Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT05098158
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2020-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Community-Engaged Options to Facilitate Opioid Reduction
Sponsor:
Washington State University
Organization:
Study Overview
Official Title:
Community-Engaged Options to Maximize and Facilitate Opioid Reduction Through Treatment
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMFORT
Brief Summary:
This study investigates how adults prescribed opioids for chronic noncancer pain respond to invitations to try non-opioid options of massage therapy, yoga therapy, chiropractic and physical therapies. Options will be available via telehealth consultation visits using a computer or smartphone with internet connection. The investigators will measure effects on pain, pain-related symptoms, and opioid use over time using a single-group design.
Detailed Description:
Participants will be recruited from local primary care practices and asked to complete a baseline survey. They will then meet with a registered nurse via teleconference for a complete pain assessment. At the end of the session, participants will be asked to choose two of four available modalities for telehealth consultation. Participants will be scheduled for six telehealth sessions, once per week x six weeks with three consultations per each chosen therapy. Measurements of pain, mood, sleep, medicine use will be captured at baseline, three weeks and six weeks and examined for changes over time.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: