Bridge Device for Surgical Pain After Rotator Cuff Injury

Overseen By Carly Riedmann, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Steven Orebaugh

Must not be taking: Opioids, Anticoagulants

Disqualifiers: Opioid dependence, Chronic pain, Raynaud's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 week

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using active anticoagulation other than aspirin, you may be excluded from the trial.

What data supports the idea that Bridge Device for Surgical Pain After Rotator Cuff Injury is an effective treatment?

The available research shows that the Bridge Device, which is a type of nerve stimulation treatment, has been effective in reducing pain and the need for opioids after surgeries like gastric bypass. It has also been used to help with symptoms of opioid withdrawal and chronic pain from surgical scars. Although there is no direct data on its use for rotator cuff surgery, these studies suggest it could be a promising option for managing surgical pain without relying on drugs. ^{1 2 3 4 5}

What safety data exists for the Bridge Device used for surgical pain after rotator cuff injury?

The Bridge Device, part of the Neuro-Stim System™ family, has been evaluated for safety in a retrospective cohort study. This study monitored 1,207 devices, resulting in 19,312 punctures, for adverse effects such as bleeding, localized dermatitis, infections at implantation sites, dermatitis at the generator site, and patient syncope. The procedure is considered minimal-risk and has been approved by multiple governmental and institutional facilities. Overall, the device has demonstrated a minimal adverse effects profile. ^{2 4 5 6 7}

Is the Bridge Device a promising treatment for surgical pain after rotator cuff injury?

Yes, the Bridge Device is a promising treatment for surgical pain after rotator cuff injury. It uses a non-drug method called neuromodulation to relieve pain, which means it helps control pain by sending electrical signals to nerves. This approach has been shown to be effective in reducing pain with minimal side effects, making it a safe option for managing pain after surgery. ^{2 4 5 8 9}

Research Team

Steven L Orebaugh, MD

Principal Investigator

University of Pittsburgh

Amy Monroe, MPH, MBA

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults over 18 scheduled for elective rotator cuff surgery at UPMC, who can consent and have no skin issues on the ear where the Bridge device will be placed. It's not for those dependent on opioids, with chronic pain and daily opioid use, certain blood disorders, pacemakers, or conditions like Raynaud's disease.

Inclusion Criteria

I am scheduled for rotator cuff surgery at UPMC.

Willing and able to provide informed consent

I am older than 18 years.

Exclusion Criteria

I have chosen not to participate in the trial.

I have a bleeding disorder or I'm on blood thinners other than aspirin.

Pacemaker

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the Bridge device after surgery and continue wearing it until post-operative day 7

1 week

1 visit (in-person) for surgery and device application

Follow-up

Participants are monitored for pain scores and opioid use from post-operative day 1 to day 7

1 week

Daily self-reported assessments

Long-term follow-up

Participants are monitored for any long-term adverse events related to the device or opioid use

4 weeks

Treatment Details

Interventions

• Bridge Percutaneous Nerve Field Stimulator

Trial Overview The study tests if the Bridge device can lessen post-surgery pain and reduce opioid use after rotator cuff surgery. Participants receive standard anesthesia plus this non-drug treatment that stimulates nerves through the skin of their ear.

Participant Groups

Group I: Bridge Percutaneous Nerve Field Stimulator Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Steven Orebaugh

Lead Sponsor

Trials

2

Recruited

70+

Masimo Corporation

Industry Sponsor

Trials

117

Recruited

13,500+

Katie Szyman

Masimo Corporation

Chief Executive Officer

BA from the University of St. Thomas, MBA from Harvard Business School

Dr. Bilal Muhsin

Masimo Corporation

Chief Medical Officer since 2024

MD from Harvard Medical School

Findings from Research

The BRIDGE® device significantly reduced opioid withdrawal scores in patients, with a 62.7% reduction at 20 minutes and a remarkable 97.1% reduction by day 5, indicating its efficacy as a non-pharmacological treatment.

In this pilot study of 73 adult patients, 88.8% successfully transitioned to medication-assisted therapy (MAT) after using the BRIDGE, suggesting it may facilitate smoother transitions during opioid withdrawal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation with percutaneous electrical nerve field stimulation is associated with reduction in signs and symptoms of opioid withdrawal: a multisite, retrospective assessment. Miranda, A., Taca, A.[2018]

This proof-of-concept study shows that percutaneous peripheral nerve stimulation (PNS) targeting the brachial plexus is feasible for managing pain after rotator cuff surgery, although it may not provide immediate analgesia as effectively as traditional nerve blocks.

