Have questions? We’ll try to help give you answers. Below, you’ll find answers to common questions about Medtronic spinal cord stimulation (also known as neurostimulation therapy). Don’t see your question here? Ask your doctor, or find a specialist near you who can answer your questions.

General Questions About Spinal Cord Stimulation

Talk to your doctor to determine the kinds of pain treatments that may work for you. The choice of treatment depends on the type of pain, its severity, and your response to your pain treatment. If your doctor thinks you are a good candidate for spinal cord stimulation, you can complete a screening test to see if it will provide adequate pain relief.

The sensation felt from spinal cord stimulation varies from person to person, but most people report a mild tingling sensation in the area of their pain.

Typically, people who find the treatment helpful experience significant and sustained reduction in chronic pain.1 However, spinal cord stimulation does not eliminate the source of pain, so the amount of pain reduction varies from person to person. Neurostimulation therapy is not a cure for chronic pain, but rather a therapy to help you manage your pain.

As you change positions, your spinal cord may move closer to or farther from the electrodes that send out the mild electrical pulses. A therapy level that blocks your pain well when you're standing may cause discomfort when you're lying down. Depending on the neurostimulator you and your doctor choose, you can either adjust the stimulation manually by using your programmer, or your neurostimulator will automatically adjust it for you, using a technology called AdaptiveStim®. AdaptiveStim is available only from Medtronic with the RestoreSensor® neurostimulator. Adaptive stimulation reduces the need to manually adjust your stimulation level when you change positions.

Your spinal cord stimulation system will not provide relief from other types of pain such as headaches, stomachaches, fractures, etc.

No. Spinal cord stimulation was developed by Medtronic and approved by the U.S. Food and Drug Administration in 1984.

Many insurance companies will pay for spinal cord stimulation. However, as with many pain treatments, your doctor will have to get approval from your insurance company before you can receive treatment. Your out-of-pocket costs will vary according to your insurance plan. Consult your doctor or insurance carrier for more specific information.

Medicare will pay 80% of the cost as long as the procedure is determined to be medically necessary. Talk to your doctor about the Medicare Conditions of Coverage.

Questions About the Screening Test for Spinal Cord Stimulation

The procedure to get the screening test takes approximately 30 to 90 minutes. The screening test period lasts approximately 3 to 7 days.

You will have local anesthesia when the leads (thin, insulated medical wires) are placed. There may be some occasional discomfort during the procedure, and you may have pain at the incision site once the anesthesia wears off. This should resolve after a day or so. You should not have pain or discomfort during the rest of the screening test period.

Complications can occur with the screening test and may include infection and movement of the lead within the epidural space. Please discuss the benefits and risks with your doctor.

Your doctor may reduce your dose or have you stop taking oral medication 1 to 2 weeks prior to the test. During the neurostimulation screening test, oral medication may be given for breakthrough pain. Never stop taking your prescribed pain medication without first consulting your doctor.

Your pain relief may differ slightly. For most people, the stimulation they feel at implant is similar to that at the screening test. Your doctor can adjust your neurostimulator so it delivers the best pain relief possible. Be sure to tell your doctor about the way you feel, so changes can be made to optimize your therapy.

If the screening test is successful, you and your doctor will discuss when the system should be implanted. There is typically a waiting period between the screening test and the implant procedure. This will give the incision in your back time to heal and allow time for your insurance provider to be notified and for the surgery to be scheduled.

Questions About Long-Term Spinal Cord Stimulation

Many people experience improvements in their pain symptoms and quality of life after receiving Medtronic spinal cord stimulation. Benefits may include:

  • Significant and sustained reduction in chronic pain1
  • Improved ability to function and participate in activities of daily living1
  • Less oral pain medication needed2

In addition, this treatment:

  • Has been proven to be safe and effective when used as directed
  • Can be adjusted to provide different levels of stimulation for various activities and times of day
  • Lets you try the therapy for a short period of time before you receive a permanent implant
  • Is reversible—the therapy can be turned off or surgically removed

The neurostimulation implant is placed under the skin surgically. So, surgical complications are possible, similar to other surgeries. These may include infection, pain at the site of surgery, and bleeding into the epidural space.

