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Orthopedics Channel
Reported March 14, 2011

Easy Way To Relieve Back and Leg Pain -- In Depth Doctor's Interview

Richard Tallarico, MD, an orthopedic spine surgeon at Upstate Medical University in Syracuse, NY, tells us about an experimental procedure being used to relieve back and leg pain.

What kind of pain are we talking about today and how common is it?

Dr. Richard Tallarico:  For patients with spinal stenosis, the typical pain they have is called neurogenic claudication.  Neurogenic claudication, or intermittent claudication, is a symptom in which patients standing erect tend to have pain radiating in the low part of their back into their buttocks and often down their legs.  Intermittent lumbar radiculopathy is another form of symptom pathology that we see with patients with lumbar spinal stenosis and that will sometimes radiate into one leg or the other.  Patients tend to get relief when they flex forward into a seated position, or a stooped posture, and that’s because with that type of pain syndrome they are taking pressure off the nerves in the flex position and when they are standing erect they are dealing with pinching of the nerves in the low part of the back and that’s what creates their symptoms.

So it’s a spine problem, but that’s not where the pain is?

Dr. Richard Tallarico:  Often times, stenosis will radiate.  It can radiate into the lower part of the back, which is the portion of the spine that is involved.  So, when we are talking about lumbar spinal stenosis, we can get radiation into the back, buttocks and down the legs.  And the reason patients have pain radiating down the legs is because it is actually affecting the nerves that are traveling through the spinal column in the lower part of the back.

And how common is this?

Dr. Richard Tallarico:  Very common.  It’s the most common problem we treat in both males and females in the 50 to 70 age range.

Can younger people have it?

Dr. Richard Tallarico:  Absolutely.  We see it as early as 30’s and 40’s.  There are some people who have developmentally narrow spinal canals.  But primarily this is an acquired problem which happens with degeneration of the spine and the most common age group would be somewhere in 50’s to 70’s, but we do see it in 40 year olds as well.

And you can spot this on an MRI?

Dr. Richard Tallarico:  Imaging studies, x-rays, MRI images are the most useful.  We can sometimes see areas of degeneration in a lumbar spine on an x-ray and something called spondylolisthesis, with is a little bit of slippage in the lumbar spine.  But the most sensitive of tests for picking up lumbar spinal stenosis is with an MRI.

Some people get back pain and they say the doctors can’t figure out what it is, but this one sounds like a problem you can detect?

Dr. Richard Tallarico:  There are many sources of back pain, but this would be the most common complaint presenting to our office and it’s the one that we diagnose most commonly.  So, anyone who presents to our office with back pain complaints particularly if they have back pain radiating elsewhere in the buttocks or legs we have a high suspicion for lumbar spinal stenosis.  We’ll usually warrant other tests such as an MRI and for those patients that can’t have an MRI, because they have a pacemaker in place or something along that line, we can also make the diagnose with a CT myelogram.

What’s the usual treatment for this?

Dr. Richard Tallarico:  The usual treatment for lumbar spinal stenosis is conservative management. Combination of anti-inflammatory medication, physical therapy, and sometimes injection, spinal injection such as epidural steroid injections can be useful.

If none of those work, or stop working, for a patient what are their options before this trial?

Dr. Richard Tallarico:  So, standard treatment for lumbar spinal stenosis has been laminectomy, which is a decompressive procedure that takes pressure off the lower part of the back by removing part of the bone in the back of the spinal canal to convert the spinal canal from a bony constricting ring to more of an open space. And that has been the gold standard of treatment for patients with lumbar spinal stenosis.   Sometimes it requires a fusion, which is a more aggressive or invasive procedure and although these procedures have very high success rates they are often fraught with problems down the road where we have to consider redoing it because the stenosis can return, or fusing their spine because there is some form of instability with removing portions of the bony spinal column.

So, this is a major surgery?

