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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388414
• Other study ID #: F1J-MC-I006
• Status: Completed
• Phase: N/A
• First received: October 12, 2006
• Last updated: November 7, 2017
• Start date: September 2006
• Est. completion date: January 2010

Study information

• Verified date: November 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	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.	3 months
Primary	Neural Correlates of Pain Relief	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.	3 months

External Links

•   Description of the study and recruitment details