Brain Morphometry in OA Patients Treated With Duloxetine

Northwestern University

Status: Completed

Conditions: Osteoarthritis; Pain

Treatments: Drug: Duloxetine; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02903238

STU00039556A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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21 participants in 1 patient group

Placebo

Experimental group

Description:

placebo capsule

Treatment:

Drug: Placebo Oral Tablet

Drug: Duloxetine