RecruitingNAINTERVENTIONAL

Spinal Cord Stimulation for Chronic Abdominal Pain Patients

If you suffer from ongoing abdominal pain that hasn't gotten better with usual treatments, this study might be for you. Researchers are testing a new type of spinal cord stimulator. This small device is placed under the skin and sends mild electrical signals to your spine to help reduce pain. Unlike older versions, this new device is designed to work without causing any uncomfortable tingling sensations in your tummy. They want to see how well it works and if it's a good option for people living with chronic abdominal pain. The study involves a small number of participants and includes several check-ups after the device is put in.

At a glance

Status

Recruiting

Phase

Sponsor

The Leeds Teaching Hospitals NHS Trust

Enrolment target

Start

18 Jan 2024

Estimated completion

04 Jun 2025

Pain

What is this study about?

Living with ongoing tummy pain can be really tough and can affect your daily life a lot. While there are different medicines available, sometimes they don't work well enough, can have side effects, or their effects might wear off over time. This study is exploring a new approach called spinal cord stimulation (SCS) as a way to manage this kind of pain.

Spinal cord stimulation involves a small device, a bit like a tiny computer, being placed under your skin, usually in your back or tummy area. This device sends very gentle electrical signals to your spinal cord. These signals can help to interrupt or change the pain messages that travel to your brain, making the pain feel less intense. Older versions of these devices sometimes caused a tingling feeling in the painful area, which could be uncomfortable for some people.

The exciting part about this particular study is that it's testing a newer type of spinal cord stimulator that's designed *not* to cause that tingling sensation. The researchers want to see if this new approach can effectively reduce chronic tummy pain without any unpleasant feelings. They're looking for up to 20 people to take part and help them understand if this could be a good, long-term treatment option.

Key takeaways

This study explores a new way to treat chronic tummy pain using a special device.
The device sends gentle electrical signals to your spinal cord to ease pain.
Crucially, this new device aims to reduce pain without causing uncomfortable tingling.
It's for people whose tummy pain hasn't responded to other treatments.
If eligible, you'll have a small operation and regular check-ups for a year.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to have been diagnosed with ongoing tummy pain that goes from your groin to your lower ribs. This pain should have affected you for at least three months and hasn't improved much with other treatments, like at least two different types of medicines or a nerve-blocking injection. Your pain should also be rated at least a '5' on a scale of 0 to 10.

You must be 18 years old or older, and your doctor needs to agree that you're healthy enough for the small surgery to implant the device. You also need to be able to understand what the study involves and be willing to attend all the appointments.

There are some reasons why you might not be able to join. For example, if you are pregnant or planning to be, have had certain other surgeries or treatments recently, or already have another implanted device like a pacemaker. Other reasons include having an active infection, being severely overweight, or having spinal issues that would make placing the device difficult. You also can't take part if you can't understand the study forms or how to use the device controls.

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.

Do I have ongoing tummy pain that has lasted at least 3 months?
Has my pain been rated at least a '5' out of 10?
Am I 18 years old or older?
Have I tried at least two different types of pain medicines without much success?
Am I willing and able to attend all clinic appointments?
Do I currently *not* have another implanted device like a pacemaker or another SCS?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your journey will start with an initial visit where you'll complete some questionnaires about your pain and general health. After this, you'll have a hospital appointment for a small operation to carefully place the spinal cord stimulation device under your skin. During this time, the medical team will also adjust the device's settings to best suit your needs.

Once the device is active, you won't be left on your own. You'll have regular in-person check-ups at the pain clinic to make sure you're doing well and to monitor your pain. These follow-up visits will be scheduled at one week, three months, six months, and twelve months after your device is put in. Throughout the study, you'll be continuously supported by the medical team.

Potential risks and benefits

Taking part in this study could offer the benefit of significant pain relief from your chronic abdominal pain, especially if other treatments haven't worked for you. It might also improve your quality of life. As with any medical procedure, there are potential risks associated with the surgery to implant the device, such as infection or bleeding. There's also the chance the device might not work for you, or there could be other unexpected side effects. The study team will explain all known risks to you in detail. Remember, your participation is completely voluntary; you are free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (1)

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

Leeds Teaching Hospitals NHS Trust
Verified postcode
Leeds, United Kingdom· Recruiting

Common questions

What is 'chronic abdominal pain'?

It's ongoing tummy pain that you've had for a long time, often at least three months, and can really impact your life.

What is spinal cord stimulation?

It's when a small device placed under your skin sends gentle electrical signals to your spinal cord to help reduce pain.

Will this device cause a tingling feeling?

No, this specific study is testing a new type of device designed not to cause any uncomfortable tingling feelings.

How long will the study last?

You'll have follow-up visits for up to 12 months after the device is implanted.

Is the surgery difficult?

It's a minimally invasive, small operation to place the device, and your doctor will decide if it's suitable for you.

How to find out more

Emma Binns, BSc

leedsth-tr.leedspainresearch@nhs.net 0113 3926234 Official trial record

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