Summary

Eligibility
for people ages 50 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around
Principal Investigator
by Michelle Dossett, MD, PhD (ucdavis)
Headshot of Michelle Dossett
Michelle Dossett

Description

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 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

Details

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 visits and measure participant heart rate and skin conductance during the visit. Participants will complete baseline questionnaires immediately prior to the study visit. All participants will receive diclofenac gel (a topical over-the-counter non-steroidal anti-inflammatory drug [NSAID]), a guideline recommended treatment for knee OA-related pain at the end of the first study visit. Participants will identify an "index" knee (worst pain, right or left) that they will treat and follow during the study. Between study visit 1 and the 8-week follow-up visit, participants will receive an every other week text message asking them to report on pain and diclofenac use to better understand changes in pain over time. Final questionnaires will be completed at the second study visit at week 8.

Keywords

Knee Osteoarthritis, Osteoarthritis, Diclofenac, Topical Diclofenac gel 1%

Eligibility

You can join if…

Open to people ages 50 years and up

  • 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.

You CAN'T join if...

  • Medical contraindication to taking NSAIDs such as: history of coronary artery bypass graft, myocardial infarction, 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, or allergy to NSAIDs or aspirin.
  • Active cancer treatment 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 email.

Location

  • University of California Davis Health
    Sacramento California 95817 United States

Lead Scientist at University of California Health

  • Michelle Dossett, MD, PhD (ucdavis)
    My research is focused in two primary areas. The first, in understanding the mechanisms by which enhanced patient-clinician interactions contribute to improved health outcomes for patients.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT06574191
Study Type
Interventional
Participants
Expecting 220 study participants
Last Updated