Epidural Clonidine for Lumbosacral Radiculopathy - Full Text View

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00588354

Purpose

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
Acute Lumbosacral Radiculopathy Due to Herniated Disk	Drug: clonidine Drug: triamcinolone

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Clonidine Clonidine hydrochloride Triamcinolone hexacetonide

U.S. FDA Resources

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

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Numerical Rating Scale (NRS) of pain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient Global Impression of Change (PGIC) [ Time Frame: 2 - 12 weeks ] [ Designated as safety issue: No ]
Oswestry Low Back Pain Disability Questionnaire [ Time Frame: 2 - 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2006
Estimated Study Completion Date:	November 2008

Arms	Assigned Interventions
1: Experimental transforaminal epidural clonidine injection plus local anesthetic	Drug: clonidine 200 or 400 micrograms clonidine and 1 milliliter 2% lidocaine, total volume of injectate 2 ml
2: Active Comparator transforaminal epidural steroid injection plus local anesthetic	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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:
- Positive SLR
- Myotomal weakness
- Dermatomal sensory loss) and with concordant
- Confirmatory findings on recent MRI or CT myelogram

Exclusion Criteria:

History of recent spinal trauma
Cauda equina syndrome
Progressive neurological deficit
Motor deficit
Pathological or infectious etiology
Involvement in workers' compensation claim
History of adverse reaction to corticosteroids, local anesthetic or clonidine
History of one or more corticosteroid injection(s) (equivalent to 40 mg of triamcinolone acetate) in the preceding 4 months
Pregnant; OR
Severe medical disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588354

Contacts

Contact: Marc A Huntoon, MD

(507) 538-3270

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Sub-Investigator: Abram H Burgher, MD
Principal Investigator: Marc A Huntoon, MD

Sponsors and Collaborators

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

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 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

herniated disk
radiculopathy
clonidine
epidural

steroid
corticosteroid
nucleus pulposus
transforaminal

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Immunologic Factors
Adrenergic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Diseases
Hormones
Adrenergic Agonists
Triamcinolone hexacetonide
Triamcinolone Acetonide
Neuromuscular Diseases
Musculoskeletal Diseases
Triamcinolone

Radiculopathy
Analgesics
Intervertebral Disk Displacement
Spinal Diseases
Adrenergic alpha-Agonists
Clonidine
Lidocaine
Triamcinolone diacetate
Cardiovascular Agents
Antihypertensive Agents
Immunosuppressive Agents
Glucocorticoids
Peripheral Nervous System Diseases
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neurotransmitter Agents
Immunologic Factors
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Bone Diseases
Adrenergic Agonists
Triamcinolone hexacetonide
Triamcinolone Acetonide
Neuromuscular Diseases
Musculoskeletal Diseases
Sensory System Agents

Therapeutic Uses
Triamcinolone
Radiculopathy
Analgesics
Intervertebral Disk Displacement
Spinal Diseases
Sympatholytics
Adrenergic alpha-Agonists
Clonidine
Nervous System Diseases
Enzyme Inhibitors
Triamcinolone diacetate
Cardiovascular Agents
Antihypertensive Agents
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 07, 2009