RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

Recruiting

• Conditions: Pain

• Registration Number: NCT01719055
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use

\- and -

To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice

Detailed Description

The study is a prospective, multi-center, global registry of Boston Scientific neurostimulation systems for pain.

The study treatment will consist of neurostimulation trial therapy with any commercially approved Boston Scientific Corporation neurostimulator for pain. Positive trials, subjects with a successful trial outcome, may progress to permanent implant of a neurostimulation system. Individualization of neurostimulation therapy for pain will be determined according to investigator discretion and site routine care, and in accordance with inclusion and exclusion criteria.

Study Timeline

• Study First Submitted: 2012-10-30
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-01
• Study Start: 2012-11-19
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-11
• Last Update Posted: 2025-09-12
• Primary Completion: 2035-05
• Study Completion: 2035-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4800

Inclusion Criteria

• Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use
• Signed a valid, IRB/EC-approved informed consent form
• 18 years of age or older

Key

Exclusion Criteria

• Contraindicated for Boston Scientific neurostimulation system
• Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (110)

Physicians Research Group, LLC; 🇺🇸 Phoenix, Arizona, United States

Hope Research Institute; 🇺🇸 Las Vegas, Nevada, United States

Banner University Medical Center; 🇺🇸 Tucson, Arizona, United States

Comprehensive Pain Management Center; 🇺🇸 Campbell, California, United States

Coastal Research Institute; 🇺🇸 Carlsbad, California, United States

Pain Medicine Associates, Inc.; 🇺🇸 Fountain Valley, California, United States

Metropolitan Pain Management Consultants Inc.; 🇺🇸 Sacramento, California, United States

Huntley Pain Specialists; 🇺🇸 San Diego, California, United States

Conejo Pain Specialists; 🇺🇸 Thousand Oaks, California, United States

South Lake Pain Institute, Inc; 🇺🇸 Clermont, Florida, United States

Scroll for more (100 remaining)