Epidural Study of Patients With Chronic Lower Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887003
• Other study ID #: 04-392
• Status: Completed
• Phase: N/A
• First received: April 22, 2009
• Last updated: February 7, 2012
• Start date: May 2005
• Est. completion date: September 2011

Study information

• Verified date: July 2011
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		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.	No
Secondary	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.		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.	No