Epidural Clonidine for Lumbosacral Radiculopathy

Condition(s) targeted: Lumbar and Other Intervertebral Disc Disorders With Radiculopathy

Intervention: Clonidine (Drug); Triamcinolone hexacetonide (Drug); Lidocaine HCl (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Marc A Huntoon, MD, Principal Investigator, Affiliation: Mayo Clinic

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.

Official title: Pilot Study of Transforaminal Epidural Injection of Clonidine for the Treatment of Acute Lumbosacral Radiculopathy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)

Secondary outcome:

Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)

Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire

Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire

Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)

Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire

Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)

Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Mayo Clinic, Rochester, Minnesota 55905, United States

Mayo Clinic Clinical Trials

Starting date: October 2006
Last updated: December 6, 2011