The Effects of Patient and Visit Characteristics on Health Outcomes in Knee Osteoarthritis

Last updated: March 12, 2025
Sponsor: University of California, Davis
Overall Status: Active - Recruiting

Phase

N/A

Condition

Knee Injuries

Osteoarthritis

Treatment

Topical Diclofenac gel

Topical Diclofenac gel 1%

Clinical Study ID

NCT06574191
2054088
R01AG078283
  • Ages > 50
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Medical contraindication to taking NSAIDs such as: history of coronary artery bypassgraft, myocardial infarction, coronary artery stent placement, or stroke within thepast 6 months; systolic heart failure with ejection fraction <45%; chronic kidneydisease stage ≥4; severe gastrointestinal bleed or stomach ulcer within the past 6months; current pregnancy; cirrhosis; currently taking blood thinners (aspirin 81 mgdaily is okay); allergy to NSAIDs or aspirin; or any other medical contraindicationto 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 betweenstudy visits.

  • Unable to follow the study protocol.

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: Topical Diclofenac gel
Phase:
Study Start date:
January 29, 2025
Estimated Completion Date:
January 27, 2028

Study Description

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.

Connect with a study center

  • University of California Davis Health

    Sacramento, California 95817
    United States

    Active - Recruiting

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