Pain Service - Lumbar Multifidus Restorative Neurostimulation for Chronic Lower Back Pain (CLBP)

This information leaflet has been written by the Pain Management team at the Manchester and Salford Pain Centre. It is intended for patients (or their family or carers) who may be referred to our service for consideration of Lumbar Multifidus Restorative Neurostimulation. The information in this leaflet will help you decide whether the therapy is right for you.

What is the mutifidus muscle and why is it important?

There is an important muscle in the lower part of the back called the multifidus muscle. Think of it like the special glue that helps support the back and help control movement. If this muscle isn't strong or it's not working well, it can make back pain worse. This can happen when the muscle gets smaller or when the muscle becomes fatty and doesn't do its job well, due to not being used properly. When the multifidus muscle and other parts of the back don't work together like a team, the back can hurt a lot.

The role of the multifidus is to stabilise the spine. Without proper control of the multifidus muscle, the stability of the spine is compromised, leaving it susceptible to further injury and overloading. Think of the muscles in your lower back like a team that needs to work together to keep your spine, which is like the main pole in a tent, stable and straight. If the team isn't working well, the tent can wobble and even hurt.

Many people who have long-term back pain might not be using their back muscles in a coordinated way, usually subconsciously. This can lead to the muscle being used less effectively and altering control of back movement and allowing the muscle to become more fatty and work less well.

How does Lumbar Multifidus Restorative Neurostimulation work?

ReActiv8 otherwise known as multifidus restorative neurostimulation, is a special kind of treatment that helps people who have back pain due to their lower back muscles not working well. It helps to get the muscle and the nerves in the back to work together to help control back movement, posture and pain. This treatment works by sending tiny electrical impulses to the multifidus muscles on either side of the back, to help them work.

ReActiv8 is really easy for people to use. They have a little remote, just like the one for your TV, that they use to start a 30- minute muscle workout session. They can do this twice a day while they are lying down and relaxing. During this time, the muscles in their back will tighten up and then relax, repeatedly, which is like doing mini exercises without having to go to the gym. It's like giving the muscles a little reminder to do their job, helping to rewire the lost poorly functioning connections between your brain and the muscle.

While ReActiv8 does need a doctor to put some hardware inside the person's back near the nerves, it doesn't change your body in a big way. This is good because if they need other types of treatments later on, they can still access them.
 
Here is a diagrammatic representation of the device.

What happens before the procedure

• We provide you with information on the procedure and potential risks and benefits
• Increase your understanding of chronic pain and lumbar multifidus restorative neurostimulation
• Help you to work to realistic goals
• Maximise your psychological well being
• Introduce you to other patients who have similar experiences
• Provide support in decision making
• Give you the opportunity to learn about the components of the implant and what they look like

You may also be asked to stop certain medications like blood thinners by your doctor before the procedure.

You will need to fast before this procedure. You should not eat for at least six hours and have nothing to drink for up to two hours beforehand. The procedure is a day case, so you will be asked to bring someone with you to make sure you get home safely. Consent will also be confirmed on the day of surgery.

What does the operation involve?

Following all the pre-operative work up, your doctor will be present with you in theatre. The procedure is undertaken as a day case with light sedation. It involves a small cut being made to the lower back and two electrical leads inserted via a needle into the multifidus muscle. The needle is removed and the electrical leads which are thin wires remain in place. The wires are taken through the fat and inserted into a battery known as an implantable pulse generator, which is an implanted device, implanted in a small cut in the tissue of the buttock.

The procedure is undertaken with x-rays with testing of the muscles during the procedure, to ensure the leads are in the right place. The system is not visible from the outside. After the procedure, you will spend a short time in the recovery room before going back to your ward.

Is the procedure reversible?

The procedure is fully reversible, which means that the device can be removed if, after a period of time, the function of the multifidus is improved and the device is no longer required, or if the device is found to not bring benefit.

What happens after the operation?

Patients are usually discharged home the same day. You may need to take some pain killers for a short time. Pain in the area where the impulse pulse generator is placed should resolve after one to two weeks and any remaining discomfort or awareness of the implant should not last longer than three months.

You may feel some post-operative pain or discomfort in the area around the surgical cuts made to insert the electrode or pulse generator. These pains can last for up to 2-3 weeks, but will ease off as healing takes place.
 
You will have a dressing over the wounds. These need to remain in place for 2 weeks. Post operative advice will be given immediately after your procedure. Some blood loss into the dressing is normal, but please contact us if the dressing becomes saturated with blood.

If you notice any redness or swelling around the wound site or near to the implant, you will need to contact the pain centre for advice, or if out of hours contact your GP or go to accident and emergency. This is because you may require further assessment and in some cases a course of antibiotics if an infection is present.

You will return to the Centre about 10-14 days after your surgery and your stitches will be removed. About two weeks after the doctors put the machine in, a member of the nursing team and a company representative will teach you how to use a special remote control to turn the device on and off. At the same time the device will be activated, and you will be shown how to use it and carry out the stimulation sessions. You will take this remote home with you where you will use the device to start it yourself. You will be asked to do this twice a day for half an hour each time. While you're doing this, you need to lie down and relax.

