Trial · NCT00588354

Epidural Clonidine for Lumbosacral Radiculopathy

NCT00588354, Not applicable, Terminated, Mayo Clinic; results first posted 2012-01-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Epidural Clonidine for Lumbosacral Radiculopathy. Trials, record NCT00588354. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00588354

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Epidural Clonidine for Lumbosacral Radiculopathy
NCT number: NCT00588354
Status: Terminated
Phases: Not applicable
Enrollment: 26 participants, actual
Lead sponsor: Mayo Clinic
Conditions: Lumbar and Other Intervertebral Disc Disorders With Radiculopathy
Interventions: Clonidine, Triamcinolone hexacetonide, Lidocaine HCl
First posted: 2008-01-08
Last updated: 2012-01-11
Results first posted: 2012-01-11
Limitations and caveats: 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.

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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).
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)	4 weeks	Intention to Treat (ITT)	Units on a scale	MEAN
SECONDARY	Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)	2 weeks	Intention to Treat (ITT)	Units on a scale	MEAN
SECONDARY	Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire	2 weeks		Units on a scale	MEAN
SECONDARY	Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire	4 weeks		Units on a scale	MEAN
SECONDARY	Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)	2 weeks	Intention to Treat (ITT)	Units on a scale	MEAN
SECONDARY	Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire	4 weeks		Units on a scale	MEAN
SECONDARY	Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)	2 weeks		Units on a scale	MEAN
SECONDARY	Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)	4 weeks		Units on a scale	MEAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)	2% Lidociane and Clonidine (200 or 400 ug)	4.1	Standard Deviation 2.9	Units on a scale
Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)	2% Lidocaine and Triamcinolone (40 mg)	2.7	Standard Deviation 2.2	Units on a scale
Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)	2% Lidociane and Clonidine (200 or 400 ug)	4.1	Standard Deviation 2.3	Units on a scale
Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)	2% Lidocaine and Triamcinolone (40 mg)	4.0	Standard Deviation 2.5	Units on a scale
Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire	2% Lidociane and Clonidine (200 or 400 ug)	9.6	Standard Deviation 5.0	Units on a scale
Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire	2% Lidocaine and Triamcinolone (40 mg)	5.7	Standard Deviation 4.7	Units on a scale
Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire	2% Lidociane and Clonidine (200 or 400 ug)	9.4	Standard Deviation 6.4	Units on a scale
Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire	2% Lidocaine and Triamcinolone (40 mg)	3.5	Standard Deviation 4.1	Units on a scale
Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)	2% Lidocaine and Clonidine (200 or 400 ug)	27.0	Standard Deviation 5.8	Units on a scale
Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)	2% Lidocaine and Triamcinolone (40 mg)	21.3	Standard Deviation 8.4	Units on a scale

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Baseline to 2 Weeks	STARTED	2% Lidocaine and Clonidine (200 or 400 ug)	11
Baseline to 2 Weeks	STARTED	2% Lidocaine and Triamcinolone (40 mg).	15
Baseline to 2 Weeks	COMPLETED	2% Lidocaine and Clonidine (200 or 400 ug)	9
Baseline to 2 Weeks	COMPLETED	2% Lidocaine and Triamcinolone (40 mg).	15
Baseline to 2 Weeks	NOT COMPLETED	2% Lidocaine and Clonidine (200 or 400 ug)	2
Baseline to 2 Weeks	NOT COMPLETED	2% Lidocaine and Triamcinolone (40 mg).	0
Baseline to 4 Weeks	STARTED	2% Lidocaine and Clonidine (200 or 400 ug)	9
Baseline to 4 Weeks	STARTED	2% Lidocaine and Triamcinolone (40 mg).	15
Baseline to 4 Weeks	COMPLETED	2% Lidocaine and Clonidine (200 or 400 ug)	9
Baseline to 4 Weeks	COMPLETED	2% Lidocaine and Triamcinolone (40 mg).	14

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Worsening of Symptoms	Musculoskeletal and connective tissue disorders	2% Lidocaine and Clonidine (200 or 400 ug)	4	11	4
other	Worsening of Symptoms	Musculoskeletal and connective tissue disorders	2% Lidocaine and Triamcinolone (40 mg).	2	15	2
other	Constipation	Gastrointestinal disorders	2% Lidocaine and Clonidine (200 or 400 ug)	2	11	2
other	Constipation	Gastrointestinal disorders	2% Lidocaine and Triamcinolone (40 mg).	1	15	1
other	Nausea	Gastrointestinal disorders	2% Lidocaine and Clonidine (200 or 400 ug)	1	11	1
other	Nausea	Gastrointestinal disorders	2% Lidocaine and Triamcinolone (40 mg).	2	15	2
other	Dry Mouth	Gastrointestinal disorders	2% Lidocaine and Clonidine (200 or 400 ug)	2	11	2
other	Dry Mouth	Gastrointestinal disorders	2% Lidocaine and Triamcinolone (40 mg).	3	15	3
other	Discomfort at Injection Site	Skin and subcutaneous tissue disorders	2% Lidocaine and Clonidine (200 or 400 ug)	2	11	2
other	Discomfort at Injection Site	Skin and subcutaneous tissue disorders	2% Lidocaine and Triamcinolone (40 mg).	3	15	3

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	2% Lidocaine and Clonidine (200 or 400 ug)
Total, all-cause mortality	2% Lidocaine and Triamcinolone (40 mg).
Total, other adverse events	2% Lidocaine and Clonidine (200 or 400 ug)	9	11
Total, other adverse events	2% Lidocaine and Triamcinolone (40 mg).	11	15
Total, serious adverse events	2% Lidocaine and Clonidine (200 or 400 ug)	0	11
Total, serious adverse events	2% Lidocaine and Triamcinolone (40 mg).	0	15

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21192304	RESULT

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UL1RR024150	Mayo Clinic Center for Translational Science Activities	RIZZA, ROBERT A.	MAYO CLINIC ROCHESTER	NATIONAL CENTER FOR RESEARCH RESOURCES	2006 to 2011

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
2% Lidocaine and Clonidine (200 or 400 ug) vs 2% Lidocaine and Triamcinolone (40 mg).: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00588354

GET https://conductscience.org/api/trials/v1/NCT00588354/registered

API reference For AI assistants