Actively Recruiting
The Effects of Patient and Visit Characteristics on Health Outcomes in Knee Osteoarthritis
Led by University of California, Davis · Updated on 2026-03-30
220
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
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
CONDITIONS
Official Title
The Effects of Patient and Visit Characteristics on Health Outcomes in Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English-speaking
- 50 years of age or older
- Radiographically confirmed knee osteoarthritis of K/L grade 2 or higher within the past 2 years
- Knee pain at least 15 days per month
- Average worst daily pain 3/10 or higher over a two-week period
You will not qualify if you...
- Medical contraindications to NSAIDs such as recent coronary artery bypass graft, heart attack, stent placement, or stroke within 6 months
- Systolic heart failure with ejection fraction less than 45%
- Chronic kidney disease stage 4 or higher
- Severe gastrointestinal bleeding or stomach ulcer within past 6 months
- Current pregnancy
- Cirrhosis
- Currently taking blood thinners (except daily aspirin 81 mg)
- Allergy to NSAIDs or aspirin
- Any other medical reason preventing use of topical NSAIDs
- Inflammatory arthritis
- Partial or total knee replacement of the index knee
- Therapeutic injection in the index knee less than 12 weeks ago
- Planned knee or lower limb surgery during the 2-month study period
- Active cancer treatment not in remission or life expectancy under 6 months
- Unable to provide informed consent (e.g., dementia)
- Use of topical or oral NSAIDs more than 3 days per week
- Unable to receive text messages or emails for study questionnaires
- Unable to follow the study protocol
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Trial Site Locations
Total: 1 location
1
University of California Davis Health
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
M
Maya Porter
CONTACT
M
Michelle Dossett, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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