Back to resultsImaging Study of Chronic Low Back Pain in Patients Taking Pain Medication
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
duloxetine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:- Males aged 18-60
- Back Pain
- Must be able to comply with study visit schedule and other study requirements
- Capable of performing the experimental tasks Exclusion Criteria:- Contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body)
- Known hypersensitivity to duloxetine or any of the inactive ingredients
- Uncontrolled narrow-angle glaucoma
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo - sugar pill
Duloxetine
Arm Description
Outcomes
Primary Outcome Measures
Pain
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00388414
Brief Title
Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication
Official Title
Functional MRI Neural Correlates of Medication Efficacy in Patients With Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
Brief Summary
Duloxetine has recently been shown to be effective in reducing the pain in chronic pain patients. Duloxetine is known to exert a central mechanism, however the precise human brain structures responsible for mediating its pain-relieving properties are not known. We will use functional magnetic resonance imaging (FMRI) to investigate the neural and functional correlates of pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo - sugar pill
Arm Type
Placebo Comparator
Arm Title
Duloxetine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
duloxetine
Intervention Description
30-60mg of duloxetine daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo pill once daily
Primary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
3 months
Title
Neural Correlates of Pain Relief
Description
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.
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- Males aged 18-60
Back Pain
Must be able to comply with study visit schedule and other study requirements
Capable of performing the experimental tasks Exclusion Criteria:- Contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body)
Known hypersensitivity to duloxetine or any of the inactive ingredients
Uncontrolled narrow-angle glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Mackey
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Links:
URL
http://snapl.stanford.edu/
Description
Description of the study and recruitment details
Learn more about this trial
Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication
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