Brain Morphometry in OA Patients Treated With Duloxetine
- Conditions
- PainOsteoarthritis
- Interventions
- Drug: DuloxetineDrug: Placebo Oral Tablet
- Registration Number
- NCT02903238
- Lead Sponsor
- Northwestern University
- Brief Summary
This is a two week,single-blind study evaluating pain response and changes in brain imaging upon treatment with placebo in people with knee OA.
- Detailed Description
In this study, all the participants will be receiving placebo. However this study will be single blinded in that participants will be told that they will be given a pill that may or may not help with their pain. The researcher, however, will know that all participants are receiving placebo
At the initial visit, participants will undergo screening to determine that they meet all inclusion and exclusion criteria. They will sign consent and then complete pain assessment instruments as well as one high resolution anatomical scan (T1) and one functional scan (a resting scar) in a 3 Tesla magnet. A single scanning session comprised of a 10 minute functional scan (a resting scan) will be done two weeks from the first scan and pain assessment instruments will be completed at this visit as well. After finishing this second scan (done two weeks after the initial scan), the participants will have completed the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- Age: 40-85 years
- ACR criteria for OA including Kellgren-Lawrence radiographic OA grades II-IV
- VAS pain score >5/10 within 48 hrs of the phone screen and visit 1 (Screening)
- Knee OA for a minimum of 12 months
- Need for daily pain medication to manage symptoms of OA
- Currently taking MAO inhibitors or any centrally acting drug for analgesia
- Narrow angle glaucoma
- Uncontrolled hypertension
- Co-existing inflammatory arthritis, fibromyalgia or other chronic pain state
- If a female, pregnant, trying to become pregnant, or lactating
- Major depressive disorder
- Substantial alcohol use or history of significant liver disease
- Diabetes, type 1 or type 2
- Condition in which the Investigator believes would interfere with the subject's ability to comply with study instructions, or might confound the interpretation of the study results or put the subject at undue risk
- Standard MRI safety exclusions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo Oral Tablet placebo capsule Placebo Duloxetine placebo capsule
- Primary Outcome Measures
Name Time Method Brain Regional Gray Matter Density 2 weeks Gray matter density (GMD) of the prefrontal cortex region identified as placebo biomarker. Placebo responders/non-responders were identified based on the VAS score. A minimum of 20% decrease in VAS score was needed to be qualified as responders.
GMD is a value between 0 and 1 representing the intensity of every brain voxels. The GMD of the prefrontal cortex region represent the average GMD of every voxels in this region.
- Secondary Outcome Measures
Name Time Method Overall Brain Neocortical Gray Matter Volume 2 weeks WOMAC Pain Index 2 weeks Osteoarthritis (OA) specific pain and quality of life index (the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC). The WOMAC score is from 0 to 96 where 0 represent no pain and quality of life impairment due to OA and 96 represent the worst pain and quality of life impairment due to OA. The outcome is reported as the percent change from baseline to end of treatment (2 weeks).
Trial Locations
- Locations (1)
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States