Is a Common Medical Procedure Unnecessary?

(CBS)  Sister Rogene Fox, 81, was suffering from severe back pain until she agreed to a popular treatment, reports CBS News medical correspondent Dr. Jon LaPook. She believed it worked.

"I just thought, thank God. I don't care what I received," Fox said. "I feel good! I don't have pain!"

But it turns out she got relief without getting the procedure, called Vertebroplasty, a common treatment for patients with painful back fractures from osteoporosis.

Wednesday, two separate studies in the New England Journal of Medicine report there was no difference up to six months later for patients who actually had the procedure and those who had a fake or placebo treatment instead.

"I thought, 'Wow, we're onto something,'" said Dr. David Kallmes, a study author. "We saw many placebo patients get full pain relief. I have no idea why."

During Vertebroplasty, doctors inject medical cement into fractured bone in the back to strengthen the area and reduce pain. The placebo was just a shot to temporarily numb the area. Vertebroplasty is endorsed by multiple medical societies, but the surprising findings may force doctors to rethink the treatment.

"I was quite amazed," said Dr. Kenneth Chapman, a pain management specialist. "Vertebroplasty is one of the most rewarding procedures I do, and to take that and say that it doesn't work, to me, I have a hard time digesting that."

It's a money maker for specialists. In recent years, the number of these procedures has doubled to at least 40,000 annually, each one costing $2,000 to $5,000.

"Patients must be empowered to make decisions based on best evidence," said Dr. James Weinstein, the chair of orthopaedic surgery at Dartmouth-Hitchcock Medical Center in New Hampshire.

These results point to the kind of savings President Obama has said can be achieved, when there are well-designed studies on whether expensive treatments really work.

"I think that what we know is that right now there's a whole lot of care that's not improving health," Mr. Obama said in a July interview. "And our main focus is on how we can stop putting money into things that aren't making people healthy."

"These two studies I think represent great examples of the kind of work the President is looking for," Dr. Weinstein said.

But it remains to be seen whether physicians will change their behavior based on this new evidence.

"Everybody says they want evidence-based medicine," Dr. Kallmes said. "Sometimes the evidence is not what you asked for."

It's one thing for patients and doctors to believe a treatment works, it's another to know the facts. That's why Congress has earmarked $1 billion to study the effectiveness of many different treatments.

[Linda C. Wingate]

I had 5 kyphoplastys for 11 fractured vertabrae (spontaneous) I hane been suffering since the 4th out of 5 surgeries. I have what they call a dermatome. The pain goes from my back into my stomach. I have lost over 60 lbs in 3 months, needed it but this is not the way. My family misses who I was and hates who I have become. I have missed every Holiday. My husband is exhausted. I live in ER's and every test is normal. They call it a dermatome but noone knows how to fix it??? Is there anyone who can help me???? My 23 grandchildren want their grandmother to continue living their legacies with them...

[VanceTylerL]

The authors of the Mayo study did NOT conclude that vertebroplasty doesn't work. The media misinterpreted the results of medical research here once again. The reporting has been irresponsible since the reporters don't understand the intricacies in interpreting medical research. However, the media is quick to correlate these studies with recent statements by the Obama administration pertaining to eliminating ineffective treatments. Once again, irresponsible. Misleading.

[ysteb23]

Thank you for your comment. It very upsetting to watch/read the news and see that the Republicans are once again gaining ground scaring the s*?t out of a lot of Americans.

[jscavo412]

I truly hope that mainstream media eager to jump on the Obama policy bandwagon are not poisoning public opinion before checking the real facts. If this one story negates 20 years of clinical research than the most vulnerable among us (pain ridden elderly osteo suffers) are going to continue to suffer is silence.

Before I read these comments I found a link that says the study results have been misinterpreted and actually show vertebroplasty does reduce back pain. http://www.cnbc.com/id/32320616. For those of us not aided by the procedure as evident by the posts here, we should be checking facts before rushing to judgment.

