RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-01-29
Study Completion:2028-01-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06574191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English-speaking
  2. * 50 years of age or older
  3. * Radiographically confirmed knee OA of K/L grade 2 or higher within the past 2 years
  4. * Knee pain at least 15 days/month.
  5. * Average worst daily pain 3/10 or higher over a two-week period.
  1. * 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.
  2. * Inflammatory arthritis
  3. * Partial or total knee replacement of the index knee
  4. * Recent therapeutic injection of the index knee (less than 12 weeks)
  5. * Planned knee/lower limb surgery during the two-month study period
  6. * Active cancer treatment not in remission or life expectancy less than 6 months
  7. * Inability to provide informed consent (e.g. dementia)
  8. * Current use of topical or oral NSAIDs more than 3 days per week.
  9. * Inability to receive text messages or emails to complete questionnaires between study visits.
  10. * Unable to follow the study protocol.

Contacts and Locations

Study Contact

Maya Porter
CONTACT
916-734-4216
mtporter@ucdavis.edu
Michelle Dossett, MD, PhD
CONTACT
916-734-5367
mdossett@ucdavis.edu

Principal Investigator

Michelle Dossett, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, Davis

Study Locations (Sites)

University of California Davis Health
Sacramento, California, 95817
United States

Collaborators and Investigators

Sponsor: University of California, Davis

  • Michelle Dossett, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-29
Study Completion Date2028-01-27

Study Record Updates

Study Start Date2025-01-29
Study Completion Date2028-01-27

Terms related to this study

Additional Relevant MeSH Terms

  • Knee Osteoarthritis