The Effects of Patient and Visit Characteristics on Health Outcomes in Knee Osteoarthritis
University of California, Davis
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
Description
220 older adults with symptomatic knee OA will attend a single research clinic visit (one of four different types of study visits) with a study clinician. The investigators will video record the visits and measure participant heart rate and skin conductance during the visit. Participants will complete baseline questionnaires immediately prior to the study visit. All participants will receive diclofenac gel (a topical over-the-counter non-steroidal anti-inflammatory drug \[NSAID\]), a guideline recommended treatment for knee OA-related pain at the end of the first study visit. Participants will…
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
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 with…
Interventions
- DrugTopical Diclofenac gel 1%
Topical NSAID
Location
- University of California Davis HealthSacramento, California