Bridge Device for Surgical Pain for Rotator Cuff Surgery

NCT06071884 | Completed Results FDA Device

• 1 other identifier: STUDY23030139
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the trial is to investigate the efficacy of the Bridge device in reducing post-operative pain and post-operative opioid consumption in patients undergoing rotator cuff surgery with the typical mode of anesthesia, nerve block plus propofol sedation.

Conditions

Pain; Rotator Cuff Injuries

Outcome Measures

Primary Outcomes (4)

• Oral Opioid Use POD 1

  This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.

  Post-Operative Day 1

• Oral Opioid Use POD 3

  This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.

  Post-Operative Day 3

• Oral Opioid Use POD 5

  This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.

  Post-Operative Day 5

• Oral Opioid Use POD 7

  This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.

  Post-Operative Day 7

Secondary Outcomes (12)

• Self-Reported Pain Scores POD 1

  Post-Operative Day 1

• Self-Reported Pain Scores POD 3

  Post-Operative Day 3

• Self-Reported Pain Scores POD 5

  Post-Operative Day 5

• Number of Participants Who Self-Reported Oral Opioid Use POD 5

  Post-Operative Day 5

• Number of Participants Who Self-Reported Oral Opioid Use POD 7

  Post-Operative Day 7

Study Arms (2)

Bridge Percutaneous Nerve Field Stimulator

EXPERIMENTAL

The case group (n = 15) will receive an activated Bridge device after surgery and continuing wearing the device until post-operative day (POD) 7.

Device: Bridge Percutaneous Nerve Field Stimulator

Historical Control

NO INTERVENTION

Historical Controls (n=27) who previously had arthroscopic ambulatory rotator cuff surgery, all other factors are the same as the intervention group (multimodal analgesia, etc.)

Interventions

Bridge Percutaneous Nerve Field Stimulator DEVICE

The Bridge device is an FDA-cleared, drug-free, non-surgical device that uses neuro-modulation to aid in the reduction of symptoms associated with opioid withdrawal through application to branches of the Cranial Nerves V, VII, IX, X, and the occipital nerves. This study is investigating its effectiveness treating post-surgical pain.

Also known as: NSS-2 BRIDGE

Bridge Percutaneous Nerve Field Stimulator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than 18 years of age
• Willing and able to provide informed consent
• Scheduled to undergo elective rotator cuff surgery at UPMC
• No pre-existing medical conditions which would prevent application of the Bridge device on auricle of ear (i.e., skin infection, rash)

You may not qualify if:

• Opioids dependence
• Chronic pain condition with daily opioid use
• Anatomical malformation, which may interfere with placement of the nerve block
• Raynaud's disease diagnosis
• Vasculopathy
• Hemophilia or other coagulopathy, or use of active anticoagulation other than aspirin
• Patient refusal
• Pacemaker
• Pre-existing medical conditions which would prevent application of the Bridge device on auricle of ear (i.e., skin infection, rash)
• Psoriasis vulgaris

Sponsors & Collaborators

• Steven Orebaugh: lead
• Masimo Corporation: collaborator

Study Sites (1)

UPMC Outpatient Center

West Mifflin, Pennsylvania, 15236, United States

Location

MeSH Terms

Conditions

Pain; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Results Point of Contact

• Title: Steven Orebaugh, MD
• Organization: University of Pittsburgh, UPMC

orebaughsl@upmc.edu

412-650-2965

Study Officials

• Steven L Orebaugh, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Amy Monroe, MPH, MBA

  University of Pittsburgh

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: October 10, 2023
• Study Start: July 29, 2024
• Primary Completion: September 26, 2024
• Study Completion: September 26, 2024
• Last Updated: January 14, 2026
• Results First Posted: January 14, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)