Trial Outcomes & Findings for Bridge Device for Surgical Pain for Rotator Cuff Surgery (NCT NCT06071884)
NCT ID: NCT06071884
Last Updated: 2026-01-14
Results Overview
This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Post-Operative Day 7
Results posted on
2026-01-14
Participant Flow
Participant milestones
| Measure |
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.
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
27
|
|
Overall Study
COMPLETED
|
15
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Bridge Percutaneous Nerve Field Stimulator
n=15 Participants
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.
|
Historical Controls
n=27 Participants
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.)
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Age, Continuous
|
58.3 Years
STANDARD_DEVIATION 6.4 • n=14 Participants
|
56.2 Years
STANDARD_DEVIATION 7.8 • n=10 Participants
|
57.25 Years
STANDARD_DEVIATION 1.5 • n=24 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=14 Participants
|
12 Participants
n=10 Participants
|
18 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=14 Participants
|
15 Participants
n=10 Participants
|
24 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=14 Participants • 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.
|
0 Participants
n=10 Participants • 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.
|
1 Participants
n=24 Participants • 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.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=14 Participants • 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.
|
0 Participants
n=10 Participants • 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.
|
14 Participants
n=24 Participants • 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.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants • 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.
|
27 Participants
n=10 Participants • 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.
|
27 Participants
n=24 Participants • 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.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
14 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
27 Participants
n=10 Participants
|
27 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=14 Participants
|
27 participants
n=10 Participants
|
42 participants
n=24 Participants
|
|
Body Mass Index (BMI)
|
30.5 kg/m2
STANDARD_DEVIATION 8.1 • n=14 Participants
|
32.3 kg/m2
STANDARD_DEVIATION 7.8 • n=10 Participants
|
31.4 kg/m2
STANDARD_DEVIATION 1.3 • n=24 Participants
|
PRIMARY outcome
Timeframe: Post-Operative Day 1This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Outcome measures
| Measure |
Historical Controls
n=27 Participants
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.)
|
Bridge Percutaneous Nerve Field Stimulator
n=15 Participants
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.
|
|---|---|---|
|
Oral Opioid Use POD 1
|
40.2 mg OME
Standard Deviation 28.5
|
35.7 mg OME
Standard Deviation 37.1
|
PRIMARY outcome
Timeframe: Post-Operative Day 3This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Outcome measures
| Measure |
Historical Controls
n=27 Participants
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.)
|
Bridge Percutaneous Nerve Field Stimulator
n=15 Participants
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.
|
|---|---|---|
|
Oral Opioid Use POD 3
|
35.4 mg OME
Standard Deviation 25.7
|
21.5 mg OME
Standard Deviation 20.9
|
PRIMARY outcome
Timeframe: Post-Operative Day 5Population: 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.
This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Outcome measures
| Measure |
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.)
|
Bridge Percutaneous Nerve Field Stimulator
n=15 Participants
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.
|
|---|---|---|
|
Oral Opioid Use POD 5
|
—
|
6.0 mg OME
Standard Deviation 17.2
|
PRIMARY outcome
Timeframe: Post-Operative Day 7Population: 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.
This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Outcome measures
| Measure |
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.)
|
Bridge Percutaneous Nerve Field Stimulator
n=15 Participants
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.
|
|---|---|---|
|
Oral Opioid Use POD 7
|
—
|
0.5 mg OME
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: Post-Operative Day 1Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.
Outcome measures
| Measure |
Historical Controls
n=27 Participants
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.)
|
Bridge Percutaneous Nerve Field Stimulator
n=15 Participants
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.
|
|---|---|---|
|
Self-Reported Pain Scores POD 1
|
6.42 score on a scale
Standard Deviation 2.58
|
4.57 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Post-Operative Day 3Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.
Outcome measures
| Measure |
Historical Controls
n=27 Participants
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.)
|
Bridge Percutaneous Nerve Field Stimulator
n=15 Participants
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.
|
|---|---|---|
|
Self-Reported Pain Scores POD 3
|
6.75 score on a scale
Standard Deviation 2.01
|
3.18 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Post-Operative Day 5Population: 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.
Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.
Outcome measures
| Measure |
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.)
|
Bridge Percutaneous Nerve Field Stimulator
n=15 Participants
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.
|
|---|---|---|
|
Self-Reported Pain Scores POD 5
|
—
|
2.42 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Post-Operative Day 5Population: 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.
Collected through the subject diary (response yes/no) and recorded as a count of participants
Outcome measures
| Measure |
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.)
|
Bridge Percutaneous Nerve Field Stimulator
n=15 Participants
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.
|
|---|---|---|
|
Number of Participants Who Self-Reported Oral Opioid Use POD 5
Responded 'No'
|
—
|
8 Participants
|
|
Number of Participants Who Self-Reported Oral Opioid Use POD 5
Responded 'Yes'
|
—
|
7 Participants
|
SECONDARY outcome
Timeframe: Post-Operative Day 7Population: 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.
