Diclofenac Gel for Osteoarthritis

Recruiting in Palo Alto (17 mi)

Overseen byMichelle Dossett, MD, PhD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Davis

No Placebo Group

Trial Summary

What is the purpose of this trial?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

Eligibility Criteria

This trial is for individuals with knee osteoarthritis who are willing to apply diclofenac gel on their knee and can attend two study visits. Participants will also need to answer biweekly questions about their knee pain and treatment usage.

Inclusion Criteria

English-speaking

I experience knee pain for at least 15 days each month.

I am 50 years old or older.

+1 more

Exclusion Criteria

I use NSAID medications more than three times a week.

Inability to receive text messages or email

I cannot take NSAIDs due to a serious health condition or allergy.

+2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Study Visit

Participants attend the first study visit to complete baseline questionnaires, have blood drawn, and receive diclofenac gel

1 day

1 visit (in-person)

Treatment

Participants apply topical diclofenac to their knee for 8 weeks and complete biweekly questions about knee pain and diclofenac use

8 weeks

Biweekly virtual check-ins

Follow-up

Participants attend a follow-up visit to complete final questionnaires and assess outcomes

1 day

1 visit (in-person)

Participant Groups

The study aims to determine how patient characteristics, physiological responses during clinic visits, and the nature of these visits influence the effectiveness of topical diclofenac gel in managing knee OA pain.

1Treatment groups

Experimental Treatment

Group I: DiclofenacExperimental Treatment1 Intervention

All study participants receiving topical diclofenac gel 1%. Participants will be instructed to apply 4 grams of the gel to the index knee at least once per day, and up to 4 times per day, for 8 weeks.