Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain
- Conditions
- Low Back Pain
- Interventions
- Drug: Caudal epidural injectionDrug: Caudal Epidural Injection with generic CelestoneDrug: Caudal Epidural Injection with CelestoneDrug: Caudal Epidural Injection with DepoMedrol
- Registration Number
- NCT00370799
- Lead Sponsor
- Pain Management Center of Paducah
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description local anesthetic Caudal epidural injection Group 1. local anesthetics only Local anesthetic with generic Celestone Caudal Epidural Injection with generic Celestone Group 2. local anesthetic with 6mg of non-particulate Celestone Local anesthetic with Celestone Caudal Epidural Injection with Celestone Group 3. local anesthetic with 6 mg of brand nameCelestone Local anesthetic with DepoMedrol Caudal Epidural Injection with DepoMedrol Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To assess adverse events in all four groups. 1,3,6,12 months
Trial Locations
- Locations (1)
Ambulatory Surgery Center
🇺🇸Paducah, Kentucky, United States