Pain, Rotator Cuff Injuries
Conditions
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.
Interventions
DEVICEBridge 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.
Sponsors
Masimo Corporation
Steven Orebaugh
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral Opioid Use POD 1 | 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 | 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 | 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 | Post-Operative Day 7 | This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Self-Reported Oral Opioid Use POD 7 | Post-Operative Day 7 | Collected through the subject diary (response yes/no) and recorded as a count of participants |
| Adverse Events Related to Opioid POD 5 | Post-Operative Day 5 | Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching |
| Adverse Events Related to Opioid POD 7 | Post-Operative Day 7 | Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching |
| Local Adverse Events on Ear Related to Device POD 1 | Post-operative Day 1 | Recorded as yes/no for adverse events related to the device such as pain or skin irritation |
| Self-Reported Pain Scores POD 1 | Post-Operative Day 1 | Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain. |
| Local Adverse Events on Ear Related to Device POD 5 | Post-operative Day 5 | Recorded as yes/no for adverse events related to the device such as pain or skin irritation |
| Local Adverse Events on Ear Related to Device POD 7 | Post-operative Day 7 | Recorded as yes/no for adverse events related to the device such as pain or skin irritation |
| Self-Reported Pain Scores POD 7 | Post-Operative Day 7 | Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain. |
| Local Adverse Events on Ear Related to Device POD 3 | Post-operative Day 3 | Recorded as yes/no for adverse events related to the device such as pain or skin irritation |
| Self-Reported Pain Scores POD 3 | Post-Operative Day 3 | Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain. |
| Self-Reported Pain Scores POD 5 | Post-Operative Day 5 | Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain. |
| Number of Participants Who Self-Reported Oral Opioid Use POD 5 | Post-Operative Day 5 | Collected through the subject diary (response yes/no) and recorded as a count of participants |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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.) | 27 |
| Total | 42 |
Baseline characteristics
| Characteristic | Bridge Percutaneous Nerve Field Stimulator | Historical Controls | Total |
|---|---|---|---|
| Age, Continuous | 58.3 Years STANDARD_DEVIATION 6.4 | 56.2 Years STANDARD_DEVIATION 7.8 | 57.25 Years STANDARD_DEVIATION 1.5 |
| Body Mass Index (BMI) | 30.5 kg/m2 STANDARD_DEVIATION 8.1 | 32.3 kg/m2 STANDARD_DEVIATION 7.8 | 31.4 kg/m2 STANDARD_DEVIATION 1.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 0 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 27 Participants | 27 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 27 Participants | 27 Participants |
| Race (NIH/OMB) White | 14 Participants | 0 Participants | 14 Participants |
| Region of Enrollment United States | 15 participants | 27 participants | 42 participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 18 Participants |
| Sex: Female, Male Male | 9 Participants | 15 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 27 |
| other Total, other adverse events | 3 / 15 | 5 / 27 |
| serious Total, serious adverse events | 0 / 15 | 0 / 27 |
Outcome results
Primary
Oral Opioid Use POD 1
This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Time frame: Post-Operative Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bridge Percutaneous Nerve Field Stimulator | Oral Opioid Use POD 1 | 35.7 mg OME | Standard Deviation 37.1 |
| Historical Controls | Oral Opioid Use POD 1 | 40.2 mg OME | Standard Deviation 28.5 |
Primary
Oral Opioid Use POD 3
This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Time frame: Post-Operative Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bridge Percutaneous Nerve Field Stimulator | Oral Opioid Use POD 3 | 21.5 mg OME | Standard Deviation 20.9 |
| Historical Controls | Oral Opioid Use POD 3 | 35.4 mg OME | Standard Deviation 25.7 |
Primary
Oral Opioid Use POD 5
This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Time frame: Post-Operative Day 5
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bridge Percutaneous Nerve Field Stimulator | Oral Opioid Use POD 5 | 6.0 mg OME | Standard Deviation 17.2 |
Primary
Oral Opioid Use POD 7
This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Time frame: Post-Operative Day 7
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bridge Percutaneous Nerve Field Stimulator | Oral Opioid Use POD 7 | 0.5 mg OME | Standard Deviation 1.94 |
