Epidural Study of Patients With Chronic Lower Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier:
NCT00887003
First received: April 22, 2009
Last updated: February 7, 2012
Last verified: July 2011

April 22, 2009
February 7, 2012
May 2005
August 2011   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00887003 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Epidural Study of Patients With Chronic Lower Back Pain
Effects of Volume and Dose of Local Anaesthetic Solution in Epidural Steroidal Injections for 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Low Back Pain
  • Drug: Bupivacaine
    Low Volume, Low Dose (5cc, 5mg plain Bupivacaine)
    Other Name: steroid
  • Drug: Bupivacaine
    Low Volume, High Dose (5cc, 10mg plain Bupivacaine)
    Other Name: steroid
  • Drug: Bupivacaine
    High Volume, Low Dose (10cc, 5mg plain Bupivacaine)
    Other Name: steroid
  • Drug: Bupivacaine
    High Volume, High Dose (10cc, 10mg plain Bupivacaine)
    Other Name: steroid
  • Drug: Depo-Medrol
    80mg Depo-Medrol
    Other Name: methylprednisolone
  • Experimental: LV/LD 1
    Low Volume, Low Dose (5cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol
    Interventions:
    • Drug: Bupivacaine
    • Drug: Depo-Medrol
  • Experimental: LV/HD 2
    Low Volume, High Dose (5cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol
    Interventions:
    • Drug: Bupivacaine
    • Drug: Depo-Medrol
  • Experimental: HV/LD 3
    High Volume, Low Dose (10cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol
    Interventions:
    • Drug: Bupivacaine
    • Drug: Depo-Medrol
  • Experimental: HV/HD 4
    High Volume, High Dose (10cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol
    Interventions:
    • Drug: Bupivacaine
    • Drug: Depo-Medrol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
252
September 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00887003
04-392
No
McMaster University ( Hamilton Health Sciences Corporation )
Hamilton Health Sciences Corporation
Not Provided
Principal Investigator: Julian Mulcaster, MD Hamilton Health Sciences Corporation
McMaster University
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP