Epidural Clonidine for Lumbosacral Radiculopathy
This study has been terminated.
(Targeted enrollment was not reached.)
Sponsor:
Mayo Clinic
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588354
First received: December 26, 2007
Last updated: December 6, 2011
Last verified: December 2011
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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
Lidocaine hydrochloride
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:
Drug: Lidocaine HCl
1 ml 2% lidocaine (20 mg/mL)
Other Names:
|
|
Active Comparator: Steroid
Transforaminal epidural steroid injection
|
Drug: Triamcinolone hexacetonide
40 or 80 milligrams triamcinolone
Other Names:
Drug: Lidocaine HCl
1 ml 2% lidocaine (20 mg/mL)
Other Names:
|
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 (Adult, Senior) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00588354
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:
Publications:
| 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:
|
Radiculopathy Intervertebral Disc Displacement Intervertebral Disc Degeneration Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Spinal Diseases Bone Diseases Musculoskeletal Diseases Hernia Pathological Conditions, Anatomical Lidocaine Clonidine Triamcinolone hexacetonide Triamcinolone |
Triamcinolone Acetonide 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 |
ClinicalTrials.gov processed this record on September 23, 2016