PainNCT06071884
Bridge Device for Surgical Pain for Rotator Cuff Surgery
A study testing Bridge Percutaneous Nerve Field Stimulator in people with Pain and Rotator Cuff Injuries, run by Steven Orebaugh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Rotator Cuff Injuries
- What is being tested?
- Bridge Percutaneous Nerve Field Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2024to 26 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Outpatient Center
West Mifflin, Pennsylvania, 15236
About this study
Official title: Evaluation of Bridge Device in Pain Management for Outpatient Rotator Cuff Surgery
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.
Read the 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
- Being tested
- Bridge Percutaneous Nerve Field Stimulator
- Medical subject headings
- Pain, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bridge Percutaneous Nerve Field StimulatorDevice
Also called NSS-2 BRIDGE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Opioid Use POD 1
This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-Operative Day 7
Secondary outcomes (12)
Self-Reported Pain Scores POD 1
Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.
Measured: Post-Operative Day 1
Self-Reported Pain Scores POD 3
Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.
Measured: Post-Operative Day 3
Self-Reported Pain Scores POD 5
Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.
Measured: Post-Operative Day 5
Number of Participants Who Self-Reported Oral Opioid Use POD 5
Collected through the subject diary (response yes/no) and recorded as a count of participants
Measured: Post-Operative Day 5
Number of Participants Who Self-Reported Oral Opioid Use POD 7
Collected through the subject diary (response yes/no) and recorded as a count of participants
Measured: Post-Operative Day 7
Adverse Events Related to Opioid POD 5
Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching
Measured: Post-Operative Day 5
Adverse Events Related to Opioid POD 7
Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching
Measured: Post-Operative Day 7
Local Adverse Events on Ear Related to Device POD 1
Recorded as yes/no for adverse events related to the device such as pain or skin irritation
Measured: Post-operative Day 1
Local Adverse Events on Ear Related to Device POD 3
Recorded as yes/no for adverse events related to the device such as pain or skin irritation
Measured: Post-operative Day 3
Local Adverse Events on Ear Related to Device POD 5
Recorded as yes/no for adverse events related to the device such as pain or skin irritation
Measured: Post-operative Day 5
Local Adverse Events on Ear Related to Device POD 7
Recorded as yes/no for adverse events related to the device such as pain or skin irritation
Measured: Post-operative Day 7
Self-Reported Pain Scores POD 7
Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.
Measured: Post-Operative Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start29 Jul 2024
- Primary completion26 Sep 2024
- Study completion26 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven Orebaugh
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Corporation
- Responsible party
- Sponsor-investigator, Steven Orebaugh, University of Pittsburgh
- Investigators
- Steven L Orebaugh, MD, Principal investigator, University of PittsburghAmy Monroe, MPH, MBA, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071884
- Sponsor's protocol ID
- STUDY23030139
- Status last verified
- Aug 2024
- First submitted
- 24 Sep 2023
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bridge Device in Pain Management for Outpatient Rotator Cuff Surgery
- ClinicalTrials.gov ID
- NCT06071884
- Acronym / sponsor ID
- STUDY23030139
- Conditions
- Pain, Rotator Cuff Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Steven OrebaughUniversity, hospital or other
- Collaborators
- Masimo Corporation
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Posted 14 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bridge Percutaneous Nerve Field Stimulator | Experimental | Device: Bridge Percutaneous Nerve Field StimulatorThe case group (n = 15) will receive an activated Bridge device after surgery and continuing wearing the device until post-operative day (POD) 7. |
| 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.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bridge Percutaneous Nerve Field StimulatorAlso: NSS-2 BRIDGEThe 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. | Device | Bridge Percutaneous Nerve Field Stimulator |
Primary outcome
Oral Opioid Use POD 1
Time frame: Post-Operative Day 1
This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Oral Opioid Use POD 3
Time frame: Post-Operative Day 3
This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Oral Opioid Use POD 5
Time frame: Post-Operative Day 5
This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Oral Opioid Use POD 7
Time frame: Post-Operative Day 7
This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
12 secondary outcomes
Self-Reported Pain Scores POD 1
Time frame: Post-Operative Day 1
Self-Reported Pain Scores POD 3
Time frame: Post-Operative Day 3
Self-Reported Pain Scores POD 5
Time frame: Post-Operative Day 5
Number of Participants Who Self-Reported Oral Opioid Use POD 5
Time frame: Post-Operative Day 5
Number of Participants Who Self-Reported Oral Opioid Use POD 7
Time frame: Post-Operative Day 7
Adverse Events Related to Opioid POD 5
Time frame: Post-Operative Day 5
Adverse Events Related to Opioid POD 7
Time frame: Post-Operative Day 7
Local Adverse Events on Ear Related to Device POD 1
Time frame: Post-operative Day 1
Local Adverse Events on Ear Related to Device POD 3
Time frame: Post-operative Day 3
Local Adverse Events on Ear Related to Device POD 5
Time frame: Post-operative Day 5
Local Adverse Events on Ear Related to Device POD 7
Time frame: Post-operative Day 7
Self-Reported Pain Scores POD 7
Time frame: Post-Operative Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven L Orebaugh, MD principal investigator
University of Pittsburgh
Amy Monroe, MPH, MBA study director
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bridge Percutaneous Nerve Field Stimulator in people with Pain and Rotator Cuff Injuries, run by Steven Orebaugh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Opioid Use POD 1 (time frame: Post-Operative Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.