Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574191
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-15
Brief Title:
The Effects of Patient and Visit Characteristics on Health Outcomes in Knee Osteoarthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effects of Patient and Visit Characteristics on Health Outcomes in Knee Osteoarthritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None