RecruitingOBSERVATIONAL

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

The RELIEF study is checking how well a type of pain treatment called neurostimulation, made by Boston Scientific, works for people with long-term pain. This isn't a new drug trial; it's looking at devices already approved and used in clinics. Researchers want to see the real-world experiences of patients, including how effective the treatment is over time, how it performs, and if it offers good value. By gathering this information from many different clinics around the world, the study aims to understand the long-term benefits and practical use of these nerve stimulation systems.

At a glance

Status

Recruiting

Sponsor

Boston Scientific Corporation

Enrolment target

4,800

Start

19 Nov 2012

Estimated completion

01 May 2035

Pain

What is this study about?

This study, called RELIEF, is looking at how a special type of pain treatment, known as neurostimulation, works for people suffering from ongoing pain. Neurostimulation involves using a small device to send mild electrical signals to nerves, which can help reduce pain signals to the brain. The devices being studied are made by Boston Scientific and are already approved for use, so this isn't about testing a new, experimental treatment.

The main purpose of the study is to gather information from many different clinics all over the world about how well these devices actually help patients in their daily lives. Researchers want to understand the long-term effects, how reliable the devices are, and if they offer good value. This means they will be collecting details about patients' pain levels, how they feel about the treatment, and how their quality of life might improve.

By carefully observing how these treatments are used in regular medical care, the study hopes to get a clear picture of their benefits and how they perform outside of strict research settings. This information can then help doctors and patients make more informed decisions about pain management in the future.

Key takeaways

The study looks at approved nerve stimulation devices for pain.
It aims to understand long-term effects in real-life patients.
It’s not testing new treatments, but observing existing ones.
Participation involves sharing data from your routine care.
You must be 18 or older and considered suitable for this treatment.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you generally need to be at least 18 years old. You must be scheduled to try out a Boston Scientific nerve stimulation system for your pain, as advised by your doctor according to the official instructions for the device.

Before you start, you'll need to read and sign a special form called an 'informed consent form'. This form explains everything about the study in detail, and signing it means you understand what's involved and agree to take part. It's important to have this conversation with your doctor first.

You won't be able to join if you have a medical condition that would make it unsafe for you to have a Boston Scientific neurostimulation system, or if your doctor believes you have memory or thinking problems that would make it difficult for you to understand the study or report your pain levels accurately.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Has your doctor recommended a Boston Scientific nerve stimulation device for your pain?
Are you able to understand and sign consent forms?
Do you not have any other medical conditions that would make this treatment unsafe for you?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your doctor will first assess if a nerve stimulation device is suitable for your pain. If so, you'll start with a temporary 'trial' period where you'll use a neurostimulation system to see if it helps reduce your pain. This trial is part of your normal care for pain relief.

If this trial is successful and helps your pain, you might then have a permanent neurostimulation system implanted. The study will mainly involve your doctors gathering information from your regular check-ups about how you're feeling, your pain levels, and how the device is working. There won't be any extra study visits beyond your usual medical appointments. The duration of your participation will depend on how long you use the neurostimulation system, as the study aims to follow long-term outcomes to see how well it works over time.

Potential risks and benefits

Taking part in this study means you'll be receiving a treatment that your doctor believes could help manage your pain. The potential benefit is that the neurostimulation system could provide significant long-term relief from your pain, improving your quality of life. As with any medical procedure, there are potential risks associated with the neurostimulation system itself, such as infection, bleeding, or issues with the device, which your doctor will discuss fully with you. There are no additional risks from being 'in the study' itself, as it mainly involves collecting information from your routine care. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (118)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Physicians Research Group, LLC
Verified postcode
Phoenix, United States· Terminated
Hope Research Institute
Verified postcode
Phoenix, United States· Terminated
Banner University Medical Center
Verified postcode
Tucson, United States· Completed
Comprehensive Pain Management Center
Verified postcode
Campbell, United States· Terminated
Coastal Research Institute
Verified postcode
Carlsbad, United States· Terminated
Pain Medicine Associates, Inc.
Verified postcode
Fountain Valley, United States· Terminated
Metropolitan Pain Management Consultants Inc.
Verified postcode
Sacramento, United States· Terminated
Huntley Pain Specialists
Verified postcode
San Diego, United States· Withdrawn
Conejo Pain Specialists
Verified postcode
Thousand Oaks, United States· Terminated
Denver Back Pain Specialists
Verified postcode
Greenwood Village, United States· Recruiting
Orlando Health Neuroscience Institute, Inc
Verified postcode
Clermont, United States· Recruiting
South Lake Pain Institute, Inc
Verified postcode
Clermont, United States· Recruiting

Common questions

What is neurostimulation?

Neurostimulation uses a small device implanted under your skin to send mild electrical signals to specific nerves, which can help block or change pain signals.

Is this a new or experimental treatment?

No, the study is looking at Boston Scientific neurostimulation systems that are already approved and regularly used to treat pain, not new or experimental ones.

Will I get special treatment if I join?

You will receive the same high-quality care you would normally get for your pain; the study is just observing how the treatment works in real-world settings.

Do I have to pay to join the study?

No, you shouldn't have to pay to participate in the study itself. Any costs related to your medical treatment would be handled as they normally are.

Can I leave the study at any time?

Yes, you are completely free to stop participating in the study at any point, and your decision will not affect your relationship with your doctors or your future medical care.

How to find out more

Thanh Hoang, MS

BSNClinicalTrials@bsci.com 855-213-9890 Official trial record

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