Doctors Answer Your Questions

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. 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. 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. Research shows that neurostimulation provides a drop in pain scores and an improvement in quality of life.¹

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.

Medtronic neurostimulation systems have approval for use with MRI head scans.*

*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:
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. Wellington says:
Intrathecal drug delivery therapy requires significantly lower doses of medication. It’s a 300:1 ratio, meaning that if you are taking 300 mg of oral morphine, you need only 1 mg with intrathecal drug delivery therapy. These comparatively low doses of pain medication can yield large effects to improve pain because the medication goes straight to the pain receptors on the spinal cord. Oral opioids often cause many bothersome side effects, but with intrathecal drug delivery’s lower dosages, you can often avoid those side effects. Another benefit is that the pump is programmable. This allows customizing the pump to treat pain, even if it changes. Additionally, the pump can be programmed by a pain physician to allow administration of extra doses of pain medicine for different times of the day when activities may increase your pain. This allows patients to have control for when the pain gets worse. Also, SynchroMed^® infusion pumps are MRI compatible for body scans.

Dr. Provenzano says:
During the screening test, we watch for side effects of the medication, in case the patient is underdosed or overdosed with the medication. We monitor oxygen levels and heart rates for signs or symptoms suggestive of a possible complication. Under- and over-dosing can also occur during long-term therapy. Other risks associated with the screening test and long-term procedure, include bleeding, infection, and nerve damage. There is always the risk of spinal headache because we’ve entered the spinal canal with a needle. In addition, with the long-term procedure, pump or catheter problems can occur and may require corrective surgery.Dr. Hesseltine says:
As with any surgical procedure, there are risks including infection. If the area becomes infected, the system may have to be removed. You may experience pain with the incision or discomfort where the device is placed. The procedure uses a needle around the spine, which could cause spinal cord injury resulting in nerve damage or paralysis. This is rare, but it is a risk. There is the risk of a granuloma or inflammatory mass growing around the tip of the catheter. That mass could push up against the spinal cord leading to emergency surgery or even paralysis. This device is very reliable, but there is also the possibility of hardware failure.

Dr. Provenzano says:
At the end of the screening test we will talk with the patient about their experience. We’ll ask questions such as, Did it help your pain? Did it help you function? Were there side effects that were bothersome to you? And once we have discussed this and answered the patient’s questions, we’ll remove the catheter if the screening test used a continuous catheter system. We will then clean the area where the catheter was inserted and cover it with a bandage.One of the very nice things about a drug delivery trial is that patients don’t have to rush forward right to the implant. We discuss the results and give the patient some time to think about the results. We always give patients the opportunity to ask more questions. If a patient feels that this was an appropriate and helpful treatment, then at that point we will discuss the possibility of progressing forward and doing the implantation procedure.

Dr. Provenzano says:
One of the things that you might be asking is what can I expect with an implantable drug delivery system. Well our goal is to reduce your pain, reduce side effects, and help you with the activities that you desire. But one of the expectations that you clearly have to have with most chronic pain treatments is that this is not a complete cure. It’s a way for us to reduce pain and help you function better.Once we have implanted an intrathecal drug delivery system we will have to work with you to find out what the correct dose is of drug that we should be delivering. So during that time stage you need to be patient. And you need to let us help you in finding the appropriate dose for you.