An estimated 400,000 Americans over the age of 60 struggle with back pain caused by lumbar spinal stenosis, a narrowing of the spinal canal. For many patients, surgery is not the only option, and a new study shows other treatments may be just as effective for long-term relief of chronic pain.
Seventy-five-year old Stephanie Paul is committed to staying active. But until recently, pain in her back, on a scale of 1 to 10, was nearly unbearable.
Paul said, "There were many times when it was an eight. It was just on the lower back. It was just an ache."
Stephanie had lumbar spinal stenosis. As she got older, her spinal canal narrowed and put pressure on nerve roots causing cramping in their legs.
Anthony Delitto, PT, PhD, Chair of Physical Therapy at the University of Pittsburgh and UPMC told Ivanhoe, "Generally, a city block or less will bring it on, and then they sit and the pain goes right away."
Physical therapy or surgery can relieve the pressure. In a first-of-its kind trial, University of Pittsburgh researchers studied which approach is best.
One-hundred-sixty-nine patients considering surgery agreed to be randomly assigned into groups. Half had surgery, the other half had physical therapy, two sessions a week for six weeks. Therapy included cardio and bending exercises.
"Almost half of the people were able to avoid surgery at the end point," Dr. Delitto explained.
For Stephanie Paul, physical therapy has made a huge difference.
"I said to my husband, when I leave here I feel like I can take on the world" she said. Starting with the walking trails near her hometown.
Researchers say the results suggest doctors and patients should exhaust all non-surgical options before moving to surgery. Also, researchers found one of the biggest deterrents to physical therapy was cost. For most patients, especially those on Medicare, co-pays of $25 or $30 per visit added up.
Contributors to this news report include: Cyndy McGrath, Supervising/Field Producer; Cortni Spearman, Assistant Producer; Jamison Koczan, Editor and Kirk Manson, Videographer.
BACKGROUND: Currently there are as many as 1.2 million Americans with back and leg pain related to any type of spinal stenosis. It is estimated that 400,000 Americans over the age of 60 are suffering from lumbar spinal stenosis. The lumbar spine is located in the lower part of the spine between the ribs and the pelvis and consists of five vertebrae. Lumbar spinal stenosis is a condition where the spinal canal begins to narrow which results in compressed nerves through the lower back into the legs. Lumbar spinal stenosis has been seen in younger patients due to developmental causes but it is more often a degenerative condition that affects patients 60 years and older.
SYMPTOMS: Depending on how severe the condition is, lumbar spinal stenosis may or may not produce symptoms. Symptoms can include:
· Pain, weakness or numbness in the legs, calves or buttocks
· Pain radiating into one or both thighs and legs
· Loss of motor functioning of the legs
· Loss of normal bowel or bladder function
In many cases the pain may decrease or subside completely if you bend forward, sit or lie down. Walking short distances may cause the pain to get worse.
NEW TECHNOLOGY: There are many treatment options to help relieve the pain and pressure of lumbar spinal stenosis including surgical and nonsurgical treatments. Nonsurgical treatments include anti-inflammatory medications, epidural injections and physical therapy. University of Pittsburgh researchers are studying if surgery or physical therapy is better for those suffering from lumbar spinal stenosis. In a study of 169 patients the outcomes were equal, but Anthony Delitto, PhD, chair of the Department of Physical Therapy at the University of Pittsburgh said, "People don't exhaust all of their non-surgical options before they consent to surgery." Researchers say patients should save surgery as a last resort.
Can you give us some background on spinal stenosis?
Dr. Delitto: In its simplest form, spinal stenosis is a narrowing of the spinal canal. On the lumbar spine, we have a canal which is where the nerves exit the body and become smaller. The cause of it is usually degenerative changes of the spine. When it becomes symptomatic, then we link stenosis with the problems that people have. When you see somebody that says they have a diagnosis of lumbar stenosis, what they have is the combination of the narrowing and the symptoms. The narrowing itself doesn't really constitute much because as we get older, all of our spines have some level of stenosis.
You mentioned the normal part of aging is the narrowing of the spine, but not everyone who has that narrow spine will feel the symptoms. Is this correct?
Dr. Delitto: That's correct. The hallmark symptom of lumbar spinal stenosis is pain when a person walks a certain distance. That pain is a cramping feeling that they actually feel more often than not in their legs. It gets to a point where we call it, claudicating pain. Generally, it's so severe they have to sit, and then the pain goes away. As people get older, the stenosis is a degenerative process that usually gets worse. And, it's critical as people get older to remain active. So, if you take away walking or walking is so painful, then you're taking away one of the major mechanisms for people to stay active.
What are the options if somebody has spinal stenosis and it's beginning to impact the quality of life?
Dr. Delitto: The most important thing is to make sure the findings corroborate the lumbar stenosis. People can have leg pain when they walk for a variety of different reasons. They can have hip osteoarthritis or other kinds of lower extremity problems. You can have a lot of people walking around without symptoms who have lumbar stenosis. Then, the options are to either look at things surgically or non-surgically. That is what led us to this study. People have tried injections and physical therapy that involves a lot of flexion-related activities. We also include aerobic activities and encourage patients to stay active.
Is surgery a last ditch effort or do you find a lot of patients tend to go that way?
Dr. Delitto: It depends on how much patience they have and how much they've been exposed to the non-surgical options. Surgery can be very effective when a surgeon goes in and decompresses that area and relieves the pressure on the nerves. Patients will have this almost immediate beneficial effect from the surgery. If they're decompressing an area that wasn't causing the leg symptoms, then that patient is not going to have a very good finding.
What's the benefit to the patient of not going through the surgical procedure and trying something else first?
