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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00370799 |
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Date of registration:
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30/08/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain
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Scientific title:
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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 |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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240 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00370799 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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Phase:
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Phase 0
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Countries of recruitment
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United States
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Contacts
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Name:
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Laxmaiah Manchikanti, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ambulatory Surgery Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Low Back Pain
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Intervention(s)
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Drug: Caudal epidural injection
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Drug: Caudal Epidural Injection with Celestone
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Drug: Caudal Epidural Injection with DepoMedrol
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Drug: Caudal Epidural Injection with generic Celestone
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Primary Outcome(s)
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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
[Time Frame: 1,3,6,12 months]
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Secondary Outcome(s)
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To assess adverse events in all four groups.
[Time Frame: 1,3,6,12 months]
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Secondary ID(s)
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protocol 10
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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