Implanted Neuromodulation Devices

Everything you’d like to know about having Implanted Neuromodulation Devices to manage your pain.

Interventus Pain Specialists conducts both trial and permanent Implanted Neuromodulation Devices (IND) to help manage a range of persistent pain issues in our patients. Find out about how the procedures are performed, the benefits and risks, and what you can expect when you come to hospital.

Why do I need an IND trial?

The use of electrical current in managing persistent pain has been a recognised form of treatment for many years. In particular, it may benefit back and leg pain following surgery, vascular pain, neuropathic (nerve) pain and complex regional pain syndromes. It’s important to note that this procedure may not benefit everyone, which is why we recommend a trial procedure before assessing whether a permanent IND may be appropriate.

How is the trial or permanent procedure performed?

• Both the trial and permanent procedures are performed in the operating theatre using sedation
• You will be comfortably positioned lying face down with pillow supports under your legs and chest
• Before the procedure starts, a small needle (cannula) will be inserted into your hand or arm so that sedation can be administered as necessary
• The area to be treated will be cleaned with antiseptic solution and then covered with sterile drapes
• Local anaesthetic will be injected to make the skin area numb and you may feel a sharp sting
• An X-ray machine is used to help guide the electrodes to the right place and when your Interventus Pain Specialist is happy with their location, they will be secured with stitches and covered with adhesive padding and dressings
• The trial procedure may take between 45 – 60 minutes, and the permanent procedure may take between 90 – 120 minutes
• After either procedure, you will be monitored in the recovery area before being transferred back to the ward where you will remain overnight
• An X-ray will be taken on the day of the procedure to check the position of the electrodes
• The following morning, you will be reviewed by the practice nurse and the technician from the neuromodulation company, and if approved for discharge, you will be allowed to go home

What happens over the trial period?

• The trial period will usually runs over 8-10 days
• We will be in regular contact with you during this time to monitor your progress
• You may experience some mild soreness and bruising where the electrodes have entered your skin, but this should only last a couple of days
• It’s important that you remain active during the trial period, but please adhere to the activity restrictions outlined below

What equipment is used?

• Interventus works closely with the medical device company that supplies the equipment for IND
• A representative from this company will be present before, during and after the procedure to provide advice
• Contact details for this company will be provided to you in case you have any device-related questions

What are the activity restrictions during the trial?

In order for the trial to be successful, it is crucial that you adhere to the following activity restrictions to ensure the electrodes don’t move:

• Get in and out of bed only be rolling onto your side
• NO showering while the electrodes are in place
• NO bending below your knees
• NO twisting
• NO overreaching (e.g. reaching for your mobile phone on a bedside table)
• NO reaching above shoulder level, twist, stretch or pull
• NO slouching when sitting
• NO raising the head of the bed more than 30 degrees (or more than approximately 3 pillows)
• NO lying face down
• Avoid high intensity activity or high-impact sports
• Avoid lifting anything heavier than 3kg

What happens if I proceed to a permanent IND?

• If your trial is successful and you decide proceed with a permanent implant, you’ll first need to have some skin swabs taken to determine if you have any skin organisms that will require treatment before the permanent implant procedure
• We will contact you with further advice if you do need to undergo any treatment
• You will need to adhere to the activity restrictions listed above for 8-12 weeks after the implant of a permanent device
• Please consider your home life situation and put alternative arrangements in place so that you can avoid normal activities such as hanging out laundry, bending or reaching to retrieve items, vacuuming and mowing the grass etc
• Depending on the type of IND, there are precautions with certain medical devices such as diathermy and MRI, which your device representative will discuss with you
• You must not use a welding machine while you have an IND as this can permanently damage your device
• Occasionally, a temporary interference can occur with stimulation from theft detectors or security systems found in airports or department stores, however, this poses no risk to your or your device
• With particular settings on the IND, you will be advised to turn the stimulator off while driving a motor vehicle or operating machinery
• You will need to return to Interventus Pain Specialists for your regular review appointments, and any time the device needs reprogramming

Are there any risks?

All medical procedures carry a risk of side effects and possible complications. It is important you are aware of the risks for this procedure as they may require a further procedure, hospitalisation, antibiotic treatment, and/or additional surgery.

Risks related to the surgery include:

• Epidural haemorrhage or infection, leading to spinal cord compression and/or paralysis
• Cerebrospinal fluid leak and headache which may require treatment by another epidural injection on a separate occasion
• Seroma (fluid collection) at the implant site
• Infection
• Lead and equipment migration or breakage
• Undesirable stimulation or loss of beneficial stimulation
• Allergic reaction to implanted material
• Persistent pain at site of implant
• Battery failure

Any of the above complications may result in removal of the implant.

How do I prepare for my procedure?

At least two weeks before your procedure, inform your Interventus Pain Specialist if you:

• Are taking blood thinners, including fish oils, turmeric or aspirin
• Are diabetic
• May possibly be pregnant
• Are allergic to iodine, betadine, chlorhexidine, shellfish, local anaesthetics or steroids
• Have a temperature, feel unwell or possibly have an infection

You must not drive a vehicle or make important decisions for 24 hours following your procedure.

What happens on the day of my procedure?

• Please have no food within 6 hours prior to your procedure
• You may drink water up to 2 hours prior to your procedure, but no more that 200mls per hour
• Take your regular medication with a small sip of water
• Shower the morning of your procedure
• Once you return to the ward, a member of the physiotherapy team will visit you to discuss the activity restrictions. If you return to the ward after 5pm, they will see you the following morning before you are discharged.

After discharge, if you notice:

• Swelling
• Bleeding from the injection site
• Changes in sensation
• Difficulty moving your arms or legs
• Any new symptoms
• Difficulty passing urine

Please contact Interventus Pain Specialists during office hours, your GP or present to your nearest Emergency Department.

What happens next?

• Please call Interventus Pain Specialists to make a follow-up appointment
• Your Pain Specialist will determine the effectiveness of the procedure and develop a tailored and comprehensive pain management plan