Lumbar and Other Intervertebral Disc Disorders With Radiculopathy Clinical Trial
Official title:
Pilot Study of Transforaminal Epidural Injection of Clonidine for the Treatment of Acute Lumbosacral Radiculopathy
| Verified date | December 2011 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 26 |
| Est. completion date | February 2009 |
| Est. primary completion date | February 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic | National Center for Research Resources (NCRR) |
United States,
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/ — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS) | 11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain). | 4 weeks | No |
| Secondary | Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS) | 11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain). | 2 weeks | No |
| Secondary | Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire | 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. | 2 weeks | No |
| Secondary | Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire | 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 weeks | No |
| Secondary | Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI) | 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. | 2 weeks | No |
| Secondary | Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire | 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. | 4 weeks | No |
| Secondary | Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI) | 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. | 2 weeks | No |
| Secondary | Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI) | 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. | 4 weeks | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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