Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1UL1RR024150-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Targeted enrollment was not reached.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clonidine | Experimental | Transforaminal epidural clonidine injection |
|
| Steroid | Active Comparator | Transforaminal epidural steroid injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine | Drug | 200 or 400 micrograms clonidine |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marc A Huntoon, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21192304 | Result | 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. |
Not provided
Not provided
Target enrollment was not reached
Of the 33 patients screened and randomized, 26 enrolled.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to 2 Weeks |
|
| |||||||||||||||||||||
| Baseline to 4 Weeks |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Intention to Treat (ITT) | Posted | Jun 2011 | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of Symptoms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Early termination leading to small numbers of subjects analyzed; did not measure analgesia during the expected analgesic peak of bolus administration, but 10 days after last injection; compared clonidine with an active control, rather than placebo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marc A. Huntoon | Mayo Clinic | (507) 284-2511 | huntoon.marc@mayo.edu |
Not provided
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
Not provided
Not provided
| ID | Term |
|---|---|
| D003000 | Clonidine |
| C005900 | triamcinolone hexacetonide |
| D014221 | Triamcinolone |
| D014222 | Triamcinolone Acetonide |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Triamcinolone hexacetonide | Drug | 40 or 80 milligrams triamcinolone |
|
|
| Lidocaine HCl | Drug | 1 ml 2% lidocaine (20 mg/mL) |
|
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pain Intensity Score | Pain Intensity Score as measured by Pain Intensity Numerical Rating Scale (PI-NRS). This is an 11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain). | Mean | Standard Deviation | Units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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). | Intention to Treat (ITT) | Posted | Mean | Standard Deviation | Units on a scale | 2 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Units on a scale | 2 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
|
|
|
| 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. | Intention to Treat (ITT) | Posted | Mean | Standard Deviation | Units on a scale | 2 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Units on a scale | 2 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
|
|
|
| 0 |
| 11 |
| 9 |
| 11 |
| EG001 | 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. | 0 | 15 | 11 | 15 |
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Discomfort at Injection Site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Lightheadedness | Nervous system disorders | Systematic Assessment |
|
| Drowsiness | Nervous system disorders | Systematic Assessment |
|
| Weakness | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |