SPINAL CORD STIMULATION (SCS)

trial

 

Contrary to most surgeries, where the patient hopes that the desired results materialize, Spinal Cord Stimulators (SCS) actually allow you to go through a trial period where you get to experience how the device will feel, if you were to have it permanently implanted. This is very similar to buying a car, where you can ìtake it out for a spinî and if you do not like it or if it does not satisfy your needs, then you do not have to buy it. The difference is that with a car, your trial period may be a couple of hours, and with the SCS you will have several days.

 

Spinal cord stimulation may reduce but not cure or eliminate your pain. If spinal cord stimulation works for you, you will experience a tingling sensation instead of pain. Successful SCS therapy generally means a more than 50% reduction in pain, improvement in your ability to function, and hopefully, a decrease in your need for pain medication. Spinal cord stimulation will not eliminate the source of your pain.

 

You have been selected as a candidate because alternative therapies, such as narcotic drugs and surgery have not worked or are not desirable to control your pain.

 

To make spinal cord stimulation possible, an electrode will be implanted into your epidural space around your spinal cord. This will be done through an epidural needle. No incisions are necessary for the trial. The procedure is performed in the operating room, to maintain sterile technique. During the procedure, the physician will change electrode positions, configurations, and settings, until adequate stimulation is obtained. The procedure is performed under fluoroscopy (x-ray), very mild intravenous sedation, and the use of local anesthetics (numbing medicine).

 

During the procedure the electrode will be attached to a power source (the Screener), which creates and delivers a small electrical impulse, which in turn creates an electrical field responsible for the ìscramblingî of the pain conduction in your spinal cord. This should lead to a soothing, tingling sensation over the area where you normally experience your pain. The tingling sensation should actually cover more than just the area where you feel pain.

 

You must be awake and involved during your procedure. You will receive local anesthesia and a mild sedative to reduce discomfort. You will have to tell the physician when the tingling sensation adequately covers your pain sensation. This is very important to the success of your procedure. The morning of the surgery, you should take all of your pain medications, with a small amount of water, just enough to swallow the pills. If taking your medications in this manner makes you go to sleep, avoid taking them and talk to your physician about a medication adjustment, since this should not be happening at all.

 

The procedure is done in the ìSame-Day-Surgeryî facility. After the procedure and a short recovery period, you should be able to go home the same day. While in the recovery area, you will receive instruction on use of the screener and on the care of your incisions. You will then go home to tryout the spinal cord stimulation system for a week.

 

During the trial, try to perform your daily activities as normally as possible. Keep a diary of your pain level (0-10), the amount of medication that you consumed, and any problems or questions that you may have. During this trial, we also want you to turn the device off after a couple of hours of use. Once you turn it off, proceed to record the amount of time that it takes for your pain to come back. Do this twice, once at the beginning of your one week trial, and then again at the end of the week. This will help us determine if you may be a candidate for ìcyclingî, a type of programming that can help us extend the life of your SCS battery. For the trial, you will be using a screener as a power source. This device uses a 9 volt battery that can be purchased at any convenience store. Depending on how much energy is needed to feel the stimulation, the screener may actually go through up to one battery per day. Make sure to have enough available for the trial. This is usually not a problem with the permanent implant.

During the trial, you may adjust the intensity and rate of your stimulation in response to your needs, activities and body positions. Monitor your responses and keep a written record.

 

Do not wet your surgical sites, sponge baths are recommended. After the surgery, keep the area covered with the original dressings for the first 48 hours, then carefully change the dressings every day. When changing dressings, clean the area with alcohol and be careful not to pull on the cables. Keep your surgical sites covered with clean dressing at all times. A small amount of bleeding is expected around the cables, during the first 24 hours. Take your antibiotics to avoid serious complication. Call your physician if you develop any fever, chills, pus or redness. After the 7-10 day trial, you should return to the clinic to have the device removed. Keeping it longer increases the risks of infection.

 

Warning: If your cables were to get tangled and the device pulled out of place during the trial, do not try to push it back in. The electrodes are not attached to your spinal cord, therefore no damage to the nerves should occur if they accidentally are pulled. Unfortunately, it will ruin the trial since the electrode position will no longer be appropriate to cover your pain. Accidentally pulling on the cables will probably be painful since they are held in place by a skin stitch. If accidental dislodgement occurs, just notify the nursing staff or your physician for further instructions.

 

Frequently Asked Questions

 

What is a Dorsal Column Stimulator?
A Dorsal Column, or Spinal Cord, Stimulator is a specialized, computerized, electronic device, which stimulates nerves by tiny electrical impulses via small electrical wires placed on the spinal cord. It is an implantable device designed to withstand the hostile environment of the human body. It works by creating an electrical field around the posterior aspect of the spinal cord (the area of the spine that manages ìsensationî). In turn, this electrical field ìscramblesî the ìpain impulsesî so that by the time they reach the cerebral cortex, they are interpreted as a ìsoothing, tingling sensationî.

 

Am I a candidate for Dorsal Column Stimulator?
Dorsal Column Stimulator is offered to patients with chronic and severe neuropathic pain, who have not responded to other treatment modalities. Neuropathic pain being pain due to damaged nerve tissue.

 

Note:

Before proceeding with the actual implant, a series of steps will have to be taken. You will need to be evaluated by a Medical Psychologist with experience in chronic pain management. Assuming that your psychological profile does not contraindicate the implant therapy, you will then have to undergo a "Spinal Cord Stimulator trial". This trial is design to find out if you have any problems with the device, and how effective it will be in controlling your symptoms.

 

What is the purpose of it?
This device interrupts nerve conduction (such as conduction of pain signals) to brain. The idea is to substitute the pain sensation for a soothing, tingling sensation. The purpose is to allow the patient to perceive less pain and therefore, be more comfortable and productive.

 

How long does the procedure take?
It is done in two stages. In the first stage, temporary wires are placed and an external device is used by the patients to generate electrical current. If this trial is successful in relieving pain, then the permanent device is placed under the skin. Each procedure can take up to 3 hours. Success during the trial is considered to be relief of better than 50% of the pain.

 

How is it actually performed?
The wires are placed under x-ray guidance and a local anesthetic like Novocain is used to numb the skin and deeper tissues. The procedure is performed in the operating room to maintain sterility.

 

Will the procedure hurt?
The procedure involves inserting a needle through skin and deeper tissues (like a "tetanus shot"). So, there is some discomfort involved. However, we numb the skin and deeper tissues with a local anesthetic using a very thin needle prior to inserting the needle. Most of the patients also receive intravenous sedation, which makes the procedure easy to tolerate.

 

Will I be "put out" for this procedure?
No, you will not be ìput to sleepî, the procedure is not done under general anesthesia. The placement of the wires is done under local anesthesia with patients mildly sedated. This is necessary to ensure proper placement of the wires. The amount of sedation given generally depends upon the patient tolerance. For the generator placement, patients are given stronger intravenous sedation.

 

How is the procedure performed?
It is done with the patient lying on the stomach when placing the wires. The patients are monitored with EKG, blood pressure cuff and blood oxygen-monitoring device. The skin is cleaned with antiseptic solution and then the procedure is carried out. X-ray (fluoroscopy) is used to guide the needle for wire placement.

 

Where are the wires inserted?
For the pain involving the low back and lower extremities, the wires are inserted in the midline at the lower back. For the pain involving upper extremities, the wires are inserted in the midline at the upper back.

 

What should I expect after the procedure?
If the procedure is successful, you may feel that your pain may be gone or quite less. You will experience a fairly constant sensation of stimulation. You may have soreness due to the needles used for a day or two.

 

What should I do after the procedure?
This procedure is normally a day-procedure. Some patients may be kept overnight for observation. You should have a ride home. We advise the patients to take it easy for a day or so after the procedure. Perform the activities as tolerated by you.

  

Will the Dorsal Column Spinal Cord Stimulator help me?
It is very difficult to predict if the procedure will indeed help you or not. For that reason temporary wires are placed to determine if this device will be effective to relieve your pain or not. Typically, patients will have a 50 to 70 % reduction in their pain.

 

What are the risks and side effects?
Generally speaking, this procedure is safe. However, with any procedure there are risks, side effects, and possibility of complications. Please discuss your concerns with your physician.

 

Who should not have this procedure?
If you are on a blood thinning medication (e.g. CoumadinÆ), or if you have an active infection going on, you should not have the procedure.