You should limit strenuous activity in the first 6 weeks after your surgery to allow healing. When you get home after the procedure, you should rest for the remainder of the day. Do not attempt to drive or go to work.

You may need to take some pain killers for a short time. Pain in the area where the pulse generator is placed should resolve after one to two weeks, and any remaining discomfort or awareness of the implant should not last longer than three months.

After the procedure you should walk as much as possible but avoid twisting and stretching movements until the wounds have healed. You should limit strenuous activity in the first 6 weeks after your surgery to allow healing. This includes driving and any heavy lifting.

What are the risks of the procedure?

Apart from post procedural discomfort fewer common risks include:

• Pain around the impulse pulse generator implantation site. If this is severe, further surgery or removal of system may be advised
• Infection. If this happens, the whole system may need to be removed
• Bleeding, which may lead to minor bruising and in very rare cases may require further surgery
• The electrodes may move or stop working. This may require another operation to replace the electrode
• Failure to provide pain relief after regular use of the device. This may lead to a decision to remove the device

What does the stimulation feel like?

Most patients say the sessions feel like a pleasant series of deep muscle contractions, like flexing a muscle in an arm or leg, but in the lower back region. Most patients carry out their 30-minute therapy sessions once in the morning before getting out of bed and once in the evening when going to sleep or watching television. The system is programmed to be as comfortable as possible, so that it is easy and even enjoyable to perform the daily therapy sessions.

Once you are using the device, we will assess you again at the Pain Centre to ensure all is working well for you.

When can I expect pain relief

Most patients begin to feel an improvement in their ability to function and perform activities with improved confidence between 6 months to a year after the surgery, but it can take longer for some patients. The data from the clinical trials suggests that improvements seen in function and pain continue to accrue over time and are durable for many years. There is good evidence that the treatment can lead to a large reduction in back pain, reduced medication use, improved function and quality of life.

Is ReActive8 effective in everyone?

For patients with musculoskeletal back pain, the therapy is effective in around 70% of patients. The system can be removed if it is ineffective. It is important to realize that the system works by stimulating the muscles so they get stronger over time, and this can take many months. Hence pain relief does not start for many months.

What are the alternatives?

Alternatives include medications, pain management programmes and physio. Your team will assess you to help you make the right decision about which treatment is best for you.

Living with a ReActive8

During the first few weeks after the electrode is inserted, you need to avoid excessive lifting, bending or twisting to allow the leads to bed in. There are systems like airport security gates which have a magnetic field which can affect the Reactiv8. Some medical investigations, such as certain MRI scans are sometimes not allowed when a Reactiv8 has been implanted. The device does allow for MRI scans under certain conditions and your doctor or neuromodulation nurse can advise you in more detail. You will be followed up by our pain centre team to discuss your progress.

What happens next?

It is important that you understand the information in this leaflet. The doctor you have seen will refer you on to a consultant in the pain centre who specializes in Reactiv8 (unless you saw this consultant at your first visit).

After you have seen this consultant, you will then be referred to see our clinical psychologist. We include this step because Reactiv8 is a long-term commitment; to think about the way pain has affected your life and how we may be able to help you gain back some of the quality in your life. The final assessment is to see a specialist nurse in multifidus stimulation. They will assess your suitability for this treatment and show you the equipment.

You will be asked what you thought about the information in the leaflet and what was discussed with your family. The team will then decide if this treatment will be of benefit to you.

Prior to having the treatment, you will have a pre-operative assessment with the doctor, who can answer any questions you may have.

You will be asked to complete pain assessment questionnaires both prior and after the procedure. This information helps us to determine how beneficial this treatment has been for your chronic pain. You will be asked to keep a written diary of how you have felt during the procedure.

If you have any questions, please contact:

Address: Manchester and Salford Pain Centre, Salford Royal, Stott Lane, Salford, M6 8HD
Telephone: 0161 206 4002
Email: PainReception@nca.nhs.uk

For more information you may want to look at the following resources:

• Reactiv8 patient manual
• Reactiv8 patient brochure
• Reactiv8 MRI card

Websites

The British Pain Society
http://www.britishpainsociety.org/

NICE Clinical Knowledge Summary
https://cks.nice.org.uk/topics/back-pain-low-without- radiculopathy/

NHS Website
https://www.nhs.uk/conditions/back-pain/

Manufacturer of the lumbar multifidus restorative neurostimulator patient information
https://lowbackpainrecovery.com/faq/

Reading

Publications are available from The British Pain Society website
https://www.britishpainsociety.org/british-pain- societypublications/patient-publications/

Living with Pain

• https://www.nhs.uk/live-well/pain/10-ways-to-ease-pain/
• Living Well with Pain and Illness: The Mindful Way to Free Yourself from Suffering (V Burch, 2011)

Please ask your neuromodulation nurse for these resources.