EVOKE ECAP-Controlled Lead Placement and Programming in Chronic Pain Patients
This study is investigating a new method for placing and setting up spinal cord stimulation (SCS) devices for people with ongoing lower back pain. SCS involves a small device under the skin that sends electrical pulses to the spinal cord to help reduce pain. Currently, getting these devices to work well can be tricky, especially for back pain. This research aims to use special recordings of nerve signals during the surgery to help doctors place the device more accurately and ensure it's stimulating the right nerves. The main goal is to see if this new approach can lead to better, longer-lasting pain relief by making sure the device is set up perfectly from the start.
At a glance
What is this study about?
This study is about improving how we treat ongoing lower back pain using a device called a spinal cord stimulator (SCS). An SCS is a small device surgically placed under the skin, with thin wires (leads) going into the space around your spinal cord. These wires deliver mild electrical pulses that change how your brain receives pain signals, hopefully reducing your pain.
Traditionally, placing and setting up these devices has been a bit challenging, especially for back pain. Doctors often rely on your feedback during surgery and seeing if you feel a tingling sensation (called paraesthesia) over the painful area. However, it's not always easy to get this sensation to cover all the painful spots perfectly, and the relief can sometimes wear off over time.
This new study is testing a different, more precise approach. During the surgery to place the SCS wires, doctors will use special techniques to measure nerve signals directly. These measurements, called ECAP and Late-Response (LR) recordings, act like a map, helping the surgeon know exactly where to place the wires for the best possible pain relief. The idea is that by accurately targeting the nerves from the very beginning, the SCS device will work better and provide more consistent and lasting relief for people with persistent low back pain.
Key takeaways
- This study explores a new way to make spinal cord stimulators work better for back pain.
- It uses nerve signal measurements during surgery for more accurate device placement.
- The aim is to achieve more reliable and lasting pain relief for chronic lower back pain.
- You need to have experienced lower back pain for at least 6 months to be considered.
- It's for adults aged 18-75 who haven't had a spinal cord stimulator before.
Who may be eligible?
This study is looking for adults aged between 18 and 75 years old who have been experiencing ongoing lower back pain for at least six months. Your pain should be at a moderate level (5 out of 10 or higher on a pain scale). You also need to be well enough for the surgery, able to understand and sign consent forms in English, and willing to attend all study appointments.
There are also some reasons why you might not be able to join. For example, if you have other medical problems or pain elsewhere that might make it hard to tell if the treatment is working. You can't join if you have a significant mental health problem, abuse alcohol, or if you've recently had other procedures that successfully treated your pain. If you've had a spinal cord stimulator before, or have other electronic implants like a pacemaker, or are pregnant or nursing, you won't be able to take part.
- Are you between 18 and 75 years old?
- Have you had ongoing lower back pain for at least 6 months, usually rating 5/10 or higher?
- Are you able to understand and sign forms in English?
- Have you NOT had a spinal cord stimulator before?
- Are you NOT pregnant or breastfeeding?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would first have a full medical check-up to make sure this study is right for you. The main part of the study involves surgery to implant the spinal cord stimulator (SCS) device. During this surgery, special recordings will be taken from your nerves to help the doctors place the wires in the best possible position. After the surgery, you'll have regular follow-up appointments to check how you're feeling and how well the device is working. We will specifically check your pain levels using a simple questionnaire after three months. The total duration of your involvement in the study will be discussed with you by the study team.
Potential risks and benefits
Locations (1)
- Barts Health NHS TrustLondon, United Kingdom· Recruiting
Common questions
What is a spinal cord stimulator?
It's a small device like a pacemaker that's put under your skin. It sends mild electrical pulses to your spinal cord to help block pain signals to your brain.
What is 'ECAP' and 'LR'?
These are special ways doctors measure tiny nerve signals during surgery. They act like a guide to help place the stimulator wires in exactly the right spot.
Will I feel tingling with this new method?
The goal is to get better pain relief. Some older methods relied on a tingling sensation, but this study aims for more precise targeting, which could mean different sensations or improved relief.
Is this a new type of stimulator?
While the stimulator itself might be similar, this study is testing a new, more advanced way of placing and setting up the device to make it work better, especially for back pain.
How long will the study last for me?
You will have a follow-up after the device is implanted to see how your pain changes, specifically at 3 months. The full duration of your participation will be explained by the study team.
How to find out more
Serge Nikolic
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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