Treatment Systems for Chronic Pain
(PRO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how different treatments assist people with chronic pain. Researchers will use anonymous medical records to evaluate the effectiveness of Boston Scientific Systems and other devices. Individuals who have used or may need a spinal cord stimulator (a device to help reduce pain) or have tried other pain treatments might be suitable for this study. The research aims to determine which treatments are most effective for managing ongoing pain. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to the validation of potentially effective treatments.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that spinal cord stimulation (SCS) systems, including those from Boston Scientific, are generally safe. Studies have found that most patients tolerate these systems well. Multiple thorough studies, including those in real-world settings, support this conclusion, confirming their safety and effectiveness over time. Some common issues, such as discomfort at the implant site, can occur but are usually manageable.
For systems not made by Boston Scientific, long-term safety data indicates they are generally safe for treating chronic pain, although detailed information beyond two years remains limited. Any implanted device carries some risk, but many people have successfully used these systems to manage their pain. Prospective trial participants should discuss potential risks and benefits with a healthcare provider.12345Why are researchers excited about this trial?
Researchers are excited about the treatments in the Patient Retrospective Outcomes trial because they are exploring different approaches to managing chronic pain using spinal cord stimulation (SCS) systems and other methods like radiofrequency (RF) and intrathecal drug delivery systems (IDS). Unlike traditional pain management options, which might rely heavily on medications, these treatments aim to directly modulate nerve activity to reduce pain. This approach could offer a more targeted relief with potentially fewer systemic side effects. Additionally, the trial investigates how switching between different SCS systems or combining them with other treatments might enhance overall effectiveness for patients who have previously undergone similar procedures.
What evidence suggests that this trial's treatments could be effective for chronic pain?
Research has shown that spinal cord stimulation (SCS) can help relieve chronic pain. Four top-quality studies and several real-world studies support its use, demonstrating significant and lasting pain relief. In this trial, participants may receive Boston Scientific’s SCS therapy, which has successfully managed chronic low back and leg pain. However, a recent review suggested that SCS might not be more effective than a placebo for low back pain specifically. Overall, experts agree that SCS is among the most effective treatments for chronic pain, though its effectiveness can vary depending on the specific condition.36789
Who Is on the Research Team?
Natalie Bloom Lyons
Principal Investigator
Boston Scientific Neuromodulation Corporation
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Data Review
Retrospective review of de-identified patient data to evaluate clinical outcomes of various treatment approaches for chronic pain
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Boston Scientific Systems
- Non Boston Scientific Systems
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Scientific Corporation
Lead Sponsor
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