General Questions About Targeted Drug Delivery

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 targeted drug delivery, you could have a screening trial to see if the therapy will provide adequate pain relief.

Many people experience significant improvement in their pain symptoms and quality of life after receiving Medtronic targeted drug delivery. However, realistic expectations are essential to being satisfied with any pain treatment. Targeted drug delivery does not eliminate the source of the pain, so the amount of pain relief varies from person to person. Targeted drug delivery is not a cure for chronic pain, but rather a therapy to help you manage your pain.

Your targeted drug delivery system will not provide relief from other types of pain such as headaches, stomachaches, fractures, etc.

Questions About the Screening Trial for Targeted Drug Delivery

This will vary depending on the type of screening trial your doctor believes will be best for you. The trial could take as little as a day, and up to several weeks. Depending on the type of screening trial, you may undergo a procedure that takes approximately 1 to 2 hours and then need to stay in the hospital to be monitored after the procedure. Talk with your doctor to understand the details of the type of screening trial that your doctor thinks would be best for you.

Complications can occur with the screening trial, including bleeding, infection, and drug side effects. The catheter may need to be replaced. You should not undergo a screening trial if you have an active infection at the time of the trial, have a body size too small to accommodate an implanted pump, or if you are allergic to the screening medication.

This depends on your pain level and your doctor. Your doctor may withdraw oral pain medications 1 or 2 weeks prior to the screening trial. However, you may be given oral medication during the screening trial for breakthrough pain. Never change the way you take your prescribed pain medication without first consulting your doctor.

Your pain relief may differ slightly. During the recovery period your doctor will slowly adjust the medication dose so you receive the best pain relief possible. This is because the medication dose may be different than the dose used during the screening trial. Be sure to tell your doctor about the way you feel, so changes can be made to optimise your therapy. It may take some time to find the dose that works well to manage your pain – this is called “titrating” the dose, and is a very normal process.

If the trial is successful, you and your doctor will discuss when the system should be implanted.

Questions About Long-term Targeted Drug Delivery

The benefits of Medtronic targeted drug delivery can be life changing. Generally, people experience improvements in their pain symptoms and quality of life after receiving Medtronic targeted drug delivery.1,2 Benefits may include:

  • Significant (50% or greater) and sustained reduction in pain1-3
  • Improved ability to function and take part in daily activities1,2
  • Less oral pain medication1,2
  • Relatively low level of complications when used as directed1

In addition, this treatment:

  • Has been proven to be safe and effective when used as directed
  • Does not involve permanent changes to the spinal cord or nerves
  • Can be adjusted to dispense medication according to your activity level and needs
  • Lets you try the therapy for a short period of time to give you a reasonable idea what your results might be before you receive a permanent implant
  • Is reversible — the therapy can be turned off or the drug pump system can be surgically removed

The implanted pump and catheter are surgically placed under the skin. Surgical complications are possible and include infection, spinal fluid leak, and headache. You should not undergo the implant procedure if you have an active infection at the time scheduled for implant.

Once the infusion system is implanted, device complications may occur which may require surgery to resolve. Drug overdose or underdose can result because of these complications and have serious and even life-threatening adverse effects. Possible complications include the catheter or pump moving within the body or wearing through the skin. The catheter could leak, tear, kink, or become disconnected. The pump could stop because the battery has run out or because of a failure of another part of the infusion system. Additionally, inflammatory mass has been reported at the tip of the catheter which may lead to complications, including paralysis.

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

On average, the procedure takes about 1 to 3 hours from start to finish. Talk with your doctor about the specifics and duration of your procedure.

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

Every patient is different, and depending on your doctor’s preference, a hospital stay may be recommended.

Usually not. The incision needs to be made where the pump will be implanted to help properly anchor the pump. Proper anchoring helps keep the drug pump in place. This may help minimize your discomfort and speed recovery.