Dr. Richard Tallarico:  This is a much more invasive surgery and, because of all the downfalls to decompressive laminectomy and decompressive laminectomy with fusion, we’re seeking out alternative options that would decrease the morbidity related to these types of procedures.

What is the length of recovery with the decompression?

Dr. Richard Tallarico:  It varies. It’s always based on individuals, but it is a more invasive procedure that requires us to split the muscles of the low back, which are the para-spinal muscles, which are instrumental in allowing us to stand erect. Most patients deal with discomfort in that region for six to twelve weeks after a more formal procedure. There’s more blood loss, higher rates of infection and because of that there tend to be longer hospital stays.  Because of the pain in their back related to the incision, patients tend to have a harder time getting up and mobilizing so they spend a little more time in the hospital and overall length of recovery is a little bit longer.

So, tell me about this new treatment that you are studying?

Dr. Richard Tallarico: In order to try and minimize the insult to the patient with surgery and minimize their time in the hospital and improve their recovery we are looking for alternative procedures to try to cut down on the risks and obtain overall results and also give them better longevity down the road where we don’t always have to go back in and do aggressive redo surgeries, which is very common in this patient population. There’s been a lot of interest in interspinous spacer technologies which are more minimally invasive type procedures where the neuro elements aren’t actually exposed and there is no bone removed from the back of the spinal canal.  What we do in effect is spread the spinal canal open by recreating a flex position in the spine by stretching the bony elements of the spine open and placing a wedge in that area.  This wedge is secured within that inter space and it allows the spine to remain in a flex position mimicking the sitting position, in which most patients get complete relief of their symptoms.   So, the appropriate candidate for this procedure is one in which they stay standing for any period of time or ambulating for any period of time creates radiating symptoms in their back or down their legs.  The patients that say when they sit they get complete relief of their symptoms those patients are appropriate candidates.  What we are doing, therefore, is target those patients that get relief by forward flexing.  We are locking the spine in a forward flex position to try and take the pressure off the nerve element. Currently, we are investigating a device from Vertiflex called Superion, which is the newer generation of these devices.  We’re able to place percutaneously, so we’re able to do this with less blood loss, smaller incisions and get the same effect of spreading the spine open and taking pressure off the nerve indirectly without exposing the nerve elements, without cutting away a lot of muscle or tissue, without fusing the spine.  So, it’s what we consider a motion preservation, a motion sparing device.

What makes this spacer different than the other spacers?

Dr. Richard Tallarico:  There are other spacers on the market. Currently this is the only one we are able to place percutaneously through a small skin incision directly from the back, so it’s easier on patients. It takes less time and this device has the ability to open up the spinal canal with very small surgical incisions.

How long is a typical procedure?

Dr. Richard Tallarico:  A typical procedure depends on how many levels we are treating.  In this study, we can treat symptomatic spinal stenosis from one or two levels.  Typically, it takes from 15 minutes to one half hour per spinal level.  Most surgeries are done within an hour and most patients go home the next day.

The recovery time is much shorter with this, right?

Dr. Richard Tallarico:  It is shorter than typical standard open procedures.  Depending how involved the procedure is, if it’s decompression alone vs. decompression and fusion.  Some of those procedures can be quite extensive and can have very lengthy recovery times even up to a year.  The interspinous spacer placement, particularly with the Vertiflex, allows us to get patients up and moving right away.  The bulk of the recovery has occurred within the first few weeks.

Does the patient feel relief right away?

Dr. Richard Tallarico:  Most patients with this type of problem will notice relief immediately, because remember we are mimicking the flexed spinal position and the patient is completely asymptomatic in that position, so what happens is that as soon as they stand erect they’re no longer pinching the nerves and they notice the first time they walk, or stand for a long period of time, that the pain that they usually endure after standing for a short while is no longer there. And what they’ll say is that they can stand longer or walk longer distances without having that symptom and that’s the disabling part of this problem.  Patients, after they walk a certain distance or stand for a long period of time, are immediately looking for somewhere to sit.  So, they have a hard time standing in line with bags, they have a hard time walking to sporting events or anything that requires them to be upright without having an opportunity to sit really creates trouble for them.  That’s how this problem becomes functionally disabling.

