The ENVISION study is a prospective, post-market, multi-center study of Boston Scientific neurostimulation systems for pain. The goal of the ENVISION study is to characterize the relationship between select objective metrics and clinical outcomes in chronic pain patients treated with Boston Scientific commercially approved neurostimulation systems.
Who may be eligible to participate?
Adults with chronic low back pain or chronic leg pain who are planning to receive or have received a commercially approved Boston Scientific neurostimulation system for pain.
Eligible subjects must be 18 years of age or older. Subjects enrolled in the main RELIEF study are not eligible to participate. Other inclusion and exclusion criteria may apply.
What does participation involve?
Study duration for each subject is expected to be approximately 12 months. Study assessments will be required, as appropriate, at the following time points:
- Enrollment Visit (Day 0)
- 1-Month Post-Enrollment Visit (30 days ± 10 days)
- 3-Month Post-Enrollment Visit (90 days ± 10 days)
- 12-Month Post-Enrollment Visit (365 days + 30 days)
- Additional Study Visit for SCS device related activities (e.g. SCS trial, end of SCS trial, IPG implant, IPG activation, reprogramming, revision, etc.) or as needed for the study.
Jennifer M Lee, MD, EvergreenHealth Pain Care