University of California Davis Health
Sacramento, California, 95817, United States
Location status: Recruiting
NCT Number: NCT06574191
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
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
Sacramento, California, 95817, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Topical NSAID
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 30 minutes
Baseline-adjusted end of visit global impression ratings from study visit video recordings. Each global impression is measured on a 1-9 scale. Global impressions include engagement (clinician and patient), friendliness (clinician and patient), relaxed (clinician and patient), empathic (clinician), reciprocity (dyad), business-like (clinician), dominant (clinician), rushed/hurried (clinician), bored/uninterested (clinician), confident (patient), and pleased (patient). We will construct a Global Impression Summative Scale Score if a preliminary round of psychometric evaluation determines that a combination of the individual construct scores can be constructed that has adequate internal consistency and unidimensionality.
Time frame: 30 minutes
Baseline-adjusted end of visit non-verbal behaviors from study visit video recordings. Each non-verbal behavior is measured as counts (number of times) or total length of time within a discrete period of time (i.e., 2 minutes) from the video. Nonverbal behaviors that will be counted or timed for both parties include: gaze duration and number, smile duration and number, number of nods, self-touch, and gestures. We will also assess the number of clinician backchannel responses while patients spoke, the number of instances of shared laughter between the dyads, and the length of time that both the patient and clinician spoke. We will construct a Non-verbal Behavior Summative Score if a preliminary round of psychometric evaluation determines that a combination of the individual construct scores can be constructed that has adequate internal consistency and unidimensionality.
Time frame: 30 minutes
Concordance in skin conductance response (measured in micro Siemens) from electrodes attached to the patient's and clinician's fingers over the course of the study visit will be calculated using an established approach (Marci CD, 2007; PMID 17299296) to create a single index value for the visit. The natural logarithm of this value will be taken to reduce skew. A value greater than 0 means more than 50% concordance in the data, a value less than zero means less than 50% concordance in the data.
Time frame: 30 minutes
Change in patient skin conductance response from beginning to end of the initial study visit in micro-Siemens as measured by skin electrodes. Change score will be calculated as mean skin conductance response for the first 2 minutes of the study visit minus the mean value for the last 2 minutes of the study visit.
Time frame: 30 minutes
Concordance in heart rate variability, measured from electrodes attached to the patient and clinician, over the course of the study visit, will be calculated using established approaches (see references below). Concordance is quantified by the degree to which heart rate variability of the patient and clinician are "in-phase" or "anti-phase" linked (i.e., coordinated changes in the same or opposite direction) along the study visits.
https://pubmed.ncbi.nlm.nih.gov/29683720/ https://pubmed.ncbi.nlm.nih.gov/21910541/ https://pubmed.ncbi.nlm.nih.gov/24708502/ https://pubmed.ncbi.nlm.nih.gov/35315937/
Time frame: 30 minutes
The RMSSD component (proxy for high frequency heart rate variability) will be measured in the patient over the course of the study visit. Change score will be calculated as mean RMSSD value for the first 5 minutes of the study visit minus the mean value for the last 5 minutes of the study visit.
Contact information is provided by the study sponsor or research team.
Maya Porter
CONTACT
Michelle Dossett, MD, PhD
CONTACT
University of California, Davis
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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