Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University
ClinicalTrials.gov Identifier:
NCT00388414
First received: October 12, 2006
Last updated: June 21, 2012
Last verified: June 2012

October 12, 2006
June 21, 2012
September 2006
January 2010   (final data collection date for primary outcome measure)
  • Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Neural correlates of pain relief [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00388414 on ClinicalTrials.gov Archive Site
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Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication
Functional MRI Neural Correlates of Medication Efficacy in Patients With Chronic Low Back Pain

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.

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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Low Back Pain
  • Drug: duloxetine
    30-60mg of duloxetine daily
  • Drug: Placebo
    Placebo pill once daily
  • Placebo Comparator: Placebo - sugar pill
    Intervention: Drug: Placebo
  • Experimental: Duloxetine
    Intervention: Drug: duloxetine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00388414
F1J-MC-I006
Not Provided
Sean Mackey, Stanford University
Stanford University
Not Provided
Principal Investigator: Sean Mackey Stanford University
Stanford University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP