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| Name | Class |
|---|---|
| Masimo Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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.) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-Operative Day 1 |
| Self-Reported Pain Scores POD 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven L Orebaugh, MD | University of Pittsburgh | Principal Investigator |
| Amy Monroe, MPH, MBA | University of Pittsburgh | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Outpatient Center | West Mifflin | Pennsylvania | 15236 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Historical Controls | Historical Controls (n=27) who previously had arthroscopic ambulatory rotator cuff surgery, all other factors are the same as the intervention group (multimodal analgesia) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline population included BRIDGE participants (n = 15) and historical controls (n = 27), for a total of N = 42. Historical controls were identified retrospectively from medical records. Race and ethnicity data were not available for historical controls; therefore, these variables are reported as "Unknown" below.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oral Opioid Use POD 1 | This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records. | Posted | Mean | Standard Deviation | mg OME | Post-Operative Day 1 |
|
1-week
Adverse events are reported separately for each arm. BRIDGE participants (n=15) were assessed prospectively during the 1-week postoperative period. Historical Controls (n=27) were identified retrospectively, and adverse events were abstracted from available medical records. For outcomes where Historical Controls data were not available, zero Historical Controls participants were analyzed for those outcomes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Product Issues | Non-systematic Assessment | Skin irritation related to the device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Orebaugh, MD | University of Pittsburgh, UPMC | 412-650-2965 | orebaughsl@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2023 | Sep 17, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012421 | Rupture |
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|
|
Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.
| 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | Post-Operative Day 7 |
| BG001 | Historical Controls | 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.) |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity pertaining to historical control group (n=27) unavailable from retrospective medical records review. As a result, ethnicity is reported as "Unknown or Not Reported" below. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race pertaining to historical control group (n=27) unavailable from retrospective medical records review. As a result, race is reported as "Unknown or Not Reported" below. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
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.) |
|
|
| Primary | Oral Opioid Use POD 3 | This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records. | Posted | Mean | Standard Deviation | mg OME | Post-Operative Day 3 |
|
|
|
| Primary | Oral Opioid Use POD 5 | This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records. | Historical Controls data for this outcome were unavailable, and this measure was collected only in the BRIDGE group. Therefore, zero Historical Controls participants were analyzed. | Posted | Mean | Standard Deviation | mg OME | Post-Operative Day 5 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Post-Operative Day 1 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Post-Operative Day 3 |
|
|
|
| Secondary | 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. | Historical Controls data for this outcome were unavailable, and this measure was collected only in the BRIDGE group. Therefore, zero Historical Controls participants were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Post-Operative Day 5 |
|
|
|
| Secondary | 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 | Historical Controls data for this outcome were unavailable, and this measure was collected only in the BRIDGE group. Therefore, zero Historical Controls participants were analyzed. | Posted | Count of Participants | Participants | Post-Operative Day 5 |
|
|
|
| Secondary | 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 | Historical Controls data for this outcome were unavailable, and this measure was collected only in the BRIDGE group. Therefore, zero Historical Controls participants were analyzed. | Posted | Count of Participants | Participants | Post-Operative Day 7 |
|
|
|
| Secondary | Adverse Events Related to Opioid POD 5 | Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching | Historical Controls data for this outcome were unavailable, and this measure was collected only in the BRIDGE group. Therefore, zero Historical Controls participants were analyzed. | Posted | Count of Participants | Participants | Post-Operative Day 5 |
|
|
|
| Secondary | Adverse Events Related to Opioid POD 7 | Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching | Historical Controls data for this outcome were unavailable, and this measure was collected only in the BRIDGE group. Therefore, zero Historical Controls participants were analyzed. | Posted | Count of Participants | Participants | Post-Operative Day 7 |
|
|
|
| Secondary | 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 | Historical Controls data for this outcome were unavailable, and this measure was collected only in the BRIDGE group. Therefore, zero Historical Controls participants were analyzed. | Posted | Count of Participants | Participants | Post-operative Day 1 |
|
|
|
| Secondary | 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 | Historical Controls data for this outcome were unavailable, and this measure was collected only in the BRIDGE group. Therefore, zero Historical Controls participants were analyzed. | Posted | Count of Participants | Participants | Post-operative Day 3 |
|
|
|
| Secondary | 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 | Historical Controls data for this outcome were unavailable, and this measure was collected only in the BRIDGE group. Therefore, zero Historical Controls participants were analyzed. | Posted | Count of Participants | Participants | Post-operative Day 5 |
|
|
|
| Secondary | 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 | Historical Controls data for this outcome were unavailable, and this measure was collected only in the BRIDGE group. Therefore, zero Historical Controls participants were analyzed. | Posted | Count of Participants | Participants | Post-operative Day 7 |
|
|
|
| Primary | Oral Opioid Use POD 7 | This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records. | Historical Controls data for this outcome were unavailable, and this measure was collected only in the BRIDGE group. Therefore, zero Historical Controls participants were analyzed. | Posted | Mean | Standard Deviation | mg OME | Post-Operative Day 7 |
|
|
|
| Secondary | 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. | Historical Controls data for this outcome were unavailable, and this measure was collected only in the BRIDGE group. Therefore, zero Historical Controls participants were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Post-Operative Day 7 |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 3 |
| 15 |
| EG001 | Historical Controls | 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.) | 0 | 27 | 0 | 27 | 5 | 27 |
|
| Continuous electrical stimulation from device | Product Issues | Non-systematic Assessment |
|
| Headache | Surgical and medical procedures | Non-systematic Assessment |
|
| Nausea | Surgical and medical procedures | Non-systematic Assessment |
|
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| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |