NCT06574191 The Effects of Patient and Visit Characteristics on Health Outcomes in Knee Osteoarthritis
| NCT ID | NCT06574191 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Davis |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2025-01-29 |
| Primary Completion | 2028-01-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2025-01-29 with a primary completion date of 2028-01-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to understand the patient and clinic visit characteristics that affect health outcomes for individuals with knee osteoarthritis (OA) pain using topical diclofenac gel. The main questions it aims to answer are: * What baseline patient characteristics predict response to topical diclofenac? * Does patient physiology during the study visit predict response to topical diclofenac? * Do study visit characteristics predict response to topical diclofenac? Participants will: * attend 2 study visits to complete study questionnaires and have blood drawn * apply topical diclofenac to their knee for 8 weeks * complete biweekly questions about knee pain and diclofenac use between study visits
Eligibility Criteria
Inclusion Criteria: * English-speaking * 50 years of age or older * Radiographically confirmed knee OA of K/L grade 2 or higher within the past 2 years * Knee pain at least 15 days/month. * Average worst daily pain 3/10 or higher over a two-week period. Exclusion Criteria: * Medical contraindication to taking NSAIDs such as: history of coronary artery bypass graft, myocardial infarction, coronary artery stent placement, or stroke within the past 6 months; systolic heart failure with ejection fraction \<45%; chronic kidney disease stage ≥4; severe gastrointestinal bleed or stomach ulcer within the past 6 months; current pregnancy; cirrhosis; currently taking blood thinners (aspirin 81 mg daily is okay); allergy to NSAIDs or aspirin; or any other medical contraindication to using topical NSAIDs. * Inflammatory arthritis * Partial or total knee replacement of the index knee * Recent therapeutic injection of the index knee (less than 12 weeks) * Planned knee/lower limb surgery during the two-month study period * Active cancer treatment not in remission or life expectancy less than 6 months * Inability to provide informed consent (e.g. dementia) * Current use of topical or oral NSAIDs more than 3 days per week. * Inability to receive text messages or emails to complete questionnaires between study visits. * Unable to follow the study protocol.
Contact & Investigator
Michelle Dossett, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT06574191 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06574191 currently recruiting?
Yes, NCT06574191 is actively recruiting participants. Contact the research team at mtporter@ucdavis.edu for enrollment information.
Where is the NCT06574191 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT06574191 clinical trial?
NCT06574191 is sponsored by University of California, Davis. The principal investigator is Michelle Dossett, MD, PhD at University of California, Davis. The trial plans to enroll 220 participants.