Pain Management Clinical Trials


RELIEF Study - ENVISION Cohort

Description
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.

Currently enrolling

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.

Investigator: Jennifer M Lee, MD, EvergreenHealth Pain Care

For more information: contact EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@evergreenhealth.com


RELIEF

A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

Description
The RELIEF study is a prospective, multi-center, global registry of Boston Scientific neurostimulation systems for pain. The goal of the RELIEF study is to collect information about adult chronic pain patients who are using a Boston Scientific neurostimulation system.

Currently enrolling

Who may be eligible to participate?
Adults with chronic low back pain or chronic leg pain who is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain. Eligible subjects must be 18 years of age or older. Other inclusion and exclusion criteria may apply.

What does participation involve?
If it is determined that you have met all of the study requirements and are willing to participate in the study, you will:
• Be required to provide data at a Baseline, Trial and Implant visit.
• Be asked to complete pain drawings and questionnaires related to your experience with pain
• Be scheduled for follow-up visits at your study doctor’s office: 6, 12, 24, and 36 months after your trial procedure.
• You may receive compensation for your participation in this study.

Investigator: Jennifer M Lee, MD, EvergreenHealth Pain Care

For more information: contact EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@evergreenhealth.com