SPINAL CORD STIMULATION


From Advanced Neuromodulation Systems



Coping with chronic pain is one of life's greatest challenges. While you struggle with simple daily tasks, those around you struggle to understand just how much you hurt and why your pain doesn't get better. In time, pain can overwhelm every aspect of your life. It can also take away hope that you will recover and can greatly decrease the quality of life for you and your loved ones.

Many people with chronic pain suffer needlessly for years. Some believe that nothing can be done for their pain. Others are too weary, frustrated, or embarrassed to discuss the extent of their pain with their doctor.

The good news is that there are treatment options to help you challenge your pain and improve your quality of life.



The Basics of Spinal Cord Stimulation


SCS: An Advanced Therapy for Pain

Spinal cord stimulation (SCS) is an advanced therapy for certain types of chronic pain and is actually part of a broad category of medical therapies known as neuromodulation. Although it is not a cure, SCS can be successful in treating the pain associated with a host of chronic pain syndromes. Over the last 20 years, thousands of people with severe chronic pain have received pain relief with spinal cord stimulation.

SCS uses a small implanted device—called a pulse generator or receiver—to generate low-level electrical impulses that stimulate targeted nerves along the spinal cord. This stimulation interferes with the transmission of pain signals to the brain. When successful, SCS replaces painful sensations with a more pleasing tingling sensation called paresthesia.


Types of SCS Systems

To understand how spinal cord stimulation works, it is helpful to understand the two types of SCS systems and their different components.

The first type of system is an implantable pulse generator (IPG). An IPG's power source consists of a battery and related electronics that are housed in a single metal container. The IPG is completely implanted under the skin. Leads are placed over the spinal cord and connected to the IPG. It is important to note that from time to time a surgical procedure is performed to replace the IPG with a new one because the battery has become depleted.

The second type of system is the radio frequency (RF) spinal cord stimulator. RF spinal cord stimulators are similar to IPGs except the battery that supplies the power is a rechargeable, cell-phone type battery that is located outside the body, contained in a small controller called a transmitter. The transmitter delivers radio waves through the skin to an implanted receiver. The receiver in turn sends the mild electrical energy to the leads.


How SCS Works

The components of the SCS system are implanted during a surgical procedure, which, depending on the type of leads used, can be brief and minimally invasive. During this procedure, the lead or leads are positioned in the epidural space above the spinal cord; the IPG or receiver is placed just under the skin in a practical location that is acceptable to you and your doctor; and the leads are connected to the IPG or receiver.

When the power source is turned on, the electrodes on the leads stimulate the specific nerve fibers that affect the painful areas. The stimulation of these targeted nerves is intended to change how the brain perceives the pain signals.

Who SCS Can Help

Spinal cord stimulation is not a treatment option for everyone. It is used to treat chronic pain of the trunk and/or limbs. SCS is most effective in relieving persistent or severe neuropathic pain—the type of pain that results from injury to nerves. Neuropathic pain is often described as an intense burning or stabbing pain. It can be very stubborn and disabling since it does not respond effectively to many standard therapies.

Additionally, SCS is considered an advanced pain treatment, which means that SCS is generally not considered an option until more conservative, less invasive and/or less expensive pain therapies have been tried and have failed to adequately control your pain. These therapies include bed rest, over-the-counter pain relievers, NSAIDs, nerve blocks, opioids and, perhaps, corrective surgery.

A number of other factors also affect whether you are a good candidate for SCS. These include your diagnosis and medical history, as well as the severity, location, and type of pain. Successful SCS therapy also requires that you be a willing partner in the therapy. An open and honest dialogue with your doctor and your family will help you to determine if SCS is an option for you.



Frequently Asked Questions About Spinal Cord Stimulation


Is spinal cord stimulation safe?

Thousands of people worldwide have used spinal cord stimulation successfully over the last two decades. SCS has been cleared by the FDA for the treatment of certain types of chronic pain, including pain of the arm(s), leg(s), and/or trunk, and it has received approval for distribution internationally through various governmental authorities.

Will I be totally pain-free with spinal cord stimulation?

Spinal cord stimulation is not a cure, so it is unlikely that SCS will eliminate all of your pain. The goal with SCS is to decrease your severe chronic pain to the point where you can increase your participation in daily activities. The degree of pain relief varies from person to person. While many patients report a significant reduction in pain, most patients say that SCS reduces their pain by 50 percent or more.

Will spinal cord stimulation allow me to be free of pain medicines?

Spinal cord stimulation is part of an overall treatment plan to manage chronic pain. While many SCS patients are able to decrease or even discontinue pain medication, your pain may increase occasionally, and you may need pain medication in addition to spinal cord stimulation.

Is spinal cord stimulation similar to Transcutaneous Electrical Stimulation (TENS)?

Both TENS and SCS use electrical impulses, but they are very different in how they work and the types of pain that they can treat effectively. A TENS unit is an external device. It delivers electrical impulses through pads placed directly on the skin over the painful site. TENS stimulation is weaker and more localized than spinal cord stimulation. TENS is generally not effective for severe chronic pain. Past success or failure with TENS therapy is not an indication of how you will respond to spinal cord stimulation therapy.

