Neurostimulation Therapy for Chronic Pain

(RELIEF Trial)

Recruiting at 31 trial locations

Overseen By Thanh Hoang, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Disqualifiers: Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

4800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a neurostimulation system from Boston Scientific for individuals experiencing pain. Neurostimulation uses a device to send mild electrical signals to nerves to help relieve pain. The researchers aim to assess the system's cost-effectiveness and performance in daily life. Those considering a Boston Scientific neurostimulation device for pain relief might find this trial suitable. As a Phase 3 trial, it represents the final step before FDA approval, providing an opportunity to contribute to the validation of a potentially effective treatment.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the Boston Scientific neurostimulation systems?

Research shows that Boston Scientific's neurostimulation systems are generally well-tolerated. Several studies, including four top-level clinical trials and four real-world studies, have supported these systems. These studies confirm the treatment's effectiveness and safety in managing pain.

While the systems may not suit everyone, such as those unable to use them or who have experienced poor surgical outcomes, many patients have used them safely. Importantly, the FDA has already approved this treatment for pain management, indicating a strong safety record. Overall, the data show that the neurostimulation system is a reliable option for those seeking pain relief. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about neurostimulation therapy for pain because it offers a unique approach compared to traditional pain treatments like opioids and physical therapy. Unlike medications that need to be taken regularly or therapies that require frequent sessions, neurostimulation systems work by delivering electrical impulses directly to the spinal cord, potentially providing long-term pain relief with fewer side effects. This therapy targets the nervous system directly, which can lead to more precise pain management and improved quality of life for patients suffering from chronic pain conditions.

What evidence suggests that the Boston Scientific neurostimulation system is effective for pain?

Research has shown that Boston Scientific's neurostimulation systems, which participants in this trial may receive, effectively reduce chronic pain. In one study, many patients reported their pain was cut in half. This treatment also improves quality of life, enabling greater participation in daily activities. The systems send electrical signals to the nerves, which can block pain signals from reaching the brain. Due to its proven success, the neurostimulation system is considered a good option for managing chronic pain.

Who Is on the Research Team?

Natalie Bloom Lyons

Principal Investigator

Boston Scientific Corporation

Are You a Good Fit for This Trial?

Inclusion Criteria

Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use

Signed a valid, IRB/EC-approved informed consent form

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Trial Therapy

Participants undergo neurostimulation trial therapy to assess suitability for permanent implant

4-6 weeks

Permanent Implant

Subjects with successful trial outcomes receive a permanent implant of the neurostimulation system

Varies based on individualization of therapy

Follow-up

Participants are monitored for safety, effectiveness, and quality of life improvements

Up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Neurostimulation System

How Is the Trial Designed?

Group I: Boston Scientific SCS Systems Experimental Treatment 1 Intervention

Subjects permanently implanted with a Boston Scientific neurostimulation systems

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Citations

1. bostonscientific.com bostonscientific.com/en-US/patients-caregivers/device-support/scs/medical-procedure-safety.html

MRI & Medical Safety Information For Your SCS System Contraindications: The Boston Scientific Spinal Cord Stimulator systems are not for patients who are unable to operate the system, have failed trial stimulation ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/P030017S275B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The following patients are contraindicated from being treated with Boston Scientific. Spinal Cord Stimulator Systems: • Poor surgical candidates;. • Unable to ...

3. bostonscientific.com bostonscientific.com/en-US/medical-specialties/pain-management/scs-clinical-data.html

Spinal Cord Stimulation (SCS) Clinical Data Unmatched clinical data supporting SCS. Boston Scientific's multiple mechanism SCS therapy is proven by 4 Level I RCTs and 4 Real-world Studies.

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/P030017S357B.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) The following patients are contraindicated from being treated with Boston Scientific. Spinal Cord Stimulator Systems: • Poor surgical candidates;. • Unable to ...

5. pain.com pain.com/en/indications-safety-warnings.html

Boston Scientific Spinal Cord Stimulator (SCS) Systems Access important safety information about various Boston Scientific treatments, devices, and procedures used for pain management.