Collected through the subject diary (response yes/no) and recorded as a count of participants
Outcome measures
| Measure |
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.)
|
Bridge Percutaneous Nerve Field Stimulator
n=15 Participants
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.
|
|---|---|---|
|
Number of Participants Who Self-Reported Oral Opioid Use POD 7
Responded 'Yes'
|
—
|
3 Participants
|
|
Number of Participants Who Self-Reported Oral Opioid Use POD 7
Responded 'No'
|
—
|
12 Participants
|
SECONDARY outcome
Timeframe: Post-Operative Day 5Population: 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.
Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching
Outcome measures
| Measure |
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.)
|
Bridge Percutaneous Nerve Field Stimulator
n=15 Participants
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.
|
|---|---|---|
|
Adverse Events Related to Opioid POD 5
Responded 'Yes'
|
—
|
0 Participants
|
|
Adverse Events Related to Opioid POD 5
Responded 'No'
|
—
|
15 Participants
|
SECONDARY outcome
Timeframe: Post-Operative Day 7Population: 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.
Recorded as yes/no for adverse events related to opioids like nausea, vomiting, dizziness, and itching
Outcome measures
| Measure |
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.)
|
Bridge Percutaneous Nerve Field Stimulator
n=15 Participants
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.
|
|---|---|---|
|
Adverse Events Related to Opioid POD 7
Responded 'Yes'
|
—
|
3 Participants
|
|
Adverse Events Related to Opioid POD 7
Responded 'No'
|
—
|
12 Participants
|
SECONDARY outcome
Timeframe: Post-operative Day 1Population: 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.
Recorded as yes/no for adverse events related to the device such as pain or skin irritation
Outcome measures
| Measure |
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.)
|
Bridge Percutaneous Nerve Field Stimulator
n=15 Participants
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.
|
|---|---|---|
|
Local Adverse Events on Ear Related to Device POD 1
Responded 'Yes'
|
—
|
0 Participants
|
|
Local Adverse Events on Ear Related to Device POD 1
Responded 'No'
|
—
|
15 Participants
|
SECONDARY outcome
Timeframe: Post-operative Day 3Population: 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.
Recorded as yes/no for adverse events related to the device such as pain or skin irritation
Outcome measures
| Measure |
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.)
|
Bridge Percutaneous Nerve Field Stimulator
n=15 Participants
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.
|
|---|---|---|
|
Local Adverse Events on Ear Related to Device POD 3
Responded 'Yes'
|
—
|
0 Participants
|
|
Local Adverse Events on Ear Related to Device POD 3
Responded 'No'
|
—
|
15 Participants
|
SECONDARY outcome
Timeframe: Post-operative Day 5Population: 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.
Recorded as yes/no for adverse events related to the device such as pain or skin irritation
Outcome measures
| Measure |
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.)
|
Bridge Percutaneous Nerve Field Stimulator
n=15 Participants
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.
|
|---|---|---|
|
Local Adverse Events on Ear Related to Device POD 5
Responded 'Yes'
|
—
|
0 Participants
|
|
Local Adverse Events on Ear Related to Device POD 5
Responded 'No'
|
—
|
15 Participants
|
SECONDARY outcome
Timeframe: Post-operative Day 7Population: 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.
Recorded as yes/no for adverse events related to the device such as pain or skin irritation
Outcome measures
| Measure |
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.)
|
Bridge Percutaneous Nerve Field Stimulator
n=15 Participants
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.
|
|---|---|---|
|
Local Adverse Events on Ear Related to Device POD 7
Responded 'Yes'
|
—
|
3 Participants
|
|
Local Adverse Events on Ear Related to Device POD 7
Responded 'No'
|
—
|
12 Participants
|
SECONDARY outcome
Timeframe: Post-Operative Day 7Population: 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.
Pain scores will be completed on a Numeric Rating Scale (NRS) of 0=no pain at all and 10=the most severe pain.
Outcome measures
| Measure |
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.)
|
Bridge Percutaneous Nerve Field Stimulator
n=15 Participants
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.
|
|---|---|---|
|
Self-Reported Pain Scores POD 7
|
—
|
1.8 score on a scale
Standard Deviation 1.82
|
Adverse Events
Bridge Percutaneous Nerve Field Stimulator
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Historical Controls
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bridge Percutaneous Nerve Field Stimulator
n=15 participants at risk
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.
|
Historical Controls
n=27 participants at risk
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.)
|
|---|---|---|
|
Product Issues
Skin irritation
|
13.3%
2/15 • Number of events 2 • 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.
|
0.00%
0/27 • 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.
|
|
Product Issues
Continuous electrical stimulation from device
|
6.7%
1/15 • Number of events 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.
|
0.00%
0/27 • 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.
|
|
Surgical and medical procedures
Headache
|
0.00%
0/15 • 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.
|
7.4%
2/27 • Number of events 2 • 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.
|
|
Surgical and medical procedures
Nausea
|
20.0%
3/15 • Number of events 3 • 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.
|
11.1%
3/27 • Number of events 3 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place