Status:
RECRUITING
The Effects of Patient and Visit Characteristics on Health Outcomes in Knee Osteoarthritis
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
National Institute on Aging (NIA)
Beth Israel Deaconess Medical Center
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
50+ years
Phase:
NA
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 ge...
Detailed 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 visit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 27 2028
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06574191
Start Date
January 29 2025
End Date
January 27 2028
Last Update
March 17 2025
Active Locations (1)
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1
University of California Davis Health
Sacramento, California, United States, 95817