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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Drug: duloxetine; Drug: Placebo

• Registration Number: NCT00388414
• Lead Sponsor: Stanford University

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 available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-12
• Study First Submitted QC: 2006-10-13
• Study First Posted: 2006-10-16
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2017-04-22
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-07
• Last Update Submitted: 2017-11-07
• Results First Posted: 2017-12-11
• Last Update Posted: 2017-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Duloxetine	duloxetine	-
Placebo - sugar pill	Placebo	-

Primary Outcome Measures

Name	Time	Method
Pain	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	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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States