Once the neurostimulation system is implanted, it’s possible that device complications may occur. These include corrective surgery, jolting, lead breaking, and movement of the lead within the epidural space, which may require reprogramming or surgical replacement of the leads. These events may result in uncomfortable stimulation or loss of therapy.

See Important Safety Information for more details. Also, please discuss the benefits and risks of this therapy with your doctor.

The procedure to implant the neurostimulation system takes approximately 1 to 3 hours and may require a brief hospital stay.

Typically, the implant of the neurostimulation system is performed under general anesthesia. However, you may wish to talk with your doctor about other options.

Depending on your doctor’s preference and hospital policy, a hospital stay may be recommended. However, the procedure may be performed on an outpatient basis, which means no overnight stay is required.

The device is about the size of a stopwatch.

The spinal cord stimulator does not make any noise. The device does not normally show through your clothes. It is often implanted in the lower abdomen, where it is most comfortable and least visible. It may be felt as a small bulge under your skin.

You control the spinal cord stimulation with a handheld programmer that works like a remote control to adjust your stimulation within the settings your doctor has selected.

A typical follow-up schedule is once every 6 months, although initially the neurostimulation system may require more frequent adjustments to provide the best pain relief possible.

Yes, it can be turned off or surgically removed, if desired.

When you have an implanted electronic device, you have to be careful about MRI scans. The good news is that MRI scans are possible with Medtronic neurostimulation systems for chronic pain,* with proper safeguards. In fact, only Medtronic offers neurostimulation systems that are FDA-approved for MRI scans anywhere in the body, under specific conditions.

*Excludes Itrel® 3

References

  1. Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized controlled trial in patients with failed back surgery syndrome. Pain. 2007;132:179-188.
  2. Ohnmeiss DD, Rashbaum RF, Bogdanffy GM. Prospective outcome evaluation of spinal cord stimulation in patients with intractable leg pain. Spine. 1996;21:1344-1350.

Wondering what pain doctors have to say about neurostimulation? Below, you’ll find answers to common questions about spinal cord stimulation, from pain management specialists with more than 5 years of experience with Medtronic Chronic Pain Therapies.

The doctors listed on this page are paid by Medtronic as consultants. Medtronic asked for their statements regarding their experience with neurostimulation.

Dr. Grigsby
Dr. Grigsby
Dr. Hesseltine
Dr. Hesseltine
Dr. Provenzano
Dr. Provenzano
Dr. Wellington
Dr. Wellington

Pain Doctors Answer Questions About Spinal Cord Stimulation

Dr. Provenzano says:
Patients may have a fear of having a foreign object inside of them. And I think that’s a legitimate question that should be answered. The reality is that in this country, and also worldwide, there are millions of people with implantable devices—whether it’s pacemakers, total hips, total knees. We know that in a majority of people, this is very suitable and it works out well.

There are responsibilities and there are risks with implanted devices. And it’s important that patients understand those risks. And it’s also important that healthcare providers and patients do everything to responsibly manage an implantable device.

Dr. Grigsby says:
I remind people that there are millions of implantable devices in use. Medtronic performs routine testing to ensure devices are safe to be implanted in your body and most people tolerate them well. There are always risks, but Medtronic and your physician do all they can to reduce those risks. Neurostimulation has been used for more than 30 years and there are continuous advances in the technology and the safety of the devices.

Dr. Grigsby says:
This is more of a concern with drug delivery therapy because the pump is larger than the neurostimulator. There have been great advances in technology and the devices have gotten much smaller than they originally were. In many individuals, it is not very obvious that they have a device because it is so small. We typically place the device below the beltline where it is covered by clothing, making it much less noticeable.

Dr. Hesseltine says:
These devices are designed for patients who have failed the more conservative treatment options. They are not last resort therapies, but they’re also not first line therapies. They are intended for long-term use. You should first try things like massage, physical therapy, chiropractic, acupuncture, medication, and other treatments that are non-invasive and inexpensive. If those approaches don’t work, then consider neurostimulation or drug delivery therapy.

To determine whether to try neurostimulation or drug delivery therapy, we first evaluate the type of pain. Neurostimulation is indicated for nerve-related pain in the extremities or the trunk. For example, this could be an option for a patient who has failed back surgery and has continuing back and/or leg pain. Drug delivery therapy is better for widespread pain. If there is a question as to which therapy to try, I try neurostimulation therapy first.

Dr. Wellington says:
In an appropriately selected individual, the success rates can be very high. At my practice, the success rates are at least 75 percent for spinal cord stimulation. Drug delivery therapy success rates are also very high. In fact, my experience with drug delivery therapy isn’t a question of “Will it work?” It’s a matter of when it works and at what dosage.

The improvement in pain and quality of life with neurostimulation or drug delivery therapy has been dramatic in many people. There have been significant improvements in terms of quality of life and function, ability to work, and participation in family life. With the improved pain control of these advanced therapies, patients are often able to reduce or eliminate their oral pain medications. I will have patients return to the office describing that they have “come out of a fog” when weaned off of their previous oral pain medications. Patients have gone from being homebound to going out to the grocery, mall, or church. Basically, people return to living much fuller lives. It’s very exciting.

Dr. Hesseltine says:
I explain they can test the therapy out and experience it without an incision—just a spinal injection—which is something they have likely already experienced. Patients often hope that another surgery or therapy will come along that will be even better than this option. And so they like the fact that it does not have to be a permanent procedure. The neurostimulator or drug delivery pump can be surgically removed if patients do not like it or if they decide to pursue a different treatment.

I also remind patients that they can talk to someone who is living with neurostimulation or drug delivery therapy before making a decision. The Medtronic Ambassador Program puts people in touch with a volunteer who is living with the therapy and is interested in sharing their experience.

Dr. Wellington says:
Neurostimulation uses low voltage electrical current delivered through electrodes placed in the epidural space. The electrodes are within leads (wires) that are placed through a needle into the epidural space which is just outside of the spinal canal where the spinal cord is located. The normal pain signal pathways in the spinal cord are disrupted by electrical pulses before they reach the brain. This replaces the pain with a vibration or massaging sensation that most people find really soothing. Neurostimulation is like a pacemaker for your spinal cord, instead of for your heart. It is reversible and you have the opportunity to try it through a screening test before implanting the device.

Dr. Provenzano says:
What we want to do with spinal cord stimulation is not only control pain, but also help improve function, so patients can do the things they want to do, every day. Whether it’s walk around the mall. Do more activities with children or grandchildren. Do more things around the house. Or do more things at work.

Dr. Grigsby says:
The specific improvements that we want to achieve include improvements in side effects and complications of chronic illness. So we want to see patients sleeping better. We want to see them use fewer medications. We like to see them have a better exercise tolerance and ability to walk or perform the activities of daily living that are realistic goals for them.

Dr. Provenzano says:
The first thing is that, it may help patients control their pain better. We may not be able to completely eliminate the pain but we want to significantly reduce it. By improving pain control, we help improve function. Another benefit is that stimulation therapy is a reversible treatment—unlike a second or third back surgery, which often involves a major operation. A third benefit is the possibility of lowering the dosage of pain medications. The patient may still need to take some pain medications, but hopefully at lower doses. And by lowering the doses, we hope the side effects will be reduced.

Dr. Wellington says:
The main goal of neurostimulation therapy is to improve your pain control so that you might have an improvement in function and quality of life. By modulating the central nervous system (through the spinal cord) versus the peripheral nervous system, you can often get significantly improved pain relief. Medtronic neurostimulation systems have approval for use with MRI scans.*

Unlike many other treatments, neurostimulation doesn’t require medication. So you don’t have to wait for medications to take effect because the stimulation is instantaneous. There are no drug side effects to manage. Often, patients who have neurostimulation therapy are able to decrease or eliminate their medication use. For some patients who continue to need their medications, combining those medications with neurostimulation may provide better control over their pain. Neurostimulation puts you in complete control of your therapy with a remote control. That means you can adjust your settings throughout the day so you have more pain control when you need it.

*Excludes Itrel® 3

Dr. Provenzano says:
When a patient sits down with his or her physician and is considering a spinal cord stimulation trial and possibly an implant, it’s important to understand the risks associated with the implant. We try to do everything we can to limit those risks, but there are still risks. With a permanent implant, some of the risks are similar to a trial, such as bleeding, infection, and nerve damage. There’s also the possibility of a spinal headache. Once a device has been implanted we have also other concerns. We want to do everything to limit the risk of infection because if this system were to become infected, it would typically be removed.

