Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis
This is a clinical trial of people who have pain due to knee osteoarthritis at Northwestern University Feinberg School of Medicine. The study will last for about 20 weeks. 180 qualified participants will be randomly assigned in a 1:1:1 ratio (60 participants per group) to one of three treatment groups: duloxetine, celecoxib, or placebo. Participants will have an Xray, knee MRI, brain MRI, blood draws, pain sensitivity testing, and asked to fill out questionnaires. The purpose of this study is to try to predict which participants will respond to the treatment.
• Male or female, age greater than 40 years, with no racial/ethnic restrictions;
• Meet American College of Radiology (ACR) criteria for knee osteoarthritis (OA) based on radiographic evidence;
• Knee pain most days of the week for the past month at screening;
• Must have average pain score for the week prior to baseline of ≥ 4 (on a 0 to 10 NRS)
• Must complete pain ratings on at least 4 out of 7 days prior to baseline
• Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires;
• Must be in generally stable health;
• Must be able to return for all clinic visits;
• Willing to remain stable on any concomitant therapies (TENs unit, ice, glucosamine chondroitin, cannabinoids, etc.)
⁃ Must sign an informed consent document after complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate.
⁃ Ambulatory with or without a cane, brace(s), or walking stick (use of walker or wheelchair will be exclusionary)