Epidural Clonidine for Lumbosacral Radiculopathy

This study has been terminated.

( Targeted enrollment was not reached. )

Study NCT00588354 Information provided by Mayo Clinic

First Received on December 26, 2007. Last Updated on December 6, 2011 History of Changes

Results First Received: June 3, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Lumbar and Other Intervertebral Disc Disorders With Radiculopathy
Interventions:	Drug: Clonidine Drug: Triamcinolone hexacetonide Drug: Lidocaine HCl

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Of the 33 patients screened and randomized, 26 enrolled.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Target enrollment was not reached

Reporting Groups

	Description
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.
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.

Description

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.

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.

Participant Flow for 2 periods

Period 1: Baseline to 2 Weeks

	2% Lidocaine and Clonidine (200 or 400 ug)	2% Lidocaine and Triamcinolone (40 mg).
STARTED	11	15
COMPLETED	9	15
NOT COMPLETED	2	0
Adverse Event	1	0
Lack of Efficacy	1	0

Period 2: Baseline to 4 Weeks

	2% Lidocaine and Clonidine (200 or 400 ug)	2% Lidocaine and Triamcinolone (40 mg).
STARTED	9	15
COMPLETED	9	14
NOT COMPLETED	0	1
Lost to Follow-up	0	1

Baseline Characteristics

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Reporting Groups

	Description
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.
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.

Description

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.

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.

Baseline Measures

	2% Lidocaine and Clonidine (200 or 400 ug)	2% Lidocaine and Triamcinolone (40 mg).	Total
Number of Participants [units: participants]	11	15	26
Age [units: years] Mean ± Standard Deviation	44.1 ± 12.4	50.3 ± 11.0	47.7 ± 11.9
Gender [units: participants]
Female	2	5	7
Male	9	10	19
Region of Enrollment [units: participants]
United States	11	15	26
Pain Intensity Score ^[1] [units: Units on a scale] Mean ± Standard Deviation	7.0 ± 1.9	7.0 ± 2.0	7.0 ± 1.9

[1]	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).

Outcome Measures

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1. Primary:

Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS) [ Time Frame: 4 weeks ]

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2. Secondary:

Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS) [ Time Frame: 2 weeks ]

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3. Secondary:

Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire [ Time Frame: 2 weeks ]

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4. Secondary:

Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire [ Time Frame: 4 weeks ]

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5. Secondary:

Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI) [ Time Frame: 2 weeks ]

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6. Secondary:

Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire [ Time Frame: 4 weeks ]

Show Outcome Measure 6

7. Secondary:

Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI) [ Time Frame: 2 weeks ]

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8. Secondary:

Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI) [ Time Frame: 4 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

Results Point of Contact:

Name/Title: Dr. Marc A. Huntoon
Organization: Mayo Clinic
phone: (507) 284-2511
e-mail: huntoon.marc@mayo.edu

Publications of Results:

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. No abstract available.

Responsible Party:	Marc A. Huntoon, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00588354 History of Changes
Other Study ID Numbers:	06-002738, 1UL1RR024150-01
Study First Received:	December 26, 2007
Results First Received:	June 3, 2011
Last Updated:	December 6, 2011
Health Authority:	United States: Institutional Review Board