Bridge Device for Surgical Pain for Rotator Cuff Surgery

NCT ID: NCT06071884

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-29
• Study Completion Date: 2024-09-26

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.

Detailed Description

The interscalene block is the gold standard for postoperative pain management following rotator cuff surgery. However, the duration of the block does not cover rehabilitation. Therefore, in most cases, patients are discharged from the surgical center with an opioid prescription. There is a growing need to investigate complementary, non-pharmacologic pain-management methods. The Bridge device, which provides auricular neuromodulation of various cutaneous nerves near the ear, is manufactured by Masimo and previously FDA-approved to reduce symptoms of opioid withdrawal. It is a promising technology that could help relieve post-operative pain without exposing patients to the adverse effects of opioids or other pain-relieving medications. 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. Those enrolled will be assigned to a study group and compared to historic cohort (control group). Historic control group involves patients that underwent same surgical procedure performed at the surgical center involved in the study, by the same surgical operator, between 2020 and 2023.

*Prior to study enrollment, the outcome measure timepoints were updated to postoperative days (POD) 1, 3, 5, and 7. This was largely due to pain trajectories in surgical populations often follow a predictable, nonlinear course, with meaningful fluctuations most apparent on alternating days rather than daily increments. By assessing the outcome measures on POD 1, 3, 5, and 7, the revised scheduled timepoints continues to capture initial peak (POD 1), early recovery phase (POD3), the late recovery phase (POD 5), and the resolution/transition phase (POD 7) regarding pain trajectories.

Conditions

Pain; Rotator Cuff Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bridge Percutaneous Nerve Field Stimulator

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

Group Type: EXPERIMENTAL

Bridge Percutaneous Nerve Field Stimulator

Intervention Type: 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.

Historical Control

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.)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bridge Percutaneous Nerve Field Stimulator

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.

Intervention Type: DEVICE

Other Intervention Names

NSS-2 BRIDGE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masimo Corporation

INDUSTRY

Sponsor Role: collaborator

Steven Orebaugh

OTHER

Sponsor Role: lead

Responsible Party

Steven Orebaugh

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Steven L Orebaugh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Amy Monroe, MPH, MBA

Role: STUDY_DIRECTOR

University of Pittsburgh

Locations

UPMC Outpatient Center

West Mifflin, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY23030139

Identifier Type: -

Identifier Source: org_study_id