Epidural Clonidine for Lumbosacral Radiculopathy
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ClinicalTrials.gov Identifier: NCT00588354 |
Recruitment Status :
Terminated
(Targeted enrollment was not reached.)
First Posted : January 8, 2008
Results First Posted : January 11, 2012
Last Update Posted : January 11, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lumbar and Other Intervertebral Disc Disorders With Radiculopathy | Drug: Clonidine Drug: Triamcinolone hexacetonide Drug: Lidocaine HCl | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Pilot Study of Transforaminal Epidural Injection of Clonidine for the Treatment of Acute Lumbosacral Radiculopathy |
Study Start Date : | October 2006 |
Actual Primary Completion Date : | February 2009 |
Actual Study Completion Date : | February 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Clonidine
Transforaminal epidural clonidine injection
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Drug: Clonidine
200 or 400 micrograms clonidine
Other Names:
Drug: Lidocaine HCl 1 ml 2% lidocaine (20 mg/mL)
Other Names:
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Active Comparator: Steroid
Transforaminal epidural steroid injection
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Drug: Triamcinolone hexacetonide
40 or 80 milligrams triamcinolone
Other Names:
Drug: Lidocaine HCl 1 ml 2% lidocaine (20 mg/mL)
Other Names:
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- Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS) [ Time Frame: 4 weeks ]11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).
- Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS) [ Time Frame: 2 weeks ]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 ]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 ]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 ]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 ]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 ]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 ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00588354
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Marc A Huntoon, MD | Mayo Clinic |
Publications of Results:
Responsible Party: | Marc A. Huntoon, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00588354 |
Other Study ID Numbers: |
06-002738 1UL1RR024150-01 ( U.S. NIH Grant/Contract ) |
First Posted: | January 8, 2008 Key Record Dates |
Results First Posted: | January 11, 2012 |
Last Update Posted: | January 11, 2012 |
Last Verified: | December 2011 |
herniated disk radiculopathy clonidine epidural |
steroid corticosteroid nucleus pulposus transforaminal |
Radiculopathy Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Triamcinolone Triamcinolone Acetonide Triamcinolone hexacetonide Lidocaine Clonidine Triamcinolone diacetate Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents |
Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Analgesics Antihypertensive Agents |