FAST Spinal Cord Stimulation for Chronic Pain

(FAST Trial)

This trial explores new ways to relieve chronic pain using the Boston Scientific WaveWriter SCS System, which provides various settings for spinal cord stimulation. The goal is to evaluate the effectiveness of fast-acting, paresthesia-free therapy (without tingling or buzzing sensations) compared to other options. It targets individuals who have experienced chronic pain primarily in their back or limbs for over six months, with back pain being more severe than leg pain. Those who can read and complete forms in English and have been dealing with this type of pain might be suitable for this study. As an unphased trial, this study offers a unique opportunity to explore innovative pain relief methods and contribute to advancing chronic pain treatment options.

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

Research has shown that the Boston Scientific WaveWriter Spinal Cord Stimulation (SCS) System is generally safe for people with chronic pain. Studies have found that this system can significantly reduce pain for many patients. Specifically, one study reported that 84% of patients experienced at least a 50% reduction in pain after using the WaveWriter System for a year.

The FDA has approved the SCS System for treating chronic pain in the back and legs, indicating it is well-tolerated. Additionally, it is designed to be safe for patients who need full-body MRI scans, highlighting its safety features.

Researchers are excited about the Boston Scientific WaveWriter SCS System for chronic pain because it offers a unique approach to spinal cord stimulation. Unlike traditional treatments, which often rely on fixed stimulation patterns, the WaveWriter system allows for personalized pain relief by offering multiple waveforms and frequencies. This flexibility enables the system to be tailored to each patient's specific pain needs, potentially providing more effective and longer-lasting relief. Additionally, the WaveWriter's ability to combine different types of stimulation simultaneously could enhance its effectiveness and improve patient outcomes compared to standard spinal cord stimulation devices.

Research has shown that the Boston Scientific WaveWriter SCS System, used by participants in this trial, effectively manages chronic pain. In studies, 84% of patients using this system reported significant pain relief of 50% or more after one year. Unlike some other treatments, this system provides pain relief without causing a tingling sensation. The WaveWriter SCS System can also combine different therapy modes, potentially improving long-term results for patients. Extensive clinical evidence supports this device, proving its effectiveness in managing chronic pain in the trunk and/or limbs.¹²⁴⁶⁷