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Long-term outcomes for patients with neurostimulators for chronic pain

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

Abbott Medical Devices · NCT03876054

This study is testing how well Abbott's neurostimulators work for managing chronic pain over a long period in patients who are getting them implanted.

Quick facts

Study typeObservational
Enrollment2000 (estimated)
Ages18 Years and up
SexAll
SponsorAbbott Medical Devices (industry)
Locations55 sites (Phoenix, Arizona and 54 other locations)
Trial IDNCT03876054 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled to receive an Abbott neurostimulation system and have a baseline pain score of 6 or higher.

Not a fit: Patients with certain comorbid conditions or those enrolled in competing clinical studies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of neurostimulation for chronic pain relief.

How similar studies have performed: Other studies on neurostimulation for chronic pain have shown promising results, indicating that this approach is supported by previous research.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Phoenix, Arizona and 54 other locations

+5 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Chronic Pain, spinal cord stimulation, dorsal root ganglion stimulation

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.