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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
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
Mayo Clinic

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Lumbar and Other Intervertebral Disc Disorders With Radiculopathy Drug: Clonidine Drug: Triamcinolone hexacetonide Drug: Lidocaine HCl Not Applicable

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.
Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

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


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Center for Research Resources (NCRR)
Investigators
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Principal Investigator: Marc A Huntoon, MD Mayo Clinic
More Information
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Additional Information:

Publications of Results:

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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
Keywords provided by Mayo Clinic:
herniated disk
radiculopathy
clonidine
epidural
 steroid
corticosteroid
nucleus pulposus
transforaminal
Additional relevant MeSH terms:
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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