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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00388414
First Posted: October 16, 2006
Last Update Posted: December 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sean Mackey, Stanford University
  Purpose
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.

Condition Intervention
Low Back Pain Drug: duloxetine Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional MRI Neural Correlates of Medication Efficacy in Patients With Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Sean Mackey, Stanford University:

Primary Outcome Measures:
  • 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.



Enrollment: 14
Study Start Date: September 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo - sugar pill Drug: Placebo
Placebo pill once daily
Experimental: Duloxetine Drug: duloxetine
30-60mg of duloxetine daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388414


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Sean Mackey Stanford University
  More Information

Additional Information:
Responsible Party: Sean Mackey, Redlich Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00388414     History of Changes
Other Study ID Numbers: F1J-MC-I006
First Submitted: October 12, 2006
First Posted: October 16, 2006
Results First Submitted: April 22, 2017
Results First Posted: December 11, 2017
Last Update Posted: December 11, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents