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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00588354 |
Randomized, blinded study of transforaminal epidural injection of clonidine versus a similar injection of corticosteroid for acute lumbosacral radiculopathy. Hypothesis is that clonidine will be as effective as steroid for this condition.
Condition | Intervention |
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Acute Lumbosacral Radiculopathy Due to Herniated Disk |
Drug: clonidine Drug: triamcinolone |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Pilot Study of Transforaminal Epidural Injection of Clonidine for the Treatment of Acute Lumbosacral Radiculopathy |
Estimated Enrollment: | 40 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | November 2008 |
Arms | Assigned Interventions |
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1: Experimental
transforaminal epidural clonidine injection plus local anesthetic
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Drug: clonidine
200 or 400 micrograms clonidine and 1 milliliter 2% lidocaine, total volume of injectate 2 ml
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2: Active Comparator
transforaminal epidural steroid injection plus local anesthetic
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Drug: triamcinolone
40 milligrams triamcinolone and 1 ml 2% lidocaine, total injectate volume of 2 ml; or 80 milligrams triamcinolone and 1 ml 2% lidocaine, total injectate volume of 3ml
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Residents 18 years or older of Olmsted or contiguous counties and identified as having an acute unilateral radicular syndrome of less than 3 months duration (leg pain>back, discogenic cause, one or more of the following:
Exclusion Criteria:
Contact: Marc A Huntoon, MD | (507) 538-3270 |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Sub-Investigator: Abram H Burgher, MD | |
Principal Investigator: Marc A Huntoon, MD |
Responsible Party: | Mayo Clinic ( Marc A. Huntoon ) |
Study ID Numbers: | 06-002738, Grant Number 1 UL1 RR024150-01 |
Study First Received: | December 26, 2007 |
Last Updated: | January 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00588354 |
Health Authority: | United States: Institutional Review Board |
herniated disk radiculopathy clonidine epidural |
steroid corticosteroid nucleus pulposus transforaminal |
Spinal Diseases Clonidine Lidocaine Triamcinolone diacetate Bone Diseases Triamcinolone hexacetonide Triamcinolone Acetonide |
Musculoskeletal Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy Triamcinolone Intervertebral Disk Displacement |
Anti-Inflammatory Agents Sympatholytics Neurotransmitter Agents Adrenergic alpha-Agonists Immunologic Factors Adrenergic Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Cardiovascular Agents |
Antihypertensive Agents Immunosuppressive Agents Hormones Glucocorticoids Adrenergic Agonists Pharmacologic Actions Autonomic Agents Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents |