Low Back Pain
Conditions
Keywords
Caudal Epidural injections, lumbar disc herniation, spinal stenosis, discogenic pain, post-lumbar laminectomy syndrome
Brief summary
To demonstrate clinically significant improvements or lack thereof in the caudal epidural patients with our without steroids. To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids. To assess improvements among patients and compare steroid groups with each other and local anesthetic group. To evaluate and compare the adverse event profile in all patients
Detailed description
Patients with chronic low back pain of at least 6 months duration, non-responsive to conservative management with NSAIDS, physical therapy or chiropractic treatment exercises. A single-center, prospective, controlled, double blinded, randomized study of patients in 4 groups. * Group 1. local anesthetics only * Group 2. local anesthetic with 6mg of non-particulate Celestone * Group 3. local anesthetic with 6 mg of brand name Celestone * Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol All patients will be unblinded in 12 months. Non-responsive patients will be unblinded after 3 months and will be crossed over to a different group
Interventions
group 1: Caudal epidural injection local anesthetics only
DRUGCaudal Epidural Injection with generic Celestone
Group 2. Caudal Epidural Injection local anesthetic with 6mg of non-particulate Celestone
DRUGCaudal Epidural Injection with Celestone
Group 3. Caudal Epidural Injection with local anesthetic with 6 mg of brand name Celestone
DRUGCaudal Epidural Injection with DepoMedrol
Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
Sponsors
Pain Management Center of Paducah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * History of chronic, function-limiting low back pain of at least 6 months duration * Able to give voluntary, written informed consent to participate, * Able to understand the investigation, cooperate with the procedures, and willing to return for follow-up * No recent surgical procedures within last three months
Exclusion criteria
* Cauda Equina symptoms and/or compressive radiculopathy * Narcotic use of no greater than 100mg/day hydrocodone, 60mg Methadone. or 100mg morphine * Uncontrolled major Depression or uncontrolled psychiatric disorder * Uncontrolled or acute medical illnesses * Chronic severe conditions that could interfere with outcome assessments * Women who are pregnant or lactating * Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment * Patients with multiple complaints involving concomitant hip osteoarthritis * Inability to achieve proper positioning and inability to understand informed consent and protocol * History of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate for differences between the patients in various groups in the physical function and pain at 1, 3, 6, and 12 months post treatment | 1,3,6,12 months |
Secondary
| Measure | Time frame |
|---|---|
| To assess adverse events in all four groups. | 1,3,6,12 months |
Countries
United States
Outcome results
None listed