Will spinal cord stimulation work for me?

Spinal cord stimulation is most effective for treating chronic neuropathic pain (pain that originates in the nerves or nervous system). In addition to an appropriate diagnosis, certain physical and psychological factors make some patients better candidates for SCS therapy than others. Your doctor will carefully evaluate your medical history before prescribing spinal cord stimulation. Your commitment to the treatment's success is also important. To get the greatest benefit from spinal cord stimulation, you must be a willing partner in this treatment. You will need to take the time to understand how the stimulator works and strictly follow your doctor's orders regarding its use.



The SCS Trial

One of the most important factors in your long-term success with spinal cord stimulation is the SCS trial. During the SCS trial, a lead or leads are implanted on a temporary basis to help determine if the therapy will work for you.

The SCS trial allows you to

  1. Decide if spinal cord stimulation therapy is effective for the type, location and severity of your chronic pain
  2. Evaluate the effectiveness of various stimulation settings and programs
  3. Help decide what type system (IPG or RF) will provide the greatest possible level of pain relief


The Trial Procedure

The SCS trial usually requires only a short, minimally invasive surgical procedure. The procedure is often performed on an outpatient basis or at a day surgery center.

During the procedure, one or more leads are placed in the epidural space above the spinal cord. The lead(s) is inserted through a small needle called an epidural needle or through a small incision. The exact placement of the lead(s) depends upon the location of your pain.

When the lead(s) is positioned in the optimal location, it is connected to an external device and activated. This external device will be programmed to generate low-level electrical impulse to replace your areas of intense pain with a more pleasant sensation known as paresthesia.

During the trial implantation, you may be placed under general anesthesia or under light sedation with a local anesthetic to numb the area where the lead(s) is inserted. Light sedation allows you to be awake to answer questions when the trial stimulator is activated and to help your doctor determine how well the stimulation covers your pain pattern.

When you and your doctor determine that the lead(s) will provide adequate stimulation in the areas that hurt, the incision is closed and a sterile dressing is applied. However, some doctors decide, based on their experience, that this initial trial in the operating room is adequate, and they implant the spinal cord stimulator permanently at this time.


After the Trial Procedure

Before you leave the hospital or surgery center, you will learn how to use the trial stimulator, how to care for your incision, and what restrictions you are to follow. You may be encouraged to resume light activities, such as walking, during the trial period to test the effectiveness of the stimulator.

Several days or more after the surgery, you may be instructed to return to your doctor's office for a follow-up visit, or a nurse may phone you to see how you are doing. During the trial period, most patients have questions about how to use the stimulator; so don't be shy about asking for help. Your health care team expects you to have questions and will be glad to assist you.

Your Role in the Trial Stimulation

You have a very important role during the trial period. You will need to follow your doctor's instructions, be a careful observer, and take good notes. Some doctors provide a trial diary for just this purpose.

You should use the trial period to learn as you can. For example, observe how your pain pattern and location change throughout the day and the degree of relief that the stimulation prescription(s) provides.

When the Trial Period Ends

At the end of the trial period, you will meet with your doctor to discuss the effectiveness of the therapy. If your pain has decreased by 50 percent or more, the treatment is usually considered successful. If you decide to have the SCS system implanted permanently, your doctor will schedule another procedure to implant the permanent system components.

If the stimulator is not providing sufficient pain relief, your doctor may re-program the system and extend the trial period; or you may decide to have the lead(s) removed and explore other treatment options.

Frequently Asked Questions About the SCS Trial


Is a trial implantation really necessary?

Undergoing trial stimulation before you commit to a full SCS system implantation is a good idea for two reasons. First, if it is carefully planned and conducted, a trial gives you and your doctor valuable information for determining which system is best for you. Second, many health insurance plans require a trial in order to qualify the system as a covered benefit.

What are the possible complications with the surgery?

As with any surgical procedure, a risk of infection and bleeding exists, as does the possibility of injury to the spinal cord, lead failure, or lack of benefit from the therapy. The risk of complications is low, and your doctor will discuss possible complications with you.

How long does the trial last?

Your doctor will determine the length of the trial. It may last for only a few minutes in the operating room, or you may try the system for several days or several weeks. A longer trial may allow you to test how well the spinal cord stimulator responds to the different types of pain you experience throughout the day and during various activities. A shorter trial may be appropriate if your response is immediate and pain relief is dramatic. What is important is that you have a chance to see if SCS provides adequate pain relief.

The SCS Implantation

If the spinal cord stimulation trial provides adequate pain relief, you will return to the operating room to have the system implanted permanently.

The Surgical Procedure

Like the trial implantation, the permanent implantation requires a surgical procedure. Depending on the type of lead chosen, this procedure can be relatively short and minimally invasive and is often performed on an outpatient basis or at a day surgery clinic. Your doctor will discuss with you the type of anesthesia he or she feels is appropriate given the type of system being implanted.

Once you are comfortable, the components of the SCS system are implanted. Depending upon whether you are receiving an IPG or RF system, the implantable pulse generator or RF receiver is implanted.

