Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain
A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Caudal Epidural Injections in Lumbar Disc Herniations, Spinal Stenosis, Discogenic Pain, and Post-Lumbar Laminectomy Syndrome
1 other identifier
interventional
240
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jan 2007
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2006
CompletedFirst Posted
Study publicly available on registry
September 1, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedAugust 16, 2013
August 1, 2013
2.9 years
August 30, 2006
August 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To assess adverse events in all four groups.
1,3,6,12 months
Study Arms (4)
local anesthetic
ACTIVE COMPARATORGroup 1. local anesthetics only
Local anesthetic with generic Celestone
ACTIVE COMPARATORGroup 2. local anesthetic with 6mg of non-particulate Celestone
Local anesthetic with Celestone
ACTIVE COMPARATORGroup 3. local anesthetic with 6 mg of brand nameCelestone
Local anesthetic with DepoMedrol
ACTIVE COMPARATORGroup 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
Interventions
group 1: Caudal epidural injection local anesthetics only
Group 2. Caudal Epidural Injection local anesthetic with 6mg of non-particulate Celestone
Group 3. Caudal Epidural Injection with local anesthetic with 6 mg of brand name Celestone
Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ambulatory Surgery Center
Paducah, Kentucky, 42001, United States
Related Publications (3)
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.
PMID: 22828681DERIVEDManchikanti 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.
PMID: 21267039DERIVEDManchikanti 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.
PMID: 21102963DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laxmaiah Manchikanti, MD
Ambulatory Surgery Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
August 30, 2006
First Posted
September 1, 2006
Study Start
January 1, 2007
Primary Completion
December 1, 2009
Study Completion
March 1, 2010
Last Updated
August 16, 2013
Record last verified: 2013-08