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Completed

NCT Number: NCT00388414

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duloxetine

Drug

30-60mg of duloxetine daily

Placebo

Drug

Placebo pill once daily

Primary outcomes

  1. Pain

    Time frame: 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.

  2. Neural Correlates of Pain Relief

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Oct 16, 2006
Registry last updated
Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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