Understanding how patient and visit characteristics affect knee osteoarthritis outcomes
The Effects of Patient and Visit Characteristics on Health Outcomes in Knee Osteoarthritis
This study is testing how different factors about patients and their clinic visits can affect how well older adults with knee osteoarthritis respond to treatment with a topical gel.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT06574191 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore the relationship between patient and clinic visit characteristics and health outcomes in individuals suffering from knee osteoarthritis (OA) pain treated with topical diclofenac gel. It will involve 220 older adults who will attend two study visits, complete questionnaires, and apply the gel for eight weeks. The study will assess baseline patient characteristics, physiological responses during visits, and other visit characteristics to predict responses to treatment. Participants will also report their pain and gel usage biweekly via text messages to track changes over time.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 50 and older with radiographically confirmed knee osteoarthritis and significant knee pain.
Not a fit: Patients with medical contraindications to NSAIDs, inflammatory arthritis, or recent knee surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify which patient characteristics lead to better outcomes with topical diclofenac, potentially improving treatment strategies for knee osteoarthritis.
How similar studies have performed: Other studies have shown success in understanding treatment responses in knee osteoarthritis, but this specific approach focusing on patient and visit characteristics is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sacramento, California
- University of California Davis Health — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Michelle Dossett, MD, PhD — University of California, Davis
- Study coordinator: Maya Porter
- Email: mtporter@ucdavis.edu
- Phone: 916-734-4216
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.