Lumbar and Other Intervertebral Disc Disorders With Radiculopathy
Conditions
Keywords
herniated disk, radiculopathy, clonidine, epidural, steroid, corticosteroid, nucleus pulposus, transforaminal
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.
Interventions
40 or 80 milligrams triamcinolone
DRUGLidocaine HCl
1 ml 2% lidocaine (20 mg/mL)
DRUGClonidine
200 or 400 micrograms clonidine
Sponsors
National Center for Research Resources (NCRR)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS) | 4 weeks | 11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire | 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. |
| Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire | 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. |
| Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI) | 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. |
| Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS) | 2 weeks | 11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain). |
| Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI) | 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. |
| Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI) | 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. |
| Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire | 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. |
Countries
United States
Participant flow
Recruitment details
Of the 33 patients screened and randomized, 26 enrolled.
Pre-assignment details
Target enrollment was not reached
Participants by arm
| Arm | Count |
|---|---|
| 2% Lidocaine and Clonidine (200 or 400 ug) 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. Other outcomes included Patient Global Impression of Change and functional measures. | 11 |
| 2% Lidocaine and Triamcinolone (40 mg). 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. Other outcomes included Patient Global Impression of Change and functional measures. | 15 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Baseline to 2 Weeks | Adverse Event | 1 | 0 |
| Baseline to 2 Weeks | Lack of Efficacy | 1 | 0 |
| Baseline to 4 Weeks | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | 2% Lidocaine and Clonidine (200 or 400 ug) | 2% Lidocaine and Triamcinolone (40 mg). | Total |
|---|---|---|---|
| Age Continuous | 44.1 years STANDARD_DEVIATION 12.4 | 50.3 years STANDARD_DEVIATION 11 | 47.7 years STANDARD_DEVIATION 11.9 |
| Pain Intensity Score | 7.0 Units on a scale STANDARD_DEVIATION 1.9 | 7.0 Units on a scale STANDARD_DEVIATION 2 | 7.0 Units on a scale STANDARD_DEVIATION 1.9 |
| Region of Enrollment United States | 11 participants | 15 participants | 26 participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 11 | 11 / 15 |
| serious Total, serious adverse events | 0 / 11 | 0 / 15 |
Outcome results
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).
Time frame: 4 weeks
Population: Intention to Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% Lidociane and Clonidine (200 or 400 ug) | Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS) | 4.1 Units on a scale | Standard Deviation 2.9 |
| 2% Lidocaine and Triamcinolone (40 mg) | Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS) | 2.7 Units on a scale | Standard Deviation 2.2 |
Comparison: Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.p-value: 0.15995% CI: [-0.52, 3.6]ANCOVA
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.
Time frame: 2 weeks
Population: Intention to Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% Lidociane and Clonidine (200 or 400 ug) | Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI) | 27.0 Units on a scale | Standard Deviation 5.8 |
| 2% Lidocaine and Triamcinolone (40 mg) | Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI) | 21.3 Units on a scale | Standard Deviation 8.4 |
Comparison: Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.p-value: 0.08995% CI: [-0.57, 12.29]ANCOVA
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% Lidociane and Clonidine (200 or 400 ug) | Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire | 9.6 Units on a scale | Standard Deviation 5 |
| 2% Lidocaine and Triamcinolone (40 mg) | Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire | 5.7 Units on a scale | Standard Deviation 4.7 |
Comparison: Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.p-value: 0.16295% CI: [-1.04, 6.96]ANCOVA
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% Lidociane and Clonidine (200 or 400 ug) | Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire | 23.9 Units on a scale | Standard Deviation 8.3 |
| 2% Lidocaine and Triamcinolone (40 mg) | Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire | 17.0 Units on a scale | Standard Deviation 6.5 |
Comparison: Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.p-value: 0.03895% CI: [0.83, 13.25]ANCOVA
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% Lidociane and Clonidine (200 or 400 ug) | Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire | 9.4 Units on a scale | Standard Deviation 6.4 |
| 2% Lidocaine and Triamcinolone (40 mg) | Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire | 3.5 Units on a scale | Standard Deviation 4.1 |
Comparison: Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.p-value: 0.02295% CI: [1.22, 10.12]ANCOVA
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).
Time frame: 2 weeks
Population: Intention to Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% Lidociane and Clonidine (200 or 400 ug) | Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS) | 4.1 Units on a scale | Standard Deviation 2.3 |
| 2% Lidocaine and Triamcinolone (40 mg) | Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS) | 4.0 Units on a scale | Standard Deviation 2.5 |
Comparison: Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.p-value: 0.9195% CI: [-1.79, 2.01]ANCOVA
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% Lidociane and Clonidine (200 or 400 ug) | Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI) | 51.6 Units on a scale | Standard Deviation 10.2 |
| 2% Lidocaine and Triamcinolone (40 mg) | Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI) | 56.0 Units on a scale | Standard Deviation 7.2 |
Comparison: Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.p-value: 0.18695% CI: [-11.75, 2.09]ANCOVA
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% Lidociane and Clonidine (200 or 400 ug) | Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI) | 56.7 Units on a scale | Standard Deviation 6.8 |
| 2% Lidocaine and Triamcinolone (40 mg) | Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI) | 56.9 Units on a scale | Standard Deviation 8.2 |
Comparison: Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.p-value: 0.91895% CI: [-6.96, 6.26]ANCOVA