How disabling can it be?

Dr. Richard Tallarico:  In the most aggressive forms patients can’t stand or walk for more than a few minutes, so it’s very functionally disabling.  They can be very comfortable seated and you would not know that they had much of a problem when sitting down and eating a meal, or just having a chat with them, but as soon as they are up and walking you can notice that they are immediately looking for a place to sit.  It’s as simple as examining a patient in an exam room and asking them to walk the length of the room and they immediately want to sit right away. Those are the most symptomatic patients. There is a varying degree of symptoms.  With the more mild forms patients say they can’t walk more than a mile or whatnot.  Typically, for patients who want to be active and lead healthy lifestyles this problem progresses at a rate that really slows them down.  Usually, at that point they come for help.

This study is randomized, so you can’t tell the patient if he is getting the device. So how does the randomizing work?

Dr. Richard Tallarico: The typical process for someone who thinks they might be suffering from spinal stenosis and the symptoms of intermittent neurogenic claudication, or lumbar radiculopathy, would typically set up a consultation with a spine surgeon in their area and have their problem evaluated with an examination, history taking and then imaging studies.  Once a diagnosis has been made, we look to find whether or not the patient is appropriate for enrollment in the study.  Again, depending whether or not they have complete relief of the symptom when seated, whether or not they meet the FDA’s criteria for inclusion in the study, such as their age being appropriate, not a lot of other medical issues.   Once we determine their candidacy is appropriate we offer them enrollment in the study.  This is an FDA approved IDE study which is an Investigative Device Exemption Study.  Once they choose to enroll they have to understand this is a randomized process.  So, during the randomization process we are comparing the Superion device from Vertiflex vs. the X-Stop device.  What happens is they are one-to-one randomized so that we will have 50% of our patients enrolled in X-Stop and 50% in Superion and then the results over a long period of time will be compared to see if there is a quality, or superiority, of one device over the other.

How much longer will the study go?

Dr. Richard Tallarico:  We will be enrolling over the next six months to a year and then we will be following patients for many years.  Right now the study is set for two years.

So, if all goes well, how soon will this be available to the public?  Is this five years or 10 years into the future for the public?

Dr. Richard Tallarico:  Best guess…Maybe three years to market.

So, what effects are you seeing so far? This is not blind.  You know what they are getting and you know what patients have received it, so what are the results you are seeing?  What are you hearing from patients?

Dr. Richard Tallarico:  So far, I have been very pleased with the results.  Patients are getting out of the hospital sooner, getting back to their normal life and job sooner and they have been very pleased.  We are seeing the vast majority of patients having notable improvement right away after surgery and certainly after two week follow up when we see them back, many are asking to go back to work and getting back to driving and things on those lines.  So, I’ve been very pleased, particularly because I have lots of experience with the more aggressive surgeries and the more invasive procedures and although those patients, on the whole, do well also the recovery is much more difficult. So, it’s a longer process and it’s really great to be able to see patient get up and go right away.

It seems like an easy surgery to fix a very serious problem.

Dr. Richard Tallarico:  Yeah, compared to the options we had in the past this is a much easier way to approach this from both the patient and the surgeon’s perspective.

Are you hoping this is a permanent fix?  Is that the idea?

Dr. Richard Tallarico:  That’s difficult to say.  We don’t have enough information at this point to really see the track record over many years.  I think for some people there are some who will not require any further treatment.  There are others who will need other procedures down the road, but at this point we are optimistic that it would be a possible long-term solution for patients with spinal stenosis on one or two levels.

What is the age requirement?

Dr. Richard Tallarico: 45 years or older with no upper age limit.  The average age in the study right now is 68 years

END OF INTERVIEW

 This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.

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