N/A
N=14
Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT00388414 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Pain — -1; -43 Percentage change from baseline to end
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- duloxetine (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Stanford University
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain |
-1; -43 | — |
| PRIMARY Neural Correlates of Pain Relief |
0.521; 0.466; 0.468; 0.485; 0.492; 0.469 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00388414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.