Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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: Double Blind (Subject, 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 Stanford University:

Primary Outcome Measures:
  • Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Neural correlates of pain relief [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 53
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

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sean Mackey, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00388414     History of Changes
Other Study ID Numbers: F1J-MC-I006
Study First Received: October 12, 2006
Last Updated: June 21, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014