Skip to main content
OpenTrials
Completed

NCT Number: NCT00887003

Epidural Study of Patients With Chronic Lower Back Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Low Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton General Hospital

Hamilton, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

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

Other names: steroid

Depo-Medrol

Drug

80mg Depo-Medrol

Other names: methylprednisolone

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • St. Joseph's Healthcare Hamilton

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Apr 23, 2009
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.