That depends on your specific condition(s) and the results you received from the trial. Your doctor will advise you of the recommended catheter location.

In some cases, you may experience a spinal headache as a result of a needle or catheter being placed in the intrathecal space. A spinal headache is caused when cerebrospinal fluid (the fluid that surrounds the spinal cord) leaks out of the intrathecal space. The headache may correct itself, or the doctor may treat it.

You will begin receiving treatment as soon as your pump is filled with medication and the medication is delivered through the catheter to the specific site. However, depending on your medication, it may take several days to weeks before you experience benefits from your medication. During this transition period, your doctor may reduce or eliminate your other medication.

The medication in your pump needs to be refilled every 6 to 26 weeks (180 days), depending on your specific medication, dosage, and size of your drug pump. It is refilled by a needle injection. During these appointments your doctor can adjust your dose of medication to address your pain relief needs.

Yes. After implantation, your doctor can make changes in dosage requirements.

You should discuss this with your doctor if you are not receiving adequate relief from your symptoms. Your doctor may be able to reprogram the pump to adjust the amount of medication it delivers.

The Medtronic programmable, targeted drug delivery system allows full-body MRI scans under specific conditions. Your drug pump does not need to be emptied prior to MRI exposure. It is important to know that the magnetic field of the MRI scanner will temporarily stop your pump motor and stop drug infusion until the MRI exposure is complete. Your pump should then resume its normal operation. Your doctor will make sure your normal infusion has resumed after the MRI procedure.

Yes. The screening trial is designed to determine whether the pump will help manage your pain. However, your doctor can replace your medication with inactive sterile saline or surgically remove the system.

The SynchroMed® II drug pump is 8.6cm wide and 2.5cm thick.

Because your pump is placed near the surface of your skin for refill access, on occasion someone might notice a slight bump if you are wearing fitted clothes. However, depending on your size and shape, where the pump is implanted, and the size of your pump, it may not show under your clothes at all.

Some doctors choose to use an opioid medication in the drug pump. There are risks associated with the use of any opioid pain medication.

If you still have concerns you can either contact us, or arrange an appointment with your doctor. If you need help finding a pain management specialist, use our Find a Pain Centre tool to locate one near you

 

References

  1. Deer T, Chapple I, Classen A, et al. Intrathecal drug delivery for treatment of chronic low back pain: report from the National Outcomes Registry for Low Back Pain. Pain Med. 2004;5: 6-13.
  2. Roberts LJ, Finch PM, Goucke CR, Price LM. Outcome of intrathecal opioids in chronic non-cancer pain. Eur J Pain. 2001;5: 353-361.
  3. Doleys DM, Brown JL, Ness T. Multidimensional outcomes analysis of intrathecal, oral opioid and behavioral functional restoration Therapy for failed back surgery syndrome: a retrospective study with 4 years’ follow-up. Neuromodulation. 2006;9: 270-283.

Curious to hear what experts have to say about pain pumps? Below, you’ll find answers to common questions about targeted drug delivery, as answered by 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 Targeted Drug Delivery

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 the US, 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.

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. Grigsby says:
Targeted drug delivery therapy delivers pain medications directly to the spine. We place a very small tube in the spinal fluid sac, and attach it to a device under the skin that constantly drips pain relief medicine around the spinal cord. By placing the pain medication right at the site of action, you can use discreetly small doses to achieve a large effect on pain relief. Delivering the drug via the spinal cord has fewer side effects than the equally effective dose of opiate administered by mouth, with a patch or IV. That’s because the pain medication just stays in the spinal canal so you don’t get the constipation or short-term memory loss that may come with systemic medication.

Dr. Wellington says:
Targeted drug delivery therapy requires significantly lower doses of medication. 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 targeted 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, under specific conditions.

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:
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 a targeted drug delivery system we will have to work with you to find out what is the correct dose of drug that we should be delivering. So, during that time you need to be patient. And, you need to let us help you in finding the appropriate dose for you.