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

Stanford University

Status: Completed

Conditions: Low Back Pain

Treatments: Drug: Placebo; Drug: duloxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT00388414

F1J-MC-I006

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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14 participants in 2 patient groups, including a placebo group

Placebo - sugar pill

Placebo Comparator group

Treatment:

Drug: Placebo

Duloxetine

Experimental group

Treatment:

Drug: duloxetine