If a temporary lead(s) was used during the trial and is still implanted, your physician will remove it. Next, the permanent lead(s) is tunneled through the subcutaneous (soft) tissue and attached to the IPG or receiver. The IPG or receiver is implanted in a location that you and your doctor have decided is a practical and acceptable. Then the incisions are closed and a sterile dressing is applied.

After the Procedure

Most patients are sent home the same day; however, your doctor will decide if a longer hospital stay is required for your specific circumstances. Before you are released from the hospital or day surgery unit, you will learn how to care for your incisions and about restrictions to your physical activities, and you will make a follow-up appointment to visit with your doctor.

Depending on your doctor's preference, your stimulation may not be started until your follow-up appointment. Your follow-up appointment is usually scheduled for several days or more after surgery. This gives your incisions time to heal. During this appointment, the stimulator will be turned on and programmed with the stimulation settings that provide you with the greatest pain relief.

Your doctor or a member of his or her staff will teach you how to use and care for your stimulator. You will learn how to adjust the stimulation to the level you need to remain as pain-free as possible throughout the day. You will also have plenty of opportunity to ask questions about living with your SCS system.


Frequently Asked Questions About the SCS Implantation


What can I do to improve my chances for success with spinal cord stimulation?

Success requires a team effort. Your doctor and/or his or her staff will program your spinal cord stimulator and teach you how to use it. But from that point forward, success depends on you and your willingness to participate fully in your therapy.

You can start by asking your doctor the following:

  1. What can I do to improve my chances for success?
  2. How long will it take to heal after surgery?
  3. What physical activities must I avoid? For how long?
  4. How often will I return for follow-up visits?
  5. When can I resume previously abandoned interests and activities?
  6. Can I return to work?
  7. What have other patients done during their recovery and beyond that made a difference in their outcomes?
Taking charge of your therapy will improve your recovery and, perhaps, your quality of life.

Is the implanted device noticeable?

It depends on your body shape and size and where the implant is located. Some patients can see the outline of the device through their skin; however, most patients say it is easy to forget that the implanted device is there.

Can I actually control the stimulation therapy?

Yes. You will control your treatment with the programmer (IPG system) or transmitter (RF system). The programmer or transmitter lets you turn the stimulator on and off. In some cases, it also allows you to adjust the intensity of the stimulation to provide sustained pain relief throughout the day.

How long will it take before I feel better?

Recovery times vary among patients, but incisional pain usually subsides in 10-14 days. Many patients say that spinal cord stimulation makes a noticeable difference in controlling their pain from the time it is first turned on.

Are there possible complications with spinal cord stimulation?

SCS is a pain therapy with a low risk of complications. These include the loss of effective stimulation due to movement of the leads, loss of stimulation coverage due to equipment failure, movement of the stimulation coverage, over-stimulation, loss of the pain-relieving effect, or an allergic reaction to the system components. The effect of spinal cord stimulation therapy on pregnancy and nursing mothers has not been studied. You should discuss risk factors and your concerns with your doctor.

Living with Your Spinal Cord Stimulator

The weeks following the implantation of your spinal cord stimulator can be an exciting time. You will be learning about the therapy and starting to take control of your chronic pain. Gradually, you will begin to do more of the things that you want to do. Most patients find that living with a spinal cord stimulator requires no extra time or effort in their life—and this is the first step toward recovery and a healthier, more active lifestyle.


Frequently Asked Questions About Daily Living with SCS


Do I use the stimulator 24 hours a day?

You can use your spinal cord stimulation (SCS) system around the clock if necessary. Most patients get pain relief during the day and turn off the system before bedtime because there can be a “residual” or carry-over effect of pain relief. Other patients use their systems while sleeping. You and your doctor can determine the best schedule to control your pain.

Can I shower or swim with the stimulator?

Yes. However, if you have an RF system, you'll first have to remove the antenna and transmitter.

Is it safe to use household appliances or cellular equipment with my stimulator?

Yes. It is safe to use cellular phones, pagers, computers, and standard household appliances, including microwave ovens, with your system. Department store or airport security gates or theft detectors may cause an increase or decrease in stimulation while you pass through the device. This sensation is temporary and should not harm your system. However, as a precaution, you should turn the system off before passing through these and similar devices.

Can I drive with the stimulator turned on?

No. You should not use your spinal cord stimulator while operating a motor vehicle or other heavy equipment. If you are driving, you will need to turn the stimulator off. However, if you are riding as a passenger, you can leave the stimulator on.

Will spinal cord stimulation allow me to return to work?

Your doctor will help you make this decision. Some patients, depending upon their condition and occupation, are able to return to work while using spinal cord stimulation. However, returning to work should be a goal you and your doctor set, not a requirement for successful therapy.

Can I travel with the stimulator?

Yes. Metal detectors and anti-theft devices may detect your spinal cord stimulation system, but you will receive a patient identification card that will help you clear through these checkpoints. Thousands of people have implanted medical devices, such as pacemakers, so the security personnel will know what to do. When flying, patients with RF spinal cord stimulators must follow the flight crew's instructions and turn their transmitters off for take-off and landing.




For more information on spinal cord stimulation visit www.ans-medical.com.






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