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

NCT ID: NCT00388414

Last Updated: 2017-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-01-31

Brief Summary

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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

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo - sugar pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo pill once daily

Duloxetine

Group Type EXPERIMENTAL

duloxetine

Intervention Type DRUG

30-60mg of duloxetine daily

Interventions

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duloxetine

30-60mg of duloxetine daily

Intervention Type DRUG

Placebo

Placebo pill once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Back Pain
* Must be able to comply with study visit schedule and other study requirements

Exclusion Criteria

* Known hypersensitivity to duloxetine or any of the inactive ingredients
* Uncontrolled narrow-angle glaucoma
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Sean Mackey

Redlich Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sean Mackey

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Related Links

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http://snapl.stanford.edu/

Description of the study and recruitment details

Other Identifiers

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F1J-MC-I006

Identifier Type: -

Identifier Source: org_study_id