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Trial record 66 of 326 for:    clonidine

Epidural Clonidine for Lumbosacral Radiculopathy

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ClinicalTrials.gov Identifier: NCT00588354
Recruitment Status : Terminated (Targeted enrollment was not reached.)
First Posted : January 8, 2008
Results First Posted : January 11, 2012
Last Update Posted : January 11, 2012
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lumbar and Other Intervertebral Disc Disorders With Radiculopathy
Interventions Drug: Clonidine
Drug: Triamcinolone hexacetonide
Drug: Lidocaine HCl
Enrollment 26
Recruitment Details Of the 33 patients screened and randomized, 26 enrolled.
Pre-assignment Details Target enrollment was not reached
Arm/Group Title 2% Lidocaine and Clonidine (200 or 400 ug) 2% Lidocaine and Triamcinolone (40 mg).
Hide Arm/Group Description

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.

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.

Period Title: Baseline to 2 Weeks
Started 11 15
Completed 9 15
Not Completed 2 0
Reason Not Completed
Adverse Event             1             0
Lack of Efficacy             1             0
Period Title: Baseline to 4 Weeks
Started 9 15
Completed 9 14
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title 2% Lidocaine and Clonidine (200 or 400 ug) 2% Lidocaine and Triamcinolone (40 mg). Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 11 15 26
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 15 participants 26 participants
44.1  (12.4) 50.3  (11.0) 47.7  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 15 participants 26 participants
Female
2
  18.2%
5
  33.3%
7
  26.9%
Male
9
  81.8%
10
  66.7%
19
  73.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 15 participants 26 participants
11 15 26
Pain Intensity Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants 15 participants 26 participants
7.0  (1.9) 7.0  (2.0) 7.0  (1.9)
[1]
Measure Description: 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).
1.Primary Outcome
Title Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)
Hide Description 11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title 2% Lidociane and Clonidine (200 or 400 ug) 2% Lidocaine and Triamcinolone (40 mg)
Hide Arm/Group Description:
Transforaminal epidural clonidine injection
Transforaminal epidural steroid injection
Overall Number of Participants Analyzed 9 14
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.1  (2.9) 2.7  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2% Lidociane and Clonidine (200 or 400 ug), 2% Lidocaine and Triamcinolone (40 mg)
Comments Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.159
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.54
Confidence Interval (2-Sided) 95%
-0.52 to 3.60
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.05
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)
Hide Description 11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title 2% Lidociane and Clonidine (200 or 400 ug) 2% Lidocaine and Triamcinolone (40 mg)
Hide Arm/Group Description:
Transforaminal epidural clonidine injection
Transforaminal epidural steroid injection
Overall Number of Participants Analyzed 9 15
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.1  (2.3) 4.0  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2% Lidociane and Clonidine (200 or 400 ug), 2% Lidocaine and Triamcinolone (40 mg)
Comments Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.910
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-1.79 to 2.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.97
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2% Lidociane and Clonidine (200 or 400 ug) 2% Lidocaine and Triamcinolone (40 mg)
Hide Arm/Group Description:
Transforaminal epidural clonidine injection
Transforaminal epidural steroid injection
Overall Number of Participants Analyzed 9 15
Mean (Standard Deviation)
Unit of Measure: Units on a scale
9.6  (5.0) 5.7  (4.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2% Lidociane and Clonidine (200 or 400 ug), 2% Lidocaine and Triamcinolone (40 mg)
Comments Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.162
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.96
Confidence Interval (2-Sided) 95%
-1.04 to 6.96
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.04
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2% Lidociane and Clonidine (200 or 400 ug) 2% Lidocaine and Triamcinolone (40 mg)
Hide Arm/Group Description:
Transforaminal epidural clonidine injection
Transforaminal epidural steroid injection
Overall Number of Participants Analyzed 9 14
Mean (Standard Deviation)
Unit of Measure: Units on a scale
9.4  (6.4) 3.5  (4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2% Lidociane and Clonidine (200 or 400 ug), 2% Lidocaine and Triamcinolone (40 mg)
Comments Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.67
Confidence Interval (2-Sided) 95%
1.22 to 10.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.27
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title 2% Lidocaine and Clonidine (200 or 400 ug) 2% Lidocaine and Triamcinolone (40 mg)
Hide Arm/Group Description:
Transforaminal epidural clonidine injection
Transforaminal epidural steroid injection
Overall Number of Participants Analyzed 9 15
Mean (Standard Deviation)
Unit of Measure: Units on a scale
27.0  (5.8) 21.3  (8.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2% Lidocaine and Clonidine (200 or 400 ug), 2% Lidocaine and Triamcinolone (40 mg)
Comments Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.089
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 5.86
Confidence Interval (2-Sided) 95%
-0.57 to 12.29
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.28
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2% Lidociane and Clonidine (200 or 400 ug) 2% Lidocaine and Triamcinolone (40 mg)
Hide Arm/Group Description:
Transforaminal epidural clonidine injection
Transforaminal epidural steroid injection
Overall Number of Participants Analyzed 9 14
Mean (Standard Deviation)
Unit of Measure: Units on a scale
23.9  (8.3) 17.0  (6.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2% Lidociane and Clonidine (200 or 400 ug), 2% Lidocaine and Triamcinolone (40 mg)
Comments Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 7.04
Confidence Interval (2-Sided) 95%
0.83 to 13.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.17
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2% Lidociane and Clonidine (200 or 400 ug) 2% Lidocaine and Triamcinolone (40 mg)
Hide Arm/Group Description:
Transforaminal epidural clonidine injection
Transforaminal epidural steroid injection
Overall Number of Participants Analyzed 9 15
Mean (Standard Deviation)
Unit of Measure: Units on a scale
51.6  (10.2) 56.0  (7.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2% Lidociane and Clonidine (200 or 400 ug), 2% Lidocaine and Triamcinolone (40 mg)
Comments Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.186
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.83
Confidence Interval (2-Sided) 95%
-11.75 to 2.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.53
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2% Lidociane and Clonidine (200 or 400 ug) 2% Lidocaine and Triamcinolone (40 mg)
Hide Arm/Group Description:
Transforaminal epidural clonidine injection
Transforaminal epidural steroid injection
Overall Number of Participants Analyzed 9 14
Mean (Standard Deviation)
Unit of Measure: Units on a scale
56.7  (6.8) 56.9  (8.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2% Lidociane and Clonidine (200 or 400 ug), 2% Lidocaine and Triamcinolone (40 mg)
Comments Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.918
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-6.96 to 6.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.37
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2% Lidocaine and Clonidine (200 or 400 ug) 2% Lidocaine and Triamcinolone (40 mg).
Hide Arm/Group Description

