Veterans Enhanced Recovery Using Integrative Treatments Around Surgery (VERITAS)

An Effectiveness-Implementation Hybrid Pilot Study on Masimo Bridge® Versus the VA/DoD Battlefield Acupuncture Treatment for Perioperative Pain Management

The study aims to assess the effectiveness of NSS2-Bridge in postoperative pain management in comparison to Battlefield Acupuncture (BFA).

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery; Anesthesia; Knee Arthropathy
• Intervention / Treatment: Device: Bridge; Device: 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Karthik Raghunathan, MD MPH; Phone Number: 2158507220; Email: karthik.raghunathan@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Veterans Scheduled to undergo knee join replacement (TKA)

Exclusion Criteria:

• Risk of Bleeding
• Patients with cardiac pacemakers
• Patients with psoriasis vulgaris

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bridge; Experimental - 30 participants will receive the Bridge device, up to 10 patients per month	Device: Bridge; Percutaneous Nerve Field Stimulation using a disposable battery operated and device, approved by the FDA for the treatment of clinical symptoms related to opioid withdrawal.
Active Comparator: Battlefield Acupuncture (BFA); 30 participants will receive BFA, up to 10 patients per month	Device: BFA; BFA is an auricular acupuncture technique (developed within the VA/ DoD health systems) delivered by providers using 1mm acupuncture needles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and Pain Interference assessed among patients using the Defense veterans pain rating scale 2.0	The Defense and Veterans Pain Rating Scale 2.0 utilizes a numerical rating scale enhanced by functional word descriptors, color coding, and pictorial facial expressions matched to pain levels. Four supplemental questions measure how much pain: a) interferes with usual activity, b) interferes with sleep, c) affects mood and d) contributes to stress. The scale for each assessment ranges from 0-10. Three assessments will occur each day. The daily average values will be compared at each time point. Higher Scores represent worse outcomes.	Each day from Postoperative Day 0 to Day 5.
Heart Rate Variability among Patients as assessed using time and frequency domain analysis of the heart rate.	Heart rate variability represents the change in the time interval in milliseconds between successive heartbeats. It is a measure of input to the heart from both sympathetic and parasympathetic branches of the nervous system. Increased heart rate variability is the better outcome.	Each day (over 8-hour periods, 7pm and 7am) from 5 days before surgery to postoperative day 5.
Implementation of Treatment among Patients as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures.	The Acceptability of Intervention measure, Appropriateness of Intervention measure, and Feasibility of Intervention Measure will be used. Each of these three tools is a 4-item questionnaire that has been validated as a distinct and strong measure of implementation success. Scale values for each measure range from 1-5. The average of the three measures will be computed and compared at each time point. Higher scores represent better outcomes.	Measurement will be at three points: within the 5 day period before surgery; on the day of Surgery; and on postoperative day 5.
Fidelity of Treatment among Patients as assessed by a Fidelity Checklist	Fidelity, the degree to which an intervention was implemented as it was intended by the developers, will be measured using a fidelity instrument with three domains: adherence (adherence to each component of treatment, scale 1- 5), participant responsiveness (measured on the treatment expectation questionnaire scale 0-10), and dosage (scale 1-5). Higher scores are better. We will compare the average scores overall, and in each domain.	Each day from Postoperative Day 0 to Day 5.
Implementation of Treatment among Providers as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures.	The Acceptability of Intervention measure, Appropriateness of Intervention measure, and Feasibility of Intervention Measure will be used. Each of these three tools is a 4-item questionnaire that has been validated as a distinct and strong measure of implementation success. Scale values for each measure range from 1-5. The average of the three measures will be computed and compared. Higher scores represent better outcomes.	On the day of surgery or within 1-day after.
Fidelity of Treatment among Providers as assessed by a Fidelity Checklist	Fidelity, the degree to which an intervention was implemented as it was intended by the developers, will be measured using a fidelity instrument with two domains: adherence (adherence to each component of treatment, scale 1- 5), and participant responsiveness (measured on the treatment expectation questionnaire scale 0-10). Higher scores are better. We will compare the average scores overall, and in each domain.	On the day of surgery or within 1-day after.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Opioid medication received by patients assessed in average daily oral morphine equivalents.	The amount of opioid analgesic medications received by patients as recorded in the electronic health record (inpatient setting) or as reported by patients (outpatient setting) will be summarized each day and reported in daily oral morphine equivalents. The total amount from postoperative day 0 to day 5, and the average daily oral morphine equivalents will be measured for comparisons. Higher amounts represent worse outcomes.	Each day from Postoperative Day 0 to Day 5.
Quality of Recovery among patients as measured using the Quality-of-Recovery 40 tool.	The Quality-of-Recovery 40 tool is a 40-item questionnaire, with each question graded on a five-point Likert scale. Scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). Assessment will occur preoperatively on the day of surgery (baseline value) and each day from Postoperative Day 0 to 5. The difference between the baseline and the value each day will be compared.	Preoperative on the day of surgery, and each day from Postoperative Day 0 to Day 5.

Collaborators and Investigators

• Sponsor: Durham VA Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Perioperative Care; Complementary Integrative Health (CIH); NSS2-Bridge; Battlefield Acupuncture (BFA)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 01968

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No