Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator

Recruiting now

Conditions studied: Chronic Pain

In brief

The REALITY study is a prospective, post-market, non-randomized, multi-center, single-arm, open-label study intended to collect short- and long-term safety and effectiveness data on various populations implanted with Abbott's neurostimulation systems.

Key facts

Study ID

NCT03876054

Run by

Abbott Medical Devices

People needed

2000

Starts

2019-03-13

Expected to finish

2029-12-01

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must provide written informed consent prior to any clinical investigation related procedure.
• Subject is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment.
• Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline.
• Subject has a baseline (with no stimulation) pain NRS of ≥ 6.

You may not qualify if…

• Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements.
• Subject has or is scheduled to receive an intrathecal pump.
• Subject is part of a vulnerable population.
• Subject has an existing implanted neuromodulation device to address their chronic pain.

Where it is running

• Krankenhaus Porz am Rhein — Cologne, Koln, Germany (enrolling)
• California Orthopedics & Spine — Larkspur, California, United States
• Nevada Advanced Pain Specialists — Reno, Nevada, United States
• Foothills Pain Management Clinic — Pomona, California, United States
• Pacific Research Institute — Santa Rosa, California, United States
• University of Florida Department of Anesthesia — Gainesville, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Goodman Campbell Brain and Spine — Indianapolis, Indiana, United States
• Nura — Edina, Minnesota, United States
• Twin Cities Pain Clinic — Edina, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Saint Louis Pain Consultants — Chesterfield, Missouri, United States
• Advanced Pain Care — Henderson, Nevada, United States
• Restore Orthopedics & Spine Center — Orange, California, United States
• Ainsworth Institute of Pain Management — New York, New York, United States
• Unity Spine Center — Rochester, New York, United States
• The Spine & Pain Institute of New York — Staten Island, New York, United States
• Premier Pain Solutions — Asheville, North Carolina, United States
• Adena Bone and Joint Center — Chillicothe, Ohio, United States
• Premier Pain Treatment Institute — Loveland, Ohio, United States
• Pacific Sports & Spine — Eugene, Oregon, United States
• Spinal Diagnostics — Tualatin, Oregon, United States
• Center for Interventional Pain & Spine — Exton, Pennsylvania, United States
• Pain Institute of Southern Arizona — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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