RecruitingOBSERVATIONAL

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

This study, called REALITY, is for people in the UK who are getting a special device called an Abbott neurostimulator to help with their long-term pain. Researchers want to understand how safe and effective these devices are in real-world situations, both soon after they’re put in and many years later. They are looking at different types of neurostimulators, including those for the spinal cord or dorsal root ganglion. The study will gather information from many people to get a clear picture of how these devices help people manage their chronic pain over time. It's a key step in ensuring these treatments are helpful and safe for patients.

At a glance

Status

Recruiting

Sponsor

Abbott Medical Devices

Enrolment target

2,000

Start

13 Mar 2019

Estimated completion

01 Dec 2029

Chronic Pain

What is this study about?

Imagine living with long-term pain every day. For some people, special devices called neurostimulators can offer a way to manage this pain. These small devices are placed in the body and send gentle electrical pulses to nerves to help reduce pain signals. This study, called REALITY, is designed to see how well these Abbott neurostimulators work for people in their everyday lives.

Researchers want to understand if these devices are safe and effective for patients with ongoing pain, not just in strict testing environments, but when people are actually using them. They will be looking at different kinds of neurostimulators, such as those that work on the spinal cord (SCS) or a specific nerve cluster called the dorsal root ganglion (DRG).

By collecting information from lots of people who receive these devices, the study will build a comprehensive picture of their long-term benefits and any potential challenges. This helps doctors and patients make informed decisions about pain management in the future.

Key takeaways

The REALITY study looks at how well Abbott neurostimulators work for long-term pain.
It aims to understand safety and effectiveness in everyday life over many years.
The study includes spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation.
About 2,000 people will participate, with individual follow-up lasting five years.
Joining helps doctors learn more about helpful pain management options.
Your medical care isn't affected if you join or leave the study.

Who may be eligible?

To join this study, you need to be at least 18 years old and scheduled to have an Abbott neurostimulation system implanted within the next two months. You should also be experiencing a significant level of pain (scoring 6 or more out of 10 on a pain scale) before the device is put in. This helps the researchers see how much the device truly helps your pain.

There are a few reasons why you might not be able to join. For example, if you are already in another similar study or planning to be in one, you wouldn't be able to participate. Also, if a doctor believes other health problems or personal situations might make it hard for you to complete the study or attend follow-up appointments, you might not be eligible. If you already have a neurostimulation device implanted for pain or are going to receive a different type of pain pump, you also wouldn't qualify.

Quick self-check

Are you at least 18 years old?
Are you scheduled to get an Abbott neurostimulator for pain within the next 60 days?
Is your pain score usually 6 out of 10 or higher without stimulation?
Are you not in another similar medical study?
Do you not already have a similar device implanted for your pain?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the study, you'll be one of up to 2,000 people across various medical centers. The researchers will follow your progress for five years after your neurostimulator is implanted. This follow-up will involve regular check-ups and assessments to record how the device is working for you and if you experience any issues. The full study, including enrolling new participants and collecting all the data, is expected to take about 13 years in total. During this time, you will continue to use your neurostimulator as planned by your doctor, and the study will simply collect information about your experience.

Potential risks and benefits

Participating in this study means contributing valuable information that could help others with chronic pain in the future, as it helps us understand the long-term effectiveness of these devices. There are no additional risks beyond those normally associated with getting a neurostimulation device. As with any medical treatment, there are potential risks and benefits that your doctor will discuss with you. You are free to withdraw from the study at any time without affecting your medical care.

Locations (55)

Phoenician Centers for Research & Innovation
Phoenix, United States· Terminated
Pain Institute of Southern Arizona
Tucson, United States· Terminated
California Orthopedics & Spine
Larkspur, United States· Terminated
Restore Orthopedics & Spine Center
Orange, United States· Terminated
Foothills Pain Management Clinic
Pomona, United States· Terminated
Pacific Research Institute
Santa Rosa, United States· Terminated
University of Florida Department of Anesthesia
Gainesville, United States· Terminated
Rush University Medical Center
Chicago, United States· Active not recruiting
University of Chicago
Chicago, United States· Active not recruiting
Goodman Campbell Brain and Spine
Indianapolis, United States· Active not recruiting
Nura
Edina, United States· Active not recruiting
Twin Cities Pain Clinic
Edina, United States· Terminated

+43 more sites — see the official record for the full list.

Common questions

What is a neurostimulator?

A neurostimulator is a small device implanted in your body that sends gentle electrical pulses to nerves to help manage chronic pain.

What kind of pain does this study focus on?

This study is for people who experience ongoing, long-term pain, often called chronic pain.

How long will I be in the study if I join?

If you join, researchers will follow your progress for five years after your neurostimulator is implanted.

Do I have to do anything extra as part of the study?

The study mainly involves collecting information about your usual care and experience with the neurostimulator during your regular follow-up appointments.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it will not affect the medical care you receive.

How to find out more

Bram Blomme

bram.blomme@abbott.com +32 474 74 83 10 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.