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

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ClinicalTrials.gov Identifier: NCT00388414
Recruitment Status : Completed
First Posted : October 16, 2006
Results First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University

October 12, 2006
October 16, 2006
April 22, 2017
December 11, 2017
December 11, 2017
September 2006
January 2010   (Final data collection date for primary outcome measure)
  • 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.

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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
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
14
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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
Sexes Eligible for Study: Male
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00388414
F1J-MC-I006
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Sean Mackey, Stanford University
Stanford University
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Principal Investigator: Sean Mackey Stanford University
Stanford University
November 2017

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