Epidural Study of Patients With Chronic Lower Back Pain

NCT ID: NCT00887003

Last Updated: 2012-02-08

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

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2011-09-30

Brief Summary

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The purpose of this study is to examine 4 different epidural dosing regimes of local anaesthetic solution in a series of 3 epidural injections over a period of 12 months to determine the optimum dose of anaesthetic solution for pain relief and to determine the nature of any adverse events by measuring anxiety and depression, functionality and any side effects of the medication.

Detailed Description

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To determine the optimum dose of local anesthetic and the optimum volume of injected solution when used in an epidural steroid injection being given for pain relief to patients with chronic lower back pain, using pain scores as an assessment tool.

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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LV/LD 1

Low Volume, Low Dose (5cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

Low Volume, Low Dose (5cc, 5mg plain Bupivacaine)

Depo-Medrol

Intervention Type DRUG

80mg Depo-Medrol

LV/HD 2

Low Volume, High Dose (5cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

Low Volume, High Dose (5cc, 10mg plain Bupivacaine)

Depo-Medrol

Intervention Type DRUG

80mg Depo-Medrol

HV/LD 3

High Volume, Low Dose (10cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

High Volume, Low Dose (10cc, 5mg plain Bupivacaine)

Depo-Medrol

Intervention Type DRUG

80mg Depo-Medrol

HV/HD 4

High Volume, High Dose (10cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

High Volume, High Dose (10cc, 10mg plain Bupivacaine)

Depo-Medrol

Intervention Type DRUG

80mg Depo-Medrol

Interventions

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Bupivacaine

Low Volume, Low Dose (5cc, 5mg plain Bupivacaine)

Intervention Type DRUG

Bupivacaine

Low Volume, High Dose (5cc, 10mg plain Bupivacaine)

Intervention Type DRUG

Bupivacaine

High Volume, Low Dose (10cc, 5mg plain Bupivacaine)

Intervention Type DRUG

Bupivacaine

High Volume, High Dose (10cc, 10mg plain Bupivacaine)

Intervention Type DRUG

Depo-Medrol

80mg Depo-Medrol

Intervention Type DRUG

Other Intervention Names

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steroid steroid steroid steroid methylprednisolone

Eligibility Criteria

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Inclusion Criteria

* 18-75 years old
* 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

* acute lower back pain
* pregnancy
* significant psychiatric disease
* local or systemic infection
* coagulopathy/anticoagulant therapy
* bleeding diathesis
* presently enrolled in another study
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Canada

Other Identifiers

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04-392

Identifier Type: -

Identifier Source: org_study_id

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