[ILW]

I found my mother on the floor back in May. She had been on the floor for over 12 hours when I found her. She is 83 and has severe osteoporosis. She was not coherent enough to explain what happened. She was admitted and treated for heart attack/stroke. They kept her in the hospital for 5 days. They could not find anything wrong with her. She had every test known to woman (she got a very expensive physical out of this visit). She kept complaining that it hurt to breathe. The care givers thought she had 'tissue damage' from her 'fall'(she never fell she could not walk so she tried to crawl because of the fractures). They released her and within 48 hours she was readmitted and found she had compression fractures in T12 and L1. She was in so much pain and could not move or walk. The paramedics had to put her on a body board and transport her. She had a very good doctor who explained the procedure to me and that a MRI is the best test to identify all fractures. If you miss one you can still have severe pain. He did say she will never be 100% due to a bulging disc in her neck and her arthritis. He set realistic expectations and she is resuming normal activities. The doctor did say other fractures can occur above and below the repair. He also said the procedure was not a guarantee. I would have other fractures repaired. It is a quality of life issue. The moral of this story is our lives are much better for this procedure. The protocol should be anytime you have a patient with severe osteoporosis you should test for fractures. She was misdiagnosed. This would have saved on a readmit and 4 more acute care days plus 5 skilled nursing days. It has only been 3 months and so far so good.

[livinginsandiego]

I'd really like to know who these IDIOT RESEARCHERS are!!!!! Please, can you divulge this information because they will get plenty of hate e-mail. (Katie, when you report something as true, you need to tell us WHO says it's true.)

My 76 year old mother developed a compression fracture from osteoporosis and was SCREAMING in pain, couldn't move or walk, had this operation and recovered rapidly and is in no pain now and walks fine. Without this, her life and ours, would have been a living HELL! She would have been condemned to living in a hospital bed at home, doped up on pain pills, which still wouldn't kill all the pain!

I'm sure there are lots of unnecessary operations and other procedures that ARE a total waste of money that need to be done away with BUT THIS IS NOT ONE OF THEM!!!!!

It's a proven fact that the placebo thing works on some people - WHAT DOES THAT HAVE TO DO with this operation - come on now. Some people believe whatever they?re told! It doesn't mean vertebroplasty doesn't work.

It could also be the procedure was not done correctly?

It could also be that it works too darn well and whoever is making the $$$ wants you to stay in pain so you keep coming back and coming back, suffering and suffering and spending tons of money?

I am really outraged by this "so-called" reporting!!!!

San Diego, California

[cmansour]

I am the one who wrote the lenghty response previously about my mother and I just want you to know you are not alone in your anger. I don't think that they understand that we are talking about broken bones here that most people do not naturally heal from. If you broke your arm would it be acceptable for you to numb the pain and live with a broken arm just because it "felt" better? I am afraid that this is going to scare people away from getting the procedure. I also question if this anger is the response they are looking for so that people will think that if we had medical reform this is what we would have to deal with. Do not underestimate the tactics of people trying to stop reform. I am not usually so paranoid, but why would anyone release such a bogus report?

[bkb831]

So many people don't understand there are many different reasons for back pain. And a correct diagnosis of the problem needs to be found and assessed to determine the proper realm of care. If the diagnosis is correct and there definitely is a compression fracture, a vertebroplasty or kyphoplasty is probably the only treatment that will stop the pain. Allowing the fracture to heal on it's own over a few months is the only other choice of care. Anyone who is a caregiver knows there is a need for strong pain relief medication when trying to resolve pain caused by these fractures. This in itself is expensive and can be a problem for the elderly. As stated in another reply on the forum, I have been associated with more than 2,000 vp or kp procedures and more than 90% of these patients have gotten relief from this procedure. The relief was immediate on most. Within 10 minutes of the bone needles being pulled from the patient, they are moved to a cart, rolling from a prone position onto their back. This is when most patients will feel that their pain is gone. I'm not a physician, I am a specialist technologist in Interventional Radiology. These procedures are performed in my department by very qualified radiologists (physicians specializing in x-ray). There are many physicians performing the vertebroplasty procedure who are not as skillful as others. Some use very poor imaging to guide the needle to the correct site. All I know is that I have seen numerous elderly patients who are in terrible pain go through this procedure and the outcome is so great that I am a true believer in this procedure. As with all things, there are always a small number of people who won't benefit. This doesn't mean the procedure shouldn't be performed on others who will greatly benefit.

[TwoComments]

The radiologists in these study(s) are some of the leaders and pioneers in the field. What are you trying to suggest?

[bkb831]

I'm not suggesting anything, merely making a point that there are other physician specialties besides radiologists who are performing these vertebroplasty exams. Pain management Drs. are allowed to perform this study in some medical centers. Surgeons also perform them. There are different techniques used by all. And if I am trying to suggest anything at all, I guess it would be that this study is flawed. Many things could have been done to make it a more controlled study. If these researchers would be able to see the relief patients get with this procedure, that would be enough for them. And if your mother had a compression fx, would you want her to suffer for a few months and take all sorts of pain meds just to let the fx "heal on it's own". I bet you would opt for the procedure that "works".

[bkb831]

In response to this news report, I think people need to see the overall story and most lay-persons will still not understand what this vertebroplasty procedure or the placebo treatment actually consists of. I am a vascular specialist technologist in an Interventional Radiology department and have assisted with more than 2,000 vertebroplasty / kyphoplasty procedures. I can honestly say that more than 90% of our patients who have had this procedure had pain relief almost immediately after the bone cement was injected. There are a small percentage of patients who don't get much relief at all for some unknown reason. With me being a technologist, I am always skeptical of new procedures and usually chalk-up most of them as a fad or "voodoo medicine". It only took a few months to realize how effective this treatment was for compression fractures in elderly patients. I can't imagine how the results of the placebo treatments could be long lasting and comparable to the vp procedure. As stated in other comments from experts (Drs.) , technique and skill is involved in this procedure. If not performed in a manner to get the best results, the patient may not benefit. There will always be arguments over what treatments are best for patients. But now, we at least have the choice to make that decision rather than having some bureaucracy dictating what procedures can and can not be performed.

[cmansour]

Something is so wrong with this study and I am greatly concerned that it is mis-leading people and will prevent some of them that are suffering from compression fractures from getting this procedure done.

My mother, 92 year old, had Kyphoplasty 7 years ago to repair 3 disks that had compression fractures.
My mother has Alzheimer disease and did not have a doctor "convincing" her that this procedure would make her pain go away. I find it impossible to believe that as Power of Attorney, my being convinced that this procedure would work would have had any effect on my mother. My mother has been incapable of reasoning for decades. She screams when she is in pain and doesn't when she is not in pain. It is a pretty simple existence.

The change was dramatic and instantaneous after this procedure and this after having to be tethered in bed and howling with pain even while she was on high doses of morphine for over a year. Her surgeon was very careful to manage my expectations and clarified that this would not cure her Alzheimer's, her failing kidneys, her blindness, her arthritis, her osteoporosis, the curvature of her spine or all of the other damage that was as a result of being crushed by a tractor in 1955. What it could and did do was stop her vertebrae from breaking further. It is a physical injury and to suggest that a placebo can repair a broken bone is crazy and I know crazy.

In the case of my mother she was not able to get completely off morphine because of all her other issues. But because of this procedure we are able to manage her pain and that is such a blessing. If there is any way that you can give someone with Alzheimer's the slightest improvement in their quality of life, you grab it. There is a myth that all pain can be managed but that is not true and the pain from severe compression fractures is one of those pains.

This study is so misleading, it doesn't say that the procedure didn't heal the compression fractures, it just says that they weren't feeling that much better. There could be reasons that they aren't feeling better that have nothing to do with compression fractures that were repaired. Like I said, my mother is still on a morphine to manage her pain, but it is pain not related to compression fractures

Funny thing is that when I researched and found this procedure back in 2002, I asked why it wasn't being done all over and why didn't more doctors know about it. The answer I got was that there was a lot of money being made on the pain medication and by the facilities treating people with compression fractures and that they were stifling its acceptance even though the cost was approved by Medicare. The cost of this procedure is a tiny fraction of the cost to have someone in a health care facility on high doses of morphine. This report is misleading and will cause much higher medical costs and rob people of the chance to have a better quality of life.

[TwoComments]

The NEJM articles said nothing about how well kyphoplasty does or doesn't work. Don't mislead yourself.

[cmansour]

The article misleads by not making it clear how well the procedure does or doesn't work. Don't you think they should have included that critical fact?

[PTNoonan]

Having performed more than 1000 of these procedures myself, I have personally seen numerous patients with compression fractures due to osteoporosis as well as cancer who were either bedridden or otherwise so limited by their pain that they became dependent on others to perform their activities of daily living. In vrtually every case, vertebroplasty immediately reduced their pain and brought them to a level of function that conservative therapy would have taken at least three months and at least several refils of narcotics to achieve. It is one thing to tell a patient whom you don't know that they cannot have vertebroplasty on the basis of studies that may be biased in case