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Epidural Study of Patients With Chronic Lower Back Pain

Primary Purpose

Chronic Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Bupivacaine

Depo-Medrol

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring epidural, volume, dose, pain relief, steroid

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hamilton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

LV/LD 1

LV/HD 2

HV/LD 3

HV/HD 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

The volume and dose of local anesthetic injected epidurally, in combination with the steroid, will be measured against the duration and degree of pain relief.

Secondary Outcome Measures

Secondary outcomes will be scores on the Oswestry low back pain disability scale and the Hospital anxiety and depression scale correlated with treatment outcomes and adverse events.

Full Information

NCT ID

NCT00887003

First Posted

April 22, 2009

Last Updated

February 7, 2012

Sponsor

Hamilton Health Sciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00887003

Brief Title

Epidural Study of Patients With Chronic Lower Back Pain

Official Title

Effects of Volume and Dose of Local Anaesthetic Solution in Epidural Steroidal Injections for Patients With Chronic Lower Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low Back Pain

Keywords

epidural, volume, dose, pain relief, steroid

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

252 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LV/LD 1

Arm Type

Experimental

Arm Description

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

Arm Title

LV/HD 2

Arm Type

Experimental

Arm Description

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

Arm Title

HV/LD 3

Arm Type

Experimental

Arm Description

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

Arm Title

HV/HD 4

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Other Intervention Name(s)

steroid

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Other Intervention Name(s)

steroid

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Other Intervention Name(s)

steroid

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Other Intervention Name(s)

steroid

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Depo-Medrol

Other Intervention Name(s)

methylprednisolone

Intervention Description

80mg Depo-Medrol

Primary Outcome Measure Information:

Title

The volume and dose of local anesthetic injected epidurally, in combination with the steroid, will be measured against the duration and degree of pain relief.

Time Frame

Pain scores will be measured at 6 time intervals throughout the study period, prior to 1st injection, 30 minutes post 1st injection, prior to 2nd injection and 3rd injections and at 3 and 6 month post the three month injection.

Secondary Outcome Measure Information:

Title

Secondary outcomes will be scores on the Oswestry low back pain disability scale and the Hospital anxiety and depression scale correlated with treatment outcomes and adverse events.

Time Frame

Oswestry scores and HADS scores will be calculated at 5 time periods throughout the study period, prior to 1st, 2nd, and 3rd injections and at 3 and 6 month post the three month injection.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julian Mulcaster, MD

Organizational Affiliation

Hamilton Health Sciences Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hamilton General Hospital

City

Hamilton

State/Province

Ontario

Country

Canada

12. IPD Sharing Statement

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Epidural Study of Patients With Chronic Lower Back Pain

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