The Effects of Patient and Visit Characteristics on Health Outcomes in Knee Osteoarthritis
Recruiting · NCT06574191 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, Davis
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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.
Where it is running
1 location listed across 1 US state.
- University of California Davis Health - Sacramento, California, United States