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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 12, 2006

Last Updated Date

June 21, 2012

Start Date ^ICMJE

September 2006

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00388414 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Functional MRI Neural Correlates of Medication Efficacy in Patients With Chronic Low Back Pain

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Low Back Pain

Intervention ^ICMJE

Drug: duloxetine
30-60mg of duloxetine daily
Drug: Placebo
Placebo pill once daily

Study Arm (s)

Placebo Comparator: Placebo - sugar pill
Intervention: Drug: Placebo
Experimental: Duloxetine
Intervention: Drug: duloxetine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2010

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00388414

Other Study ID Numbers ^ICMJE

F1J-MC-I006

Has Data Monitoring Committee

Not Provided

Responsible Party

Sean Mackey, Stanford University

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Sean Mackey

Stanford University

Information Provided By

Stanford University

Verification Date

June 2012

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

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