There’s also the chance that the lead will move, for example if a patient does an activity that puts a lot of stress on the lead that causes it to move. If the lead moves, there’s a possibility that we may not be able to control pain in the area that was really bothering the patient. The first thing we’ll do is try to reprogram the system to see if we can cover that area again. If we can’t, there’s the possibility that we may have to go in back surgically and revise the system and put the lead back in the appropriate position.

Dr. Grigsby says:
There are the risks that accompany any surgical procedure, including infection. If the area becomes infected, the system may have to be removed. There may be pain at the incision site or discomfort where the device is placed. The procedure uses a needle around the spine and, although rare, it could cause spinal cord injury resulting in nerve damage or paralysis. There may be a loss of the stimulation pattern if the lead migrates or moves. If this happens, we can reprogram the system or a surgery may be necessary to revise the system. This device is very reliable, but there is also the possibility of hardware failure, like needing to replace the battery.

Dr. Provenzano says:
What I always tell individuals who are suffering from chronic pain is that unfortunately there may not always be a cure. And so our goal is to reduce the pain to our best ability. But in order for us to do that, patients also have to take an active role in their pain management. With the spinal cord stimulation system, that may mean having to come back and get reprogramming. There may be times that the stimulation is not as enjoyable as it was initially, or it may become bothersome. If that happens, we would work on reprogramming to try to bring back that pleasant sensation the patient initially experienced. If a patient takes an active role in pain management in this way, they’ll get better results with the therapy.

Dr. Provenzano says:
It’s one of the few surgical operations that you actually get to trial before you commit to the permanent implantation. So you don’t have to expect or guess what your results are going to be. You actually get to work with the system and see if it helps improve your function by controlling your pain better. Another benefit of the spinal cord stimulator trial is that it’s a reversible and nondestructive treatment option. The lead is removed at the end of the trial. If the trial did not help improve your pain or function, you do not need to progress forward to the implantation.

Dr. Provenzano says:
Patients who are contemplating whether or not to progress forward with the spinal cord stimulator trial should discuss the risks with their physician. There can be risks including bleeding, infection, nerve damage. There can also be the risk of a spinal headache. We do everything to limit those risks, but patients should be aware of them.

DR. GRIGSBY ANSWERS THE QUESTION

DR. PROVENZANO ANSWERS THE QUESTION

Dr. Provenzano says:
If a patient decides to progress forward with a spinal cord stimulator trial and possibly implant, one of the things that we will ask the patient to do is go for a psychological evaluation. It helps us determine if there is a psychological condition that at this point may require additional treatment before we consider progressing forward with the trial. For example, the patient may have high levels of depression or anxiety that we may be able to help them with before we progress forward to the trial. And the reason we do this is we really want to make sure that the patient can have the best results from this treatment.

Dr. Provenzano says:
At the end of the three- to five-day test, the patient returns to the doctor’s office. We may at that time work with new programming. What I mean by that is we may work on changing some of the stimulation patterns to see if we can further reduce pain. Then we remove the leads, clean off the area where the leads where placed, and cover it with a bandage. At that stage we sit down with the patient and talk about their experience during the screening test. We ask questions such as, Did it help you with pain control? Did it help you with function? Did you find the spinal cord stimulation system pleasant or tolerable? We discuss whether the patient may want to consider going to a permanent implant. There’s no need to make the final decision that day. If a patient needs more time to think about it, that’s appropriate. We answer all the patient’s questions about the permanent implant or any other questions that they might have. And then I think it’s a good time for the patient to go home and to think about whether this is the appropriate therapy for them, and come back to the office again to ask further questions if they have any.

DR. PROVENZANO ANSWERS THE QUESTION

DR. PROVENZANO ANSWERS THE QUESTION

Dr. Provenzano says:
We’ve had such major advancements in the technology of spinal cord stimulation. The batteries have gotten much smaller. Because they’re smaller, they’re not often very apparent. In addition, we often implant these devices in areas that may be covered by clothing. So they would be even less visible.