Investigating Pain Treatments for Knee Osteoarthritis

Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis

This study is testing whether the pain medications duloxetine and celecoxib can help people with knee osteoarthritis feel better compared to a placebo.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 41 Years and up
• Sex: All
• Sponsor: Northwestern University (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06245109 on ClinicalTrials.gov

What this trial studies

This clinical trial at Northwestern University Feinberg School of Medicine aims to evaluate the effectiveness of duloxetine, celecoxib, and a placebo in treating knee osteoarthritis pain. Over a 20-week period, 180 participants will be randomly assigned to one of the three treatment groups. The study will involve various assessments, including X-rays, MRIs, blood draws, and pain sensitivity testing, to identify biomarkers that predict treatment response. The goal is to better understand which patients will benefit from specific pain medications.

Who should consider this trial

Good fit: Ideal candidates are individuals over 40 years old with knee osteoarthritis pain occurring most days of the week and a pain score of 4 or higher.

Not a fit: Patients with knee osteoarthritis who do not experience significant pain or those unable to comply with study requirements may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective pain management strategies for patients with knee osteoarthritis.

How similar studies have performed: Other studies have shown promise in using biomarkers to predict treatment responses in osteoarthritis, suggesting this approach may be viable.

Eligibility criteria

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.

Where this trial is running

Chicago, Illinois

• Northwestern University — Chicago, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Thomas J Schnitzer, MD, PhD — Northwestern University
• Study coordinator: Graeme Witte

Conditions Knee Osteoarthritis; knee oa; knee osteoarthritis; osteoarthritis; knee pain