Trial Outcomes & Findings for Epidural Clonidine for Lumbosacral Radiculopathy (NCT NCT00588354)

NCT ID: NCT00588354

Last Updated: 2012-01-11

Results Overview

11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2012-01-11

Participant Flow

Of the 33 patients screened and randomized, 26 enrolled.

Target enrollment was not reached

Participant milestones

Measure	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 to 2 Weeks STARTED	11	15
Baseline to 2 Weeks COMPLETED	9	15
Baseline to 2 Weeks NOT COMPLETED	2	0
Baseline to 4 Weeks STARTED	9	15
Baseline to 4 Weeks COMPLETED	9	14
Baseline to 4 Weeks NOT COMPLETED	0	1

Reasons for withdrawal

Measure	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 to 2 Weeks Adverse Event	1	0
Baseline to 2 Weeks Lack of Efficacy	1	0
Baseline to 4 Weeks Lost to Follow-up	0	1

Baseline Characteristics

Epidural Clonidine for Lumbosacral Radiculopathy

Baseline characteristics by cohort

Measure	2% Lidocaine and Clonidine (200 or 400 ug) n=11 Participants 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). n=15 Participants 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 n=26 Participants Total of all reporting groups
Age Continuous	44.1 years STANDARD_DEVIATION 12.4 • n=5 Participants	50.3 years STANDARD_DEVIATION 11.0 • n=7 Participants	47.7 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	15 participants n=7 Participants	26 participants n=5 Participants
Pain Intensity Score	7.0 Units on a scale STANDARD_DEVIATION 1.9 • n=5 Participants	7.0 Units on a scale STANDARD_DEVIATION 2.0 • n=7 Participants	7.0 Units on a scale STANDARD_DEVIATION 1.9 • n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Intention to Treat (ITT)

11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).

Outcome measures

Measure	2% Lidociane and Clonidine (200 or 400 ug) n=9 Participants Transforaminal epidural clonidine injection	2% Lidocaine and Triamcinolone (40 mg) n=14 Participants Transforaminal epidural steroid injection
Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)	4.1 Units on a scale Standard Deviation 2.9	2.7 Units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: 2 weeks

Population: Intention to Treat (ITT)

11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).

Outcome measures

Measure	2% Lidociane and Clonidine (200 or 400 ug) n=9 Participants Transforaminal epidural clonidine injection	2% Lidocaine and Triamcinolone (40 mg) n=15 Participants Transforaminal epidural steroid injection
Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)	4.1 Units on a scale Standard Deviation 2.3	4.0 Units on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	2% Lidociane and Clonidine (200 or 400 ug) n=9 Participants Transforaminal epidural clonidine injection	2% Lidocaine and Triamcinolone (40 mg) n=15 Participants Transforaminal epidural steroid injection
Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire	9.6 Units on a scale Standard Deviation 5.0	5.7 Units on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	2% Lidociane and Clonidine (200 or 400 ug) n=9 Participants Transforaminal epidural clonidine injection	2% Lidocaine and Triamcinolone (40 mg) n=14 Participants Transforaminal epidural steroid injection
Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire	9.4 Units on a scale Standard Deviation 6.4	3.5 Units on a scale Standard Deviation 4.1

SECONDARY outcome

Timeframe: 2 weeks

Population: Intention to Treat (ITT)

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.

Outcome measures

Measure	2% Lidociane and Clonidine (200 or 400 ug) n=9 Participants Transforaminal epidural clonidine injection	2% Lidocaine and Triamcinolone (40 mg) n=15 Participants Transforaminal epidural steroid injection
Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)	27.0 Units on a scale Standard Deviation 5.8	21.3 Units on a scale Standard Deviation 8.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	2% Lidociane and Clonidine (200 or 400 ug) n=9 Participants Transforaminal epidural clonidine injection	2% Lidocaine and Triamcinolone (40 mg) n=14 Participants Transforaminal epidural steroid injection
Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire	23.9 Units on a scale Standard Deviation 8.3	17.0 Units on a scale Standard Deviation 6.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	2% Lidociane and Clonidine (200 or 400 ug) n=9 Participants Transforaminal epidural clonidine injection	2% Lidocaine and Triamcinolone (40 mg) n=15 Participants Transforaminal epidural steroid injection
Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)	51.6 Units on a scale Standard Deviation 10.2	56.0 Units on a scale Standard Deviation 7.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	2% Lidociane and Clonidine (200 or 400 ug) n=9 Participants Transforaminal epidural clonidine injection	2% Lidocaine and Triamcinolone (40 mg) n=14 Participants Transforaminal epidural steroid injection
Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)	56.7 Units on a scale Standard Deviation 6.8	56.9 Units on a scale Standard Deviation 8.2

Adverse Events

2% Lidocaine and Clonidine (200 or 400 ug)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

2% Lidocaine and Triamcinolone (40 mg).

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	2% Lidocaine and Clonidine (200 or 400 ug) n=11 participants at risk 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). n=15 participants at risk 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.
Musculoskeletal and connective tissue disorders Worsening of Symptoms	36.4% 4/11 • Number of events 4	13.3% 2/15 • Number of events 2
Gastrointestinal disorders Constipation	18.2% 2/11 • Number of events 2	6.7% 1/15 • Number of events 1
Gastrointestinal disorders Nausea	9.1% 1/11 • Number of events 1	13.3% 2/15 • Number of events 2
Gastrointestinal disorders Dry Mouth	18.2% 2/11 • Number of events 2	20.0% 3/15 • Number of events 3
Skin and subcutaneous tissue disorders Discomfort at Injection Site	18.2% 2/11 • Number of events 2	20.0% 3/15 • Number of events 3
Nervous system disorders Lightheadedness	45.5% 5/11 • Number of events 5	6.7% 1/15 • Number of events 1
Nervous system disorders Drowsiness	18.2% 2/11 • Number of events 2	20.0% 3/15 • Number of events 3
Nervous system disorders Weakness	36.4% 4/11 • Number of events 4	6.7% 1/15 • Number of events 1

Additional Information

Dr. Marc A. Huntoon

Mayo Clinic

Phone: (507) 284-2511

Email: huntoon.marc@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place