While immediate pain relief was limited, the study found that PNS could help reduce opioid use in the days following surgery, suggesting potential benefits for long-term pain management, warranting further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided percutaneous peripheral nerve stimulation: neuromodulation of the suprascapular nerve and brachial plexus for postoperative analgesia following ambulatory rotator cuff repair. A proof-of-concept study. Ilfeld, BM., Finneran, JJ., Gabriel, RA., et al.[2021]

The NSS-2 BRIDGE device significantly reduced opioid consumption by 60.2% and pain levels by 28% in patients after gastric bypass surgery, indicating its potential effectiveness in pain management.

The device was well-tolerated by patients, with tolerability ratings considered excellent, suggesting it could be a viable alternative to traditional pain relief methods post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular nerve stimulation using the NSS-2 BRIDGE device to reduce opioid requirement following laparoscopic Roux-en-Y gastric bypass. Ahmed, BH., Courcoulas, AP., Monroe, AL., et al.[2022]

Peripheral nerve field stimulation (PNFS) effectively relieved post-thoracotomy scar pain in patients who did not respond to conventional pain management, indicating its potential as a treatment for chronic surgical-scar pain.

Choosing PNFS over spinal cord stimulation minimized the risk of complications and neurological issues, highlighting its safety as a peripheral approach to pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve field stimulation for intractable post-thoracotomy scar pain not relieved by conventional treatment. Goyal, GN., Gupta, D., Jain, R., et al.[2010]

The Neuro-Stim System™ devices, used for pain relief through a minimally invasive procedure, have been deemed low-risk by various regulatory bodies, indicating a favorable safety profile.

In a study monitoring 1,207 devices and over 19,000 punctures, the incidence of adverse effects such as bleeding, dermatitis, and infections was quantified, providing valuable data on the safety of this neuromodulation technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study. Roberts, A., Sithole, A., Sedghi, M., et al.[2020]

Spinal cord stimulators (SCS) and peripheral nerve stimulators (PNS) are effective treatments for chronic pain, enabling many military service members to return to work and daily activities.

Despite potential environmental and occupational hazards faced by military personnel, the risk of complications from SCS and PNS devices remains low, indicating their safety in these challenging conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Military concerns for chronic pain stimulator devices. Hughey, S., Field, R., Campbell, D., et al.[2023]

A shoulder elevation device was tested on 86 patients with thoracic outlet syndrome (TOS) and was particularly effective for those with distal symptoms, showing significant improvements in pain (67%), numbness (85%), and motor disturbances (80%).

The device works by counterbalancing downward traction on the brachial plexus, which helps relieve symptoms, although it was less effective for proximal symptoms, with only 65% of patients experiencing relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservative treatment of thoracic outlet syndrome using an orthosis. Nakatsuchi, Y., Saitoh, S., Hosaka, M., et al.[2019]

The posterior approach for spinal accessory nerve (SAN) to suprascapular nerve (SSN) transfer in 28 patients allowed for better visualization and treatment of SSN pathology, which was found in 40% of high-energy trauma cases, leading to improved outcomes.

This technique resulted in 75% of patients achieving a British Medical Research Council grade of 4 or higher for shoulder external rotation, with a median range of motion of 137.5°, indicating effective restoration of rotator cuff function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Clinical Outcomes of Spinal Accessory to Suprascapular Nerve Transfer Through a Posterior Approach. Jimulia, DT., Duraku, LS., Parekh, JN., et al.[2023]

A single case report demonstrated that percutaneous implantation of a stimulating electrode to the brachial plexus effectively managed intractable pain following a traction injury, resulting in excellent pain control and beneficial sensory and motor changes in the patient's arm.

This method is presented as a simpler and potentially more effective alternative to traditional surgical implantation for pain management in cases of brachial plexus injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous implantation of a brachial plexus electrode for management of pain syndrome caused by a traction injury. Goroszeniuk, T., Kothari, SC., Hamann, WC.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Neuromodulation with percutaneous electrical nerve field stimulation is associated with reduction in signs and symptoms of opioid withdrawal: a multisite, retrospective assessment. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Ultrasound-guided percutaneous peripheral nerve stimulation: neuromodulation of the suprascapular nerve and brachial plexus for postoperative analgesia following ambulatory rotator cuff repair. A proof-of-concept study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Auricular nerve stimulation using the NSS-2 BRIDGE device to reduce opioid requirement following laparoscopic Roux-en-Y gastric bypass. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Peripheral nerve field stimulation for intractable post-thoracotomy scar pain not relieved by conventional treatment. [2010]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Military concerns for chronic pain stimulator devices. [2023]

7. Scotland pubmed.ncbi.nlm.nih.gov

Conservative treatment of thoracic outlet syndrome using an orthosis. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

The Clinical Outcomes of Spinal Accessory to Suprascapular Nerve Transfer Through a Posterior Approach. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Percutaneous implantation of a brachial plexus electrode for management of pain syndrome caused by a traction injury. [2022]