Brain scans may reveal best painkiller for knee arthritis
NCT ID NCT06245109
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to find out if brain-based tests can predict who will get pain relief from common knee osteoarthritis treatments. About 180 adults with knee pain will be randomly assigned to take duloxetine, celecoxib, or a placebo for 20 weeks. Researchers will use brain MRIs, knee X-rays, blood tests, and pain sensitivity checks to look for clues that predict treatment success.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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41 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female, age greater than 40 years, with no racial/ethnic restrictions; 2. Meet American College of Radiology criteria for knee osteoarthritis (OA) based on radiographic evidence; 3. Knee pain most days of the week for the past month at screening; 4. Must have average pain score for the week prior to baseline of ≥ 4.0 (on a 0 to 10 Numeric Rating Scale) 5. Must complete pain ratings on at least 4 out of 7 days prior to baseline; 6. Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires; 7. Must be in generally stable health; 8. Must be able to return for all clinic visits; 9. Willing to remain stable on any concomitant therapies (Transcutaneous Electrical Nerve Stimulation (TENS) unit, ice, glucosamine chondroitin, cannabinoids, etc.); 10. 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; 11. Ambulatory with or without a cane, brace(s), or walking stick (use of walker or wheelchair will be exclusionary); 12. Glucagon-like peptide 1 (GLP-1) agonists or other weight-loss treatment permitted if started more than 3 months prior to screening with no significant change in weight (+/- 11 lbs) over the past 30 days; Exclusion Criteria: 1. Evidence of rheumatoid arthritis, ankylosing spondylitis, other inflammatory arthropathy; 2. Functional class IV congestive heart failure; 3. Significant other medical disease such as uncontrolled hypertension, untreated diabetes mellitus, coronary or peripheral vascular disease, chronic obstructive lung disease, or liver disease (liver function tests \> upper limit of normal); 4. Current use of illicit drugs or history (in last 12 months) of alcohol or drug abuse; 5. Current cannabinoid use for knee pain; 6. High dose opioid use, as defined as \> 50mg morphine equivalent/day; 7. Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk; 8. In the judgment of the investigator, unable or unwilling to follow protocol and instructions; 9. Intra-axial implants (e.g., spinal cord stimulators or pumps); 10. Currently breastfeeding, pregnant, or planning to become pregnant during the study; 11. Chronic neurologic conditions, e.g., Parkinson's; 12. Renal insufficiency (creatinine \>1.5 mg/dl); 13. Previous history of peptic ulcer or gastrointestinal bleeding; 14. Current use of anticoagulants or platelet inhibitors other than aspirin at ≤325 mg/day; 15. Allergy to sulfonamide drugs, duloxetine, nonsteroidal anti-inflammatory drugs (NSAIDs), or acetaminophen; 16. Acute myocardial infarction or coronary artery bypass graft surgery, in the past 12 months; 17. Recent injection into the index knee of hyaluronic acid or other substance in the last 6 months, or steroid in the last 90 days; 18. Lactose allergy; 19. Current use of selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and/or tricyclic antidepressants (TCAs) at a therapeutic dose. Occasional use of these medications as a sleep aid will be allowed; however, participants will need to agree to remain on a stable dose of the medication while in the study; 20. Uncontrolled narrow-angle glaucoma; 21. Malignancy within 2 years of screening, with the exception of squamous cell carcinoma, basal cell carcinoma and prostate cancer (grade group 1); 22. Active treatment for cancer other than superficial skin cancer; or 23. Nerve ablation performed on the index knee within 12 months of screening.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Northwestern University
RECRUITINGChicago, Illinois, 60611, United States
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