Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication
|ClinicalTrials.gov Identifier: NCT00388414|
Recruitment Status : Completed
First Posted : October 16, 2006
Results First Posted : December 11, 2017
Last Update Posted : December 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Drug: duloxetine Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Functional MRI Neural Correlates of Medication Efficacy in Patients With Chronic Low Back Pain|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
|Placebo Comparator: Placebo - sugar pill||
Placebo pill once daily
30-60mg of duloxetine daily
- Pain [ Time Frame: 3 months ]
Brief Pain Inventory (BPI) scores were obtained at baseline, weeks 1, 2, 6, 7, 8, and 12, and a follow-up visit one week after completing the study.
Responses are rated on a scale from 0-10, with 0 = no pain and 10 = pain as bad as you can imagine.
Placebo and duloxetine pain scores calculated by averaging pain scores from each visit after baseline.
Values were converted to percent change in pain: [(baseline pain - end point pain)/baseline pain] x 100.
- Neural Correlates of Pain Relief [ Time Frame: 3 months ]
Scores reflect the average connectivity strength of that region of interest to the rest of the cortex.
There were no minimum or maximum values on this scale. Higher scores reflect stronger connectivity, and lower scores reflect less connectivity (all scores fell within -3 and 3).
Subscales are averaged.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388414
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Sean Mackey||Stanford University|