Feasibility of Bridge for Post-Operative Pain Management in Hip Arthroplasty

The aim of this research study is to gather data regarding the feasibility of the Bridge system for the management of pain following total hip arthroplasty (THA).

Study Overview

• Status: Terminated
• Conditions: Pain, Postoperative
• Intervention / Treatment: Device: Bridge device; Device: Sham device

• Study Type: Interventional
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Subject is 18 years of age or older
• Subject scheduled for elective primary unilateral total hip arthroplasty (THA)
• Subject opioid use is less than 60 milligram morphine equivalent for the last 30 days
• Subject has given written informed consent to participate in the study

Exclusion Criteria:

• Subjects who are pregnant or breastfeeding
• Subjects with cardiac pacemakers or other implanted devices (e.g. vagal nerve simulators), hemophilia or psoriasis vulgaris
• Subjects with a history of active depression, anxiety or catastrophizing
• Subjects with active alcoholism or drug abuse
• Subjects with severe chronic pain condition that requires daily preoperative opioid dependence
• Subjects deemed not suitable for the study at the discretion of the principal investigator
• Subjects who are concurrently participating in any other research study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bridge device; The active Bridge device delivers electrical stimulation to the cranial and occipital nerves.	Device: Bridge device; Bridge is a percutaneous nerve field stimulation device which uses alternating currents of stimulation over a large field and with higher voltage in order to influence central pain areas.
Sham Comparator: Sham device; The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses	Device: Sham device; The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Opioid Consumption Between Active and Sham Arms.	The sample size is well below the threshold needed to reliably assess outcomes and perform statistical comparisons. As a result, we have provided the raw data for comparison of opioid consumption between the two groups.	Day of surgery to Day 5 (120 hours) post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale.	Pain scores using a numerical scale will be collected at rest and movement and will be obtained prior to surgery, in the recovery room, prior to leaving the recovery room, every 6 hours during the first 24 hrs, and at 48, 72, 96 and 120 hours post-operatively. Subjects will use a 0-10 numeric scale (0 indicating no pain and 10 indicating extreme pain).	Day of surgery to Day 5 (120 hours) post-op
Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale.	Postoperative nausea and vomiting will be evaluated from immediately after surgery through postoperative day 5, using a 0-10 scale (0 indicating no nausea and 10 indicating extreme nausea).	Day of surgery to Day 5 (120 hours) post-op
Change in Functional Recovery Between Active and Sham Arms Assessed Using the Timed Up and Go (TUG) Assessment Collected on Post-Op Day 30	Functional recovery will be assessed daily from day of surgery to post-op day 5, using the Timed Up and Go assessment to assess mobility.	Day of surgery to post-operative day 30.
Change in Functional Recovery Between Active and Sham Arms Assessed Using the 12-Item Short Form Survey (SF-12) Collected on Post-Op Day 30	Subjects will also complete the 12-Item Short Form Survey (SF-12) on Post-Op day 30 to evaluate quality of recovery.	Day of surgery to post-operative day 30.

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Actual): November 19, 2022
• Study Completion (Actual): May 24, 2023

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Estimated): October 21, 2025
• Last Update Submitted That Met QC Criteria: October 3, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: CHEL0001