Feasibility of Bridge for Post-Operative Pain Management in Hip Arthroplasty
NCT ID: NCT05017701
Last Updated: 2025-10-21
Study Results
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View full resultsBasic Information
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TERMINATED
5 participants
INTERVENTIONAL
2022-04-26
2023-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Bridge device
The active Bridge device delivers electrical stimulation to the cranial and occipital nerves.
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 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
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.
Interventions
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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 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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Masimo Corporation
INDUSTRY
Responsible Party
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Locations
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CHEL0001
Identifier Type: -
Identifier Source: org_study_id
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