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
  Purpose

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.


Condition Intervention
Chronic Low Back Pain
Drug: Bupivacaine
Drug: Depo-Medrol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Volume and Dose of Local Anaesthetic Solution in Epidural Steroidal Injections for Patients With Chronic Lower Back Pain

Resource links provided by NLM:


Further study details as provided by McMaster University:

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. [ 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 ]

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. [ 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 ]

Enrollment: 252
Study Start Date: May 2005
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LV/LD 1
Low Volume, Low Dose (5cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol
Drug: Bupivacaine
Low Volume, Low Dose (5cc, 5mg plain Bupivacaine)
Other Name: steroid
Drug: Depo-Medrol
80mg Depo-Medrol
Other Name: methylprednisolone
Experimental: LV/HD 2
Low Volume, High Dose (5cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol
Drug: Bupivacaine
Low Volume, High Dose (5cc, 10mg plain Bupivacaine)
Other Name: steroid
Drug: Depo-Medrol
80mg Depo-Medrol
Other Name: methylprednisolone
Experimental: HV/LD 3
High Volume, Low Dose (10cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol
Drug: Bupivacaine
High Volume, Low Dose (10cc, 5mg plain Bupivacaine)
Other Name: steroid
Drug: Depo-Medrol
80mg Depo-Medrol
Other Name: methylprednisolone
Experimental: HV/HD 4
High Volume, High Dose (10cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol
Drug: Bupivacaine
High Volume, High Dose (10cc, 10mg plain Bupivacaine)
Other Name: steroid
Drug: Depo-Medrol
80mg Depo-Medrol
Other Name: methylprednisolone

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887003

Locations
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Julian Mulcaster, MD Hamilton Health Sciences Corporation
  More Information

No publications provided

Responsible Party: McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier: NCT00887003     History of Changes
Other Study ID Numbers: 04-392
Study First Received: April 22, 2009
Last Updated: February 7, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
epidural
volume
dose
pain relief
steroid

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Bupivacaine
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics
Anesthetics, Local
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2014