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Epidural Study of Patients With Chronic Lower Back Pain

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ClinicalTrials.gov Identifier: NCT00887003
Recruitment Status : Completed
First Posted : April 23, 2009
Last Update Posted : February 8, 2012
Sponsor:
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )

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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Drug: Bupivacaine Drug: Depo-Medrol Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : May 2005
Actual Primary Completion Date : August 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT00887003     History of Changes
Other Study ID Numbers: 04-392
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: July 2011

Keywords provided by McMaster University ( Hamilton Health Sciences Corporation ):
epidural
volume
dose
pain relief
steroid

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