Secondary
Adverse Events Related to Opioid POD 5
Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching
Time frame: Post-Operative Day 5
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bridge Percutaneous Nerve Field Stimulator | Adverse Events Related to Opioid POD 5 | Responded 'Yes' | 0 Participants |
| Bridge Percutaneous Nerve Field Stimulator | Adverse Events Related to Opioid POD 5 | Responded 'No' | 15 Participants |
Secondary
Adverse Events Related to Opioid POD 7
Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching
Time frame: Post-Operative Day 7
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bridge Percutaneous Nerve Field Stimulator | Adverse Events Related to Opioid POD 7 | Responded 'Yes' | 3 Participants |
| Bridge Percutaneous Nerve Field Stimulator | Adverse Events Related to Opioid POD 7 | Responded 'No' | 12 Participants |
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
Time frame: Post-operative Day 1
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bridge Percutaneous Nerve Field Stimulator | Local Adverse Events on Ear Related to Device POD 1 | Responded 'Yes' | 0 Participants |
| Bridge Percutaneous Nerve Field Stimulator | Local Adverse Events on Ear Related to Device POD 1 | Responded 'No' | 15 Participants |
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
Time frame: Post-operative Day 3
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bridge Percutaneous Nerve Field Stimulator | Local Adverse Events on Ear Related to Device POD 3 | Responded 'Yes' | 0 Participants |
| Bridge Percutaneous Nerve Field Stimulator | Local Adverse Events on Ear Related to Device POD 3 | Responded 'No' | 15 Participants |
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
Time frame: Post-operative Day 5
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bridge Percutaneous Nerve Field Stimulator | Local Adverse Events on Ear Related to Device POD 5 | Responded 'Yes' | 0 Participants |
| Bridge Percutaneous Nerve Field Stimulator | Local Adverse Events on Ear Related to Device POD 5 | Responded 'No' | 15 Participants |
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
Time frame: Post-operative Day 7
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bridge Percutaneous Nerve Field Stimulator | Local Adverse Events on Ear Related to Device POD 7 | Responded 'Yes' | 3 Participants |
| Bridge Percutaneous Nerve Field Stimulator | Local Adverse Events on Ear Related to Device POD 7 | Responded 'No' | 12 Participants |
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
Time frame: Post-Operative Day 5
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bridge Percutaneous Nerve Field Stimulator | Number of Participants Who Self-Reported Oral Opioid Use POD 5 | Responded 'Yes' | 7 Participants |
| Bridge Percutaneous Nerve Field Stimulator | Number of Participants Who Self-Reported Oral Opioid Use POD 5 | Responded 'No' | 8 Participants |
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
Time frame: Post-Operative Day 7
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bridge Percutaneous Nerve Field Stimulator | Number of Participants Who Self-Reported Oral Opioid Use POD 7 | Responded 'Yes' | 3 Participants |
| Bridge Percutaneous Nerve Field Stimulator | Number of Participants Who Self-Reported Oral Opioid Use POD 7 | Responded 'No' | 12 Participants |
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.
Time frame: Post-Operative Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bridge Percutaneous Nerve Field Stimulator | Self-Reported Pain Scores POD 1 | 4.57 score on a scale | Standard Deviation 2.9 |
| Historical Controls | Self-Reported Pain Scores POD 1 | 6.42 score on a scale | Standard Deviation 2.58 |
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.
Time frame: Post-Operative Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bridge Percutaneous Nerve Field Stimulator | Self-Reported Pain Scores POD 3 | 3.18 score on a scale | Standard Deviation 2.2 |
| Historical Controls | Self-Reported Pain Scores POD 3 | 6.75 score on a scale | Standard Deviation 2.01 |
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.
Time frame: Post-Operative Day 5
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bridge Percutaneous Nerve Field Stimulator | Self-Reported Pain Scores POD 5 | 2.42 score on a scale | Standard Deviation 2.1 |
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.
Time frame: Post-Operative Day 7
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bridge Percutaneous Nerve Field Stimulator | Self-Reported Pain Scores POD 7 | 1.8 score on a scale | Standard Deviation 1.82 |