Chronic Low Back Pain
Conditions
Keywords
epidural, volume, dose, pain relief, steroid
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.
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.
Interventions
DRUGBupivacaine
Low Volume, Low Dose (5cc, 5mg plain Bupivacaine)
DRUGDepo-Medrol
80mg Depo-Medrol
Sponsors
McMaster University
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORJulian Mulcaster, MD
Hamilton Health Sciences Corporation
Outcome results
None listed