Lumbar and Other Intervertebral Disc Disorders With RadiculopathyNCT00588354

Epidural Clonidine for Lumbosacral Radiculopathy

A study testing Clonidine, Triamcinolone hexacetonide and Lidocaine HCl in people with Lumbar and Other Intervertebral Disc Disorders With Radiculopathy, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Lumbar and Other Intervertebral Disc Disorders With Radiculopathy
What is being tested?: Clonidine, Triamcinolone hexacetonide and Lidocaine HCl
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Oct 2006to Feb 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Pilot Study of Transforaminal Epidural Injection of Clonidine for the Treatment of Acute Lumbosacral Radiculopathy

Read the 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.

Conditions: Lumbar and Other Intervertebral Disc Disorders With Radiculopathy
Being tested: Clonidine, Triamcinolone hexacetonide, Lidocaine HCl
Keywords: herniated disk, radiculopathy, clonidine, epidural, steroid, corticosteroid, nucleus pulposus, transforaminal
Medical subject headings: Intervertebral Disc Displacement, Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClonidineDrug
Also called Catapres, Kapvay, Nexiclon
200 or 400 micrograms clonidine
Triamcinolone hexacetonideDrug
Also called Aristocort, Kenacort, Tri-Nasal, Triaderm
40 or 80 milligrams triamcinolone
Lidocaine HClDrug
Also called Xylocaine, lignocaine
1 ml 2% lidocaine (20 mg/mL)

Study groups in NCT00588354
Study group	Role	What they receive
Clonidine	Experimental	Transforaminal epidural clonidine injection Receives: Drug: Clonidine; Drug: Lidocaine HCl
Steroid	Active comparator	Transforaminal epidural steroid injection Receives: Drug: Triamcinolone hexacetonide; Drug: Lidocaine HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 4 weeks

Secondary outcomes (7)

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).
Measured: 2 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006Feb 2009

First posted8 Jan 2008 (estimated)
Study startOct 2006
Primary completionFeb 2009
Study completionFeb 2009

Why it stopped: Targeted enrollment was not reached.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lumbar and Other Intervertebral Disc Disorders With RadiculopathyStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00588354
Sponsor's protocol ID: 06-002738
Other IDs: 1UL1RR024150-01
Status last verified: Dec 2011
First submitted: 26 Dec 2007
Last updated: 11 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 21192304

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Transforaminal Epidural Injection of Clonidine for the Treatment of Acute Lumbosacral Radiculopathy
ClinicalTrials.gov ID: NCT00588354
Acronym / sponsor ID: 06-002738
Conditions: Lumbar and Other Intervertebral Disc Disorders With Radiculopathy
Keywords: herniated disk, radiculopathy, clonidine, epidural, steroid, corticosteroid, nucleus pulposus, transforaminal
Study type: Interventional
Recruitment status: TerminatedReason stopped: Targeted enrollment was not reached.
Enrolment: 26 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: National Center for Research Resources (NCRR)
Study start: Oct 2006
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 8 Jan 2008 (estimated)
Results: Posted 11 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Clonidine	Experimental	Drug: Clonidine, Drug: Lidocaine HClTransforaminal epidural clonidine injection
Steroid	Active comparator	Drug: Triamcinolone hexacetonide, Drug: Lidocaine HClTransforaminal epidural steroid injection

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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:

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ClonidineAlso: Catapres, Kapvay, Nexiclon200 or 400 micrograms clonidine	Drug	Clonidine
Triamcinolone hexacetonideAlso: Aristocort, Kenacort, Tri-Nasal, Triaderm40 or 80 milligrams triamcinolone	Drug	Steroid
Lidocaine HClAlso: Xylocaine, lignocaine1 ml 2% lidocaine (20 mg/mL)	Drug	Clonidine, Steroid

Primary outcome

Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)
Time frame: 4 weeks
11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).

7 secondary outcomes

Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)
Time frame: 2 weeks
Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire
Time frame: 2 weeks
Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire
Time frame: 4 weeks
Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)
Time frame: 2 weeks
Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire
Time frame: 4 weeks
Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)
Time frame: 2 weeks
Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)
Time frame: 4 weeks

Results and safety

Results posted to the registry on 11 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2% Lidocaine and Clonidine (200 or 400 ug)	11	9
2% Lidocaine and Triamcinolone (40 mg).	15	15

Primary outcome: Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)

Time frame: 4 weeks. Mean (Standard Deviation). Unit: Units on a scale

Measure	2% Lidociane and Clonidine (200 or 400 ug) n = 9	2% Lidocaine and Triamcinolone (40 mg) n = 14
Value	4.1 (2.9)	2.7 (2.2)

2% Lidociane and Clonidine (200 or 400 ug) vs 2% Lidocaine and Triamcinolone (40 mg): Mean Difference (Net): 1.54 (95% CI -0.52 to 3.60), p = 0.159, ANCOVA

Population analysed: Intention to Treat (ITT)

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2% Lidocaine and Clonidine (200 or 400 ug)	0 of 11 (0%)	9 of 11 (81.8%)	Not reported
2% Lidocaine and Triamcinolone (40 mg).	0 of 15 (0%)	11 of 15 (73.3%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21192304Burgher 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marc A Huntoon, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00588354, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2012.