine)
Depo-Medrol
80mg Depo-Medrol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* lower back pains \> 6 months
* no lumbar epidural in past 6 months
* no previous back surgery
* written informed consent to participate in study
Exclusion Criteria
* pregnancy
* significant psychiatric disease
* local or systemic infection
* coagulopathy/anticoagulant therapy
* bleeding diathesis
* presently enrolled in another study
18 Years
75 Years
ALL
No
Sponsors
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Hamilton Health Sciences Corporation
OTHER
Responsible Party
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Principal Investigators
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Julian Mulcaster, MD
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences Corporation
Locations
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Hamilton General Hospital
Hamilton, Ontario, Canada
Countries
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Other Identifiers
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04-392
Identifier Type: -
Identifier Source: org_study_id
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