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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 50 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Criteria:

  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06574191
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of California, Davis
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Michelle Dossett, MD, PhD
Principal Investigator Affiliation University of California, Davis
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Knee Osteoarthritis
Additional 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.

Arms & Interventions

Arms

Experimental: Diclofenac

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.

Interventions

Drug: - Topical Diclofenac gel 1%

Topical NSAID

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California Davis Health, Sacramento, California

Status

Recruiting

Address

University of California Davis Health

Sacramento, California, 95817

Site Contact

Michelle Dossett, MD, PhD, MPH

[email protected]

916-734-5367

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