Long-term outcomes for patients with neurostimulators for chronic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The REALITY study is an observational, multi-center study designed to gather data on the safety and effectiveness of Abbott's neurostimulation systems in patients with chronic pain. It aims to enroll up to 2,000 subjects who are scheduled to receive an implantable neurostimulator, with a follow-up period of five years for each participant. The study has broad inclusion criteria to reflect real-world usage and will collect both short- and long-term outcomes over a total duration of 13 years. This approach allows for a comprehensive understanding of the impact of neurostimulation on chronic pain management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject must provide written informed consent prior to any clinical investigation related procedure.
2. 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.
3. Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline.
4. Subject has a baseline (with no stimulation) pain NRS of ≥ 6.

Exclusion Criteria:

1. Subject is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
2. 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.
3. Subject has or is scheduled to receive an intrathecal pump.
4. Subject is part of a vulnerable population.
5. Subject has an existing implanted neuromodulation device to address their chronic pain.

Where it's running

• Krankenhaus Porz am Rhein
  Cologne, Koln, Germany Recruiting
• Phoenician Centers for Research & Innovation
  Phoenix, Arizona, United States Terminated
• Pain Institute of Southern Arizona
  Tucson, Arizona, United States Terminated
• California Orthopedics & Spine
  Larkspur, California, United States Terminated
• Restore Orthopedics & Spine Center
  Orange, California, United States Terminated
• Foothills Pain Management Clinic
  Pomona, California, United States Terminated

+5 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Bram Blomme
• Email: bram.blomme@abbott.com
• Phone: +32 474 74 83 10

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.