Epidural Clonidine for Lumbosacral Radiculopathy - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	National Center for Research Resources (NCRR)
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00588354

Purpose

This was a randomized, blinded study of transforaminal epidural injection of clonidine versus a similar injection of corticosteroid for acute lumbosacral radiculopathy. The hypothesis was that clonidine will be as effective as steroid for this condition.

Condition	Intervention
Lumbar and Other Intervertebral Disc Disorders With Radiculopathy	Drug: Clonidine Drug: Triamcinolone hexacetonide Drug: Lidocaine HCl

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Pilot Study of Transforaminal Epidural Injection of Clonidine for the Treatment of Acute Lumbosacral Radiculopathy

Resource links provided by NLM:

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

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).

Secondary Outcome Measures:

Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).
Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
This scale measures functional disability due to back pain. The score of the scale is the total number of items checked, from a minimum of 0 (no disability) to a maximum of 24 (great disability). Roland MO, Morris RW. A study of the natural history of back Pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8:141-144.
Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
This scale measures functional disability due to back pain. The score of the scale is the total number of items checked, from a minimum of 0 (no disability) to a maximum of 24 (great disability). Roland MO, Morris RW. A study of the natural history of back Pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8:141-144.
Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
This questionnaire measures a patient's permanent functional disability. The questionnaire consists of 10 sections with 6 statements each of increasing point value (from 0 to 5). The score is a percentage of the total, with higher score showing greater disability. Minimum detectable change is 10%, with a 90% CI. Change of less than this may be attributable to error in measurement.
Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
This questionnaire measures a patient's permanent functional disability. The questionnaire consists of 10 sections with 6 statements each of increasing point value (from 0 to 5). The score is a percentage of the total, with higher score showing greater disability. Minimum detectable change is 10%, with a 90% CI. Change of less than this may be attributable to error in measurement.
Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
The MPI is a comprehensive instrument comprised of 12 scales divided into three parts for assessing a number of dimensions of the chronic pain experience including pain intensity, emotional distress, cognitive and functional adaptation, and social support. Reference: Kearns RO, Turk DC, Rudy TC. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain 1985; 23:345-356. Subscales were not used; the DOS WHYMPI computer program version 2.1 was used to score the instrument. Scores range from 0 (no pain) to 100 (highest pain). A score of 50 is the mean for patients with chronic pain.
Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The MPI is a comprehensive instrument comprised of 12 scales divided into three parts for assessing a number of dimensions of the chronic pain experience including pain intensity, emotional distress, cognitive and functional adaptation, and social support. Reference: Kearns RO, Turk DC, Rudy TC. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain 1985; 23:345-356. Subscales were not used; the DOS WHYMPI computer program version 2.1 was used to score the instrument. Scores range from 0 (no pain) to 100 (highest pain). A score of 50 is the mean for patients with chronic pain.

Enrollment:	26
Study Start Date:	October 2006
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Clonidine Transforaminal epidural clonidine injection	Drug: Clonidine 200 or 400 micrograms clonidine Other Names: Catapres Kapvay Nexiclon Drug: Lidocaine HCl 1 ml 2% lidocaine (20 mg/mL) Other Names: Xylocaine lignocaine
Active Comparator: Steroid Transforaminal epidural steroid injection	Drug: Triamcinolone hexacetonide 40 or 80 milligrams triamcinolone Other Names: Aristocort Kenacort Tri-Nasal Triaderm Azmacort Trilone Volon A Tristoject Tricortone Drug: Lidocaine HCl 1 ml 2% lidocaine (20 mg/mL) Other Names: Xylocaine lignocaine

Detailed Description:

Patients with approximately 3 months of low back pain and leg pain due to intervertebral disc herniation were randomized to transforaminal epidural injections of 2% lidocaine and either clonidine (200 or 400 micrograms) or triamcinolone (40 mg) (corticosteroid). Patients received one to three injections administered at about 2 weeks apart. Patients, investigators, and study coordinators were blinded to the treatment. The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. The hypothesis was that clonidine will be as effective as steroid for this condition.

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 Straight Leg Raise (SLR) test
- 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 (This is a serious neurologic condition in which there is acute loss of function of the lumbar plexus, neurologic elements of the spinal canal below the termination of the spinal cord.)
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
Severe medical disease

Contacts and Locations

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

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Center for Research Resources (NCRR)

Investigators

Principal Investigator:

Marc A Huntoon, MD

Mayo Clinic

More Information

Additional Information:

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

Publications:

Burgher AH, Hoelzer BC, Schroeder DR, Wilson GA, Huntoon MA. Transforaminal epidural clonidine versus corticosteroid for acute lumbosacral radiculopathy due to intervertebral disc herniation. Spine (Phila Pa 1976). 2011 Mar 1;36(5):E293-300. No abstract available.

Responsible Party:	Marc A. Huntoon, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00588354 History of Changes
Other Study ID Numbers:	06-002738, 1UL1RR024150-01
Study First Received:	December 26, 2007
Results First Received:	June 3, 2011
Last Updated:	December 6, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

herniated disk
radiculopathy
clonidine
epidural

steroid
corticosteroid
nucleus pulposus
transforaminal

Additional relevant MeSH terms:

Intervertebral Disk Displacement
Intervertebral Disk Degeneration
Radiculopathy
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Clonidine
Lidocaine
Triamcinolone hexacetonide
Triamcinolone

Triamcinolone Acetonide
Triamcinolone diacetate
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 09, 2012