 

Where can I get additional information?
More detailed information is available from the manufacturer of this device. At the time of consultation you will receive a Spinal Cord Stimulation Patient Education Booklet. Additional information is also available at the Medtronicsô Web Site

 

Risks and Complications Associated with Implants

 

What are the risks, side effects, and possible complications?
Generally speaking, most procedures are safe. However, with any procedure there are risks, side effects, and the possibility of complications. The risks and complications are dependent upon the site of the procedure performed. The closer to the spine, the more serious the risks are. Great care is taken to prevent possible problems. Nevertheless, complications can still occur. The following is not meant to be interpreted as a list of all possible problems. Remember that unforeseen complications can occur.

 

1.       Infection: Any time the skin is surgically manipulated there is a risk of infection. Sterile technique and antibiotics are used in an attempt to prevent infections. There are five possible types of infection:

a.       Localized skin infection.

b.       Central Nervous System infection ñ this can be in the form of meningitis, which can be deadly.

c.        Epidural Infections ñ this can be in the form of an epidural abscess, which can cause pressure inside of the spine, causing compression of the spinal cord with subsequent paralysis. This would require an emergency surgery to decompress, and there are no guarantees that the patient would recover from the paralysis.

d.       Discitis ñ this is an infection of the intervertebral discs. It occurs in about 1% of discography procedures. It is difficult to treat and it may lead to surgery.

e.       Osteomyelitis ñ this is a bone infection, very rare, but also very difficult to treat due to poor blood flow to the bones. This may also require surgery to treat.

Note: In the case of implants, infections may require the removal of the implant.

2.       Pain: All surgeries are expected to have a postoperative recovery period where you may hurt more than usual, until the affected tissue heals and recovers.

3.       Damage to internal structures: Nerves and blood vessels can potentially be damaged. Please discuss your specific concerns with your physician.

4.       Bleeding: Bleeding is more common if the patient is taking blood thinners such as aspirin, Coumadin, Ticlid, Plavix, etc., or if he/she have some genetic predisposition such as hemophilia. Bleeding into the spinal canal can cause compression of the spinal cord with subsequent paralysis. This would require an emergency surgery to decompress and there are no guarantees that the patient would recover from the paralysis.

5.       Pneumothorax: Puncturing of a lung is a possibility, every time there is work done in the area of the chest or upper back.

6.       Spinal headaches: They may occur with any procedures in the area of the spine.

7.       Spinal fluid leaks: This may cause a persistent headache or accumulation of fluid in the pocket site. It may require surgery to correct.

8.       Nerve damage: By working so close to the spinal cord, there is always a possibility of nerve damage which could be as serious as a permanent spinal cord injury with paralysis.

9.       Death: Although rare, severe deadly allergic reactions known as ìAnaphylactic Reactionî can occur to any of the medications used.

10.    Worsening of the symptoms: We can always make things worse.

11.    Seromas: This is an accumulation of fluid at the surgical site, most commonly seen at the ìpocket siteî of the implant. It can last several weeks to months, and it may need to be drained several times, until it stops recurring. It also has the potential of getting infected, requiring removal of the Implant.

 

What are the chances of something like this happening?

Chances of any of this occurring are extremely low. By statistics, you have more of a chance of getting killed in a motor vehicle accident, while driving to the Hospital, than any of the above occurring. Nevertheless, you should be aware that they are possibilities.

 

Who should not have this procedure?
If you are on a blood thinning medication (e.g. CoumadinÆ, PlavixÆ, see back), or if you have an active infection going on, you should not have the procedure. If you are taking any blood thinners, please inform your physician.

 

How should I prepare for this procedure?

…       Do not eat or drink anything, at least six hours prior to the procedure.

…       Bring a driver with you. Cannot be a Taxi.

…       Take all of your medicines the morning of the procedure, with just enough water to swallow them. If you have diabetes, do not take your Insulin or your sugar pills (oral hypoglycemics) until after the procedure.

…       Do not take aspirin or any aspirin-containing medications, at least eleven (11) days prior to the procedure. They may prolong bleeding.

…       Do not take any non-steroidal anti-inflammatory drugs, at least one day prior to the procedure. They may prolong bleeding.

…       Wear loose fitting clothing that may be easy to take off and that you would not mind if it got stained with Betadine or blood.

…       Take a shower the morning of the procedure, using a bactericidal soap to minimize chances of infection.

…       Do not wear any jewelry or perfumes.