Implanted Neuromodulation Devices (IND) – Trial/Permanent
Why am I having a trial with an IND?
Managing persistent pain with the use of electrical current has been a recognised form of treatment for many years. Common types of pain that may benefit from this treatment include back and leg pain following surgery, vascular pain, neuropathic (nerve) pain and complex regional pain syndromes. However, it is important to remember that as with any procedures for pain management, not everyone benefits. An IND helps some people more than others which is why we initially offer a trial procedure.
How is the procedure performed and does it hurt?
The trial procedure is performed in the operating theatre using sedation.
Before the procedure starts your Anaesthetist will place a small needle (cannula) into a vein in your hand or arm so that sedation can be given. The procedure is performed while you are lying face down and supports (such as pillows) will be positioned for your comfort. Once the area has been cleaned with antiseptic solution your back will be covered with sterile drapes. Local anaesthetic is injected to make the skin area numb. An x-ray machine is used to help guide the electrodes into the right place.. Once the electrodes are in the right area, they will be secured into place with stitches and covered with adhesive padding and dressings.
The length of the procedure varies but you can expect to be in the operating theatre for 45 -60 minutes during the trial procedure and 90- 120 minutes during the permanent 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 done 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 technician from the neuromodulation company and then you will be able to be discharged from the hospital.
What to do over the trial period?
The trial period will usually run over 8-15 days. During this time we will be in contact with you regularly to monitor your progress. You may experience some mild soreness and bruising where the electrodes have entered your skin. This should only last a couple of days. It is important that you remain active during the trial period while being mindful of the activity restrictions.
The equipment
The team at Interventus work closely with the medical device company that supplies the equipment for IND. A representative from the company will be present to provide advice before, during and after the procedure. You will be given their contact details should you have any device related questions.
Activity restrictions during the trial
For the trial to be successful it is crucial that you adhere to the activity restrictions to ensure the electrodes don’t move. These are:
- Roll onto your side when getting in and out of bed
- NO showering while the electrodes are in place
- NO Bending below your knees
- NO twisting
- DO NOT over reach (such as reaching for your mobile phone on a bedside table)
- DO NOT reach above shoulder level, twist, stretch or pull
- DO NOT slouch when sitting
- DO NOT raise the head of the bed more than 30 degrees (that is more than approximately 3 pillows)
- DO NOT lie face down while the electrodes are in place
- Avoid high intensity activity or high impact sports
- Avoid any heavy lifting, greater than 3kg
Proceeding to a permanent implant – early considerations
If you have a successful trial and decide to go ahead with the permanent implant you will be required to have some skin swabs taken to determine if you have any skin organisms that will require treatment before the implant procedure. You will be contacted only if you need to undergo any treatment.
The activity restrictions listed above apply for 8-12 weeks following the implant of a permanent device. This means you may need to reorganize your home life to avoid activities such as hanging out the washing, bending to retrieve pots and pans in the kitchen, vacuuming and mowing the grass.
Following a permanent IND implantation your therapy will not be turned on for approximately ten days. A review appointment will be arranged for you at this time. It is important to keep your wound dressings dry. Your therapy will be activated and your wound dressing will be taken off and staples will be removed from your wounds at your review appointment
There are precautions, dependent on the type of IND that you have, with certain medical devices such as diathermy and MRI. Your device representative can advise you of specific precautions associated with medical equipment.
If you are undergoing a medical procedure with an IND it is important to either turn your device off or put it into “Surgery Mode”, depending on the particular device that you have implanted.
You must avoid welding with an IND as the device can be permanently damaged by this equipment.
Sometimes, people report a temporary interference with stimulation from theft detectors or security systems such as found in airports or department stores. This does not place you in any danger or restrict travelling or shopping, it is just something you need to be aware of.
You will be provided with an Identification Card that you can show airport security. Usually, security will perform a manual body check. If you are required to pass through the security screening, please ensure that you have your remote control with you. Turn your therapy off before passing through the security screening and turn it back on once you have done so.
With particular settings on the IND you will be advised to turn the stimulator off while driving a motor vehicle or operating machinery.
Finally, you will need to return to the pain clinic anytime the device needs reprogramming in addition to regular review appointments.
What are the risks during and after the procedure?
All 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, hospitalization, antibiotic treatment, and/or additional surgery.
Risks related to the surgery include:
- 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
- Epidural haemorrhage
- Haematoma
- Nerve damage
- Spinal cord compression/injury
- Very rarely paralysis
- Extremely rare, death
Removal of the implant might be required in the event of the aforementioned complications.
Preparing for your procedure
Please advise your pain specialist at least two weeks before your procedure if you:
- Are taking blood thinners including fish oils, aspirin or turmeric
- Are a 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
Please ensure you do not drive or make important decisions for the first 24 hours following your procedure.
Day of procedure
- No food within 6 hours prior to your procedure. However, you may take water up to 2 hours prior, 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 to discuss the activity restrictions with you. If you return to the ward after 5pm they will see you the following morning.
After discharge, if you notice:
- Swelling
- Bleeding from the site
- Changes in sensation
- Difficulty with movement of arms of legs
- New symptoms or difficulty passing urine
Please contact Interventus Pain Specialists during office hours, your general practitioner or your nearest Emergency Department after hours.
What happens next?
You will need to return to the clinic to determine if the pain relief provided by the IND was meaningful. This information will help us to guide you with planning a future treatment plan for the management of your pain.
Our entire team is focused on your recovery
Our three highly qualified Pain Specialists are proud to lead an outstanding professional team, including a Pain Nurse, a Pain Psychologist, specialist Pain Physiotherapists and skilled Administrators.
Important patient information:
MEDICAL QUESTIONNAIRE
Once an appointment has been made for you we will ask you to complete a Pain Questionnaire – this is to be completed prior to your consultation with the Doctor, so that we can offer you the best possible care.
PAIN MANAGEMENT PROGRAM
As an Interventus patient, we can facilitate referral to a Pain Management Program.
ABOUT YOUR APPOINTMENT
Key information about what to do prior to your appointment and what happens during the first consultation.
FEES & PAYMENT INFORMATION
Ensure you’re up to date about our fees and payment policy for consultations and procedures.
Find out how Interventus Pain Specialists can help diagnose, treat and manage your specific pain conditions.