Epidural Clonidine for Lumbosacral Radiculopathy

This study has been terminated.
(Targeted enrollment was not reached.)
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588354
First received: December 26, 2007
Last updated: December 6, 2011
Last verified: December 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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:
Intervertebral Disc Degeneration
Intervertebral Disc Displacement
Radiculopathy
Bone Diseases
Hernia
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Pathological Conditions, Anatomical
Peripheral Nervous System Diseases
Spinal Diseases
Clonidine
Lidocaine
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Anti-Inflammatory Agents
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 23, 2014