Clinical trial NCT00588354: Epidural Clonidine for Lumbosacral Radiculopathy
Official title: Pilot Study of Transforaminal Epidural Injection of Clonidine for the Treatment of Acute Lumbosacral Radiculopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lumbar and Other Intervertebral Disc Disorders With Radiculopathy
Keywords: herniated disk
radiculopathy
clonidine
epidural
steroid
corticosteroid
nucleus pulposus
transforaminal
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2008-01-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)
timeFrame: 2 weeks
measure: Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire
timeFrame: 2 weeks
measure: Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire
timeFrame: 4 weeks
measure: Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)
timeFrame: 2 weeks
measure: Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire
timeFrame: 4 weeks
measure: Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)
timeFrame: 2 weeks
measure: Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Marc A Huntoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1097/BRS.0b013e3181ddd597.