Understanding how patient and visit characteristics affect knee osteoarthritis outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.