Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain
NCT ID: NCT00370799
Last Updated: 2013-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
240 participants
INTERVENTIONAL
2007-01-31
2010-03-31
Brief Summary
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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
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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local anesthetic
Group 1. local anesthetics only
Caudal epidural injection
group 1: Caudal epidural injection local anesthetics only
Local anesthetic with generic Celestone
Group 2. local anesthetic with 6mg of non-particulate Celestone
Caudal Epidural Injection with generic Celestone
Group 2. Caudal Epidural Injection local anesthetic with 6mg of non-particulate Celestone
Local anesthetic with Celestone
Group 3. local anesthetic with 6 mg of brand nameCelestone
Caudal Epidural Injection with Celestone
Group 3. Caudal Epidural Injection with local anesthetic with 6 mg of brand name Celestone
Local anesthetic with DepoMedrol
Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
Caudal Epidural Injection with DepoMedrol
Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
Interventions
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Caudal epidural injection
group 1: Caudal epidural injection local anesthetics only
Caudal Epidural Injection with generic Celestone
Group 2. Caudal Epidural Injection local anesthetic with 6mg of non-particulate Celestone
Caudal Epidural Injection with Celestone
Group 3. Caudal Epidural Injection with local anesthetic with 6 mg of brand name Celestone
Caudal Epidural Injection with DepoMedrol
Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Pain Management Center of Paducah
OTHER
Responsible Party
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Laxmaiah Manchikanti, MD
Medical Director
Principal Investigators
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Laxmaiah Manchikanti, MD
Role: PRINCIPAL_INVESTIGATOR
Ambulatory Surgery Center
Locations
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Ambulatory Surgery Center
Paducah, Kentucky, United States
Countries
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References
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Manchikanti L, Singh V, Cash KA, Pampati V, Damron KS, Boswell MV. Effect of fluoroscopically guided caudal epidural steroid or local anesthetic injections in the treatment of lumbar disc herniation and radiculitis: a randomized, controlled, double blind trial with a two-year follow-up. Pain Physician. 2012 Jul-Aug;15(4):273-86.
Manchikanti L, Cash KA, McManus CD, Pampati V, Smith HS. One-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections with or without steroids in managing chronic discogenic low back pain without disc herniation or radiculitis. Pain Physician. 2011 Jan-Feb;14(1):25-36.
Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Management of pain of post lumbar surgery syndrome: one-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections. Pain Physician. 2010 Nov-Dec;13(6):509-21.
Other Identifiers
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protocol 10
Identifier Type: -
Identifier Source: org_study_id