Clinical Trials

Clinical trials provide access to breakthrough therapies for those seeking alternatives to surgery and other types of pain management. By participating, you’re playing an important role in the development of new treatments with the prospect of reducing or eliminating your pain.

Who Can Participate?

All clinical trials have specific guidelines about who can participate. Potential participants must qualify for a clinical trial. In most clinical trials, one group of patients will be given the experimental treatment, while the control group is given the standard treatment for their particular injury or disease.

How are Clinical Trials Funded and Regulated?

Clinical trials are sponsored and/or funded by a variety of organizations and/or individuals. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB). The IRB does this to ensure risks are as low as possible and are worth any potential benefits. The IRB also ensures that clinical trials are ethical, and the rights of study participants are protected. All institutions that conduct research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research being conducted.

Why Participate in a Clinical Trial?

Some of the benefits of participating in a clinical trial include:

  • Playing an active role in your own health care
  • Gaining access to new research treatments before they are widely available
  • Obtaining expert medical care during the trial
  • Helping others by contributing to medical research

Our Current Clinical Trials (needs updated list here)   I have added Evan and Alain to the email to add the updates as we have several additional trials to add and perhaps adjust the language and contact? research@pss.com or something?

Open to Enrollment:

 

  • Boston Scientific SCOPE – A 5-year Superion® IDS Clinical Outcomes Post-Approval Evaluation – NCT04192591
  • Boston Scientific RELIEF –  A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain – NCT01719055
  • Boston Scientific ENVISION – A Study to Characterize the Relationship Between Select Objective Metrics and Clinical Outcomes in Chronic Pain Patients Treated With Boston Scientific Neurostimulation Systems – NCT03240588
  • Boston Scientific PRO – Patient Retrospective Outcomes – NCT01550575
  • Boston Scientific FAST – Study to Demonstrate the Value of Paresthesia- Free Fast-Acting Subperception (FAST) and other SCS therapies using WaveWriter™ Spinal Cord Stimulator Systems in the Treatment of Chronic Pain – NCT04618471
  • Abbott REALITY – Long-Term Real-World Outcomes Study on Patients Implanted with a Neurostimulator – NCT03876054
  • Mainstay Medical RESTORE – ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation – NCT04803214
  • Nalu Medical COMFORT 2 – Clinical Study Of A Micro-Implantable Pulse Generator For the Treatment of Peripheral Neuropathic Pain – NCT05287373
  • SAOL 1010-01 – A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Escalation Study to Assess the Safety and Efficacy of SL-1002 Injectable for Treatment of Knee Pain Associated with Osteoarthritis – NCT05470608
  • Aurora REFINE – A Prospective, Observational, OpenLabel, Non-Randomized, Multi-Center Study Measuring Functional Outcomes In a Novel Interspinous Fusion Device In Subjects With Low Back Pain – NCT05504499

If you are interested in learning more about clinical trials and how you might participate, talk with your medical provider.