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.

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.

All-Cause Mortality
2% Lidocaine and Clonidine (200 or 400 ug) 2% Lidocaine and Triamcinolone (40 mg).
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
2% Lidocaine and Clonidine (200 or 400 ug) 2% Lidocaine and Triamcinolone (40 mg).
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
2% Lidocaine and Clonidine (200 or 400 ug) 2% Lidocaine and Triamcinolone (40 mg).
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/11 (81.82%)      11/15 (73.33%)    
Gastrointestinal disorders     
Constipation   2/11 (18.18%)  2 1/15 (6.67%)  1
Nausea   1/11 (9.09%)  1 2/15 (13.33%)  2
Dry Mouth   2/11 (18.18%)  2 3/15 (20.00%)  3
Musculoskeletal and connective tissue disorders     
Worsening of Symptoms   4/11 (36.36%)  4 2/15 (13.33%)  2
Nervous system disorders     
Lightheadedness   5/11 (45.45%)  5 1/15 (6.67%)  1
Drowsiness   2/11 (18.18%)  2 3/15 (20.00%)  3
Weakness   4/11 (36.36%)  4 1/15 (6.67%)  1
Skin and subcutaneous tissue disorders     
Discomfort at Injection Site   2/11 (18.18%)  2 3/15 (20.00%)  3
Indicates events were collected by 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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Marc A. Huntoon
Organization: Mayo Clinic
Phone: (507) 284-2511
EMail: huntoon.marc@mayo.edu
Layout table for additonal information
Responsible Party: Marc A. Huntoon, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588354     History of Changes
Other Study ID Numbers: 06-002738
1UL1RR024150-01 ( U.S. NIH Grant/Contract )
First Submitted: December 26, 2007
First Posted: January 8, 2008
Results First Submitted: June 3, 2011
Results First Posted: January 11, 2012
Last Update Posted: January 11, 2012