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Brain scans may reveal best painkiller for knee arthritis

NCT ID NCT06245109

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

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

41 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.