Dr. Delitto: The benefit by far is decreased risk because surgical intervention comes with a risk. In general, you have about a fifteen percent chance of a complication and about half of those complications are severe.
It's not that the surgery itself is so risky; it's just that you're doing surgery on older people and many times these people come in with other co-morbidities that just make surgery a risk.
Talk about the study.
Dr. Delitto: I work with a team of surgeons and physical therapists and we had known for a while that some people do well with surgery and some people don't do well with surgery, and some people do well with physical therapy and some don't do well with physical therapy. So, we decided to put the two interventions head to head. We were aware of studies that were done previously in this and tried to do the study a little bit different. It was really a head to head comparison of surgery versus physical therapy for lumbar stenosis.
What were your findings?
Dr. Delitto: First, we assigned someone to surgery and then assigned someone to a non-surgical group. However, people who were assigned to surgery, may not have wanted surgery and then people assigned to non-surgical arms, may not want that option. That defeats the purpose of randomization, which is the hallmark of a study. So, we wanted to do something that would reduce the amount of crossover in at least one of the arms of the trial. This is how our study was formed. We made our patients first consent to surgery and then consent to the study. When they were randomized to surgery, they were much less likely to crossover. The other thing we did in the non-surgical arm was mandate a physical therapy intervention. The previous studies for the most part gave patients a lot of options and sometimes the patients went to physical therapy, but usually it was less than a quarter of the time.
Were there any specific procedures within the physical therapy?
Dr. Delitto: It was a very active form of therapy. There are a lot of flexion-oriented exercises that we put people on. We encouraged activity, we showed people how to use posture, how to use flex postures to try to modulate symptoms and improve their walking capacity. We put everybody on an aerobic program of exercise and introduced people to the stationary bicycle. Most patients with lumbar stenosis can tolerate a stationary bicycle pretty well because they're in a flex posture already. We also used other means of aerobic routines. We examined the patient a lot more closely to look for those other causes of leg pain. For example, hip dysfunction and other sorts of muscular skeletal disorders that we could address.
What were the findings with the physical therapy?
Dr. Delitto: No matter how we looked at it, the groups were about the same. The first finding that probably was surprising to everybody was when we looked at the intention to treat analysis, which was looking at the patients as they were randomly assigned, there was no difference in the groups. But, both groups improved substantively in a clinical meaningful way. However, two years out when we looked at the primary end point, the groups were the same. Now, that's not the whole story. The people who were assigned to the surgical arm of the trial for the most part had surgery. The people assigned to the physical therapy arm, a little over half of those people crossed over to surgery, but over the two year period. The other way of looking at that is a little less than half of the people avoided surgery at the two year mark. We were basically able to avoid surgery at the end point for almost half of the patients. No matter how we analyzed the data, even with some pretty sophisticated statistical methods that took in to account crossover, the groups were the same.
Is that surprising?
Dr. Delitto: I think it was surprising to some. What our interpretation is of this study is that we think people don't exhaust their non-surgical options when they consent to surgery. We probably had some people in the non-surgical arm of the trial that had never really given the non-surgical option a real shot and when they did, they actually improved.
What's the implication from your study?
Dr. Delitto: We should strongly encourage people to exhaust the non-surgical options before they consent to surgery. A supervised, regimented exercise program with a strong educational component that includes how to use posture to modulate symptoms is most beneficial and should be given the chance. Those are all really very important things to do and all patients should try that before they consent to surgery. If that's not effective, then surgery certainly is another option. However, they should understand the risks of surgery and the benefit, which is usually an immediate improvement, but that improvement sort of gets less and less over time.
What are some of the reasons why people don't exhaust the physical therapy option? Is physical therapy covered by insurance?
Dr. Delitto: It's covered, but not covered the way surgery is covered. Usually, physical therapy is a benefit under Medicare and has a cap, so patients who are on fee for service Medicare, can only spend a certain amount of money. It's a little less than two thousand dollars per year on physical therapy. That's more than enough to cover a physical therapy regiment for lumbar stenosis, but people have a lot of co-morbidities and they could be needing physical therapy for a lot of other things. The biggest barrier though is the patient co-payment that goes along with a lot of the Medicare products. The co-payment amounts to anywhere from twenty five to thirty five dollars per visit to the therapist. That really adds up and patients told us that was the reason some of them didn't go to therapy even though they were assigned to therapy.
How big of a problem is lumbar stenosis in the U.S.?
Dr. Delitto: Lumbar stenosis is one of the fastest growing problems out there. The incidence is getting greater and greater. We didn't study fusion, but fusion rates are going way up. One of the exclusion criteria for our study is we didn't look at patients who needed fusion, but that's another study that probably needs to be done. It's one of the leading reasons why people have muscular skeletal problems as they get older.
Is there anything else you would like to add?
Dr. Delitto: The other finding in our study that I thought was intriguing was when we looked at everybody who had surgery, women didn't do as well as the men did. That is a finding that we're continuing to look at right now with some of our secondary analysis. None of our baseline data picked it up. They didn't improve to the same degree as men and then men continued to improve across the two year time frame and women sort of stayed at a level pace. They came in a little worse than men, but we were able to control for that baseline difference statistically. This does speak to a number of issues that we'd like to look at. For example, is pain from lumbar stenosis complained about differently with women and men, similar to heart disease? We recently discovered that women don't come in with the same sorts of complaints from heart disease as men do. I talked to my female friends as well as my wife and they're quick to tell me that women just don't complain as much as men. Women wait until things are worthy of complaint before they go and see someone. Then, of course, perhaps there are other anatomical factors we should look at. The pelvis and the lumbar spine are the part of the body where there are differences in men and women. We don't think they had more disease than men did because everybody met the same criteria for surgery.