Actively Recruiting
Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis
Led by Northwestern University · Updated on 2026-04-30
180
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
B
Brigham and Women's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 a knee Xray, (optional) MRIs of the brain and knee, 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.
CONDITIONS
Official Title
Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age greater than 40 years, with no racial/ethnic restrictions
- Meet American College of Radiology criteria for knee osteoarthritis based on X-ray evidence
- Experience knee pain most days of the week for the past month at screening
- Average pain score of 4 or higher on a 0 to 10 scale during the week before baseline
- Completed pain ratings on at least 4 out of 7 days before baseline
- Able to read, speak English, and understand study instructions and questionnaires
- Generally in stable health
- Able to return for all clinic visits
- Willing to remain stable on any current therapies such as TENS, ice, glucosamine, or cannabinoids
- Signed informed consent after understanding study purpose, procedures, risks, and benefits
- Ambulatory with or without cane, brace(s), or walking stick (walker or wheelchair use excluded)
- If using GLP-1 agonists or weight-loss treatments, started more than 3 months prior with no major weight change in last 30 days
You will not qualify if you...
- Diagnosis of rheumatoid arthritis, ankylosing spondylitis, or other inflammatory joint diseases
- Functional class IV congestive heart failure
- Serious medical conditions such as uncontrolled high blood pressure, untreated diabetes, heart or vascular disease, lung disease, or liver disease
- Current illicit drug use or history of alcohol/drug abuse in last 12 months
- Current use of cannabinoids for knee pain
- High dose opioid use above 50 mg morphine equivalent per day
- Any medical condition that could prevent study completion or cause undue risk
- Unable or unwilling to follow study instructions
- Presence of intra-axial implants like spinal cord stimulators or pumps
- Pregnant, breastfeeding, or planning pregnancy during study
- Chronic neurological diseases such as Parkinson's
- Kidney problems with creatinine above 1.5 mg/dl
- History of peptic ulcers or gastrointestinal bleeding
- Current use of anticoagulants or platelet inhibitors except low-dose aspirin
- Allergies to sulfonamide drugs, duloxetine, NSAIDs, or acetaminophen
- Recent heart attack or coronary bypass surgery within the past year
- Recent injections into the study knee within specified time frames
- Allergy to lactose
- Current use of certain antidepressants at therapeutic doses, except occasional sleep aid use
- Uncontrolled narrow-angle glaucoma
- Cancer diagnosis within past 2 years except certain skin or low-grade prostate cancers
- Active cancer treatments other than superficial skin cancer
- Nerve ablation on the study knee within the past 12 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
G
Graeme Witte
CONTACT
N
Narina Simonian, BS, CCRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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