The Effects of Patient and Visit Characteristics on Health Outcomes in Knee Osteoarthritis
2 other identifiers
interventional
220
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Jan 2025
Longer than P75 for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2024
CompletedFirst Posted
Study publicly available on registry
August 27, 2024
CompletedStudy Start
First participant enrolled
January 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 27, 2028
March 30, 2026
March 1, 2026
3 years
May 15, 2024
March 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Knee Pain
Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score from the index knee at 8 weeks. Score range 0-20. Higher scores signify worse pain.
8 weeks
Knee Function
Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function score from the index knee at 8 weeks. Score range 0-68. Higher scores signify worse function.
8 weeks
Secondary Outcomes (6)
Global Impressions
30 minutes
Non-verbal Behaviors
30 minutes
Skin conductance index measure
30 minutes
Change in patient skin conductance response
30 minutes
Heart rate variability index measure
30 minutes
- +1 more secondary outcomes
Study Arms (1)
Diclofenac
EXPERIMENTALAll 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.
Interventions
Eligibility Criteria
You may qualify if:
- English-speaking
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Davislead
- National Institute on Aging (NIA)collaborator
- Beth Israel Deaconess Medical Centercollaborator
Study Sites (1)
University of California Davis Health
Sacramento, California, 95817, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Dossett, MD, PhD
University of California, Davis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2024
First Posted
August 27, 2024
Study Start
January 29, 2025
Primary Completion (Estimated)
January 27, 2028
Study Completion (Estimated)
January 27, 2028
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available following publication of those data.
- Access Criteria
- Completion of a data transfer agreement.
De-identified questionnaire and COMT genotype data will be available upon reasonable written request after publication and upon completing a data transfer agreement. Raw video and physiologic data will not be shared due to participant confidentiality/privacy.