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| 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
| 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. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Target enrollment was not reached |
| 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. |
| 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 |
| 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
| 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. |
| 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
| 1. Primary: | Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS) [ Time Frame: 4 weeks ] |
| 2. Secondary: | Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS) [ Time Frame: 2 weeks ] |
| 3. Secondary: | Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire [ Time Frame: 2 weeks ] |
| 4. Secondary: | Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire [ Time Frame: 4 weeks ] |
| 5. Secondary: | Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI) [ Time Frame: 2 weeks ] |
| 6. Secondary: | Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire [ Time Frame: 4 weeks ] |
| 7. Secondary: | Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI) [ Time Frame: 2 weeks ] |
| 8. Secondary: | Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI) [ Time Frame: 4 weeks ] |
More Information
| All Principal Investigators ARE employed by the organization sponsoring the study. |
| 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. |
| 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 |