Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333938
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2023-12-13
Brief Title:
Veterans Enhanced Recovery Using Integrative Treatments Around Surgery
Sponsor:
Durham VA Medical Center
Organization:
Durham VA Medical Center
Study Overview
Official Title:
An Effectiveness-Implementation Hybrid Pilot Study on Masimo Bridge Versus the VADoD Battlefield Acupuncture Treatment for Perioperative Pain Management
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
VERITAS
Brief Summary:
The study aims to assess the effectiveness of NSS2-Bridge in postoperative pain management in comparison to Battlefield Acupuncture BFA
Detailed Description:
There is an urgent need for effective safe and low-cost nonpharmacologic treatments for postoperative pain This study aims to measure the implementation and effectiveness of Masimo Bridge versus Battlefield Acupuncture BFA The Bridge device requires less provider training and delivers treatment for 5 days whereas BFA requires provider training and maintenance of competence and the duration of effects are unknown We expect that implementation and effectiveness outcomes will be similar or will favor the Bridge device
Patients from the Durham Veterans Affairs Medical Center Durham VAMC scheduled to undergo total knee arthroplasty TKA will be eligible to participate in this study A sample of 60 veterans will studied over six months We will offer BFA versus Bridge on alternate months and recruitment will end when 40 patients have received the Bridge and at least 20 have received BFA
Patients from the Durham Veterans Affairs Medical Center Durham VAMC scheduled to undergo total knee arthroplasty TKA will be eligible to participate in this study A sample of 60 veterans will studied over six months We will offer BFA versus Bridge on alternate months and recruitment will end when 40 patients have received the Bridge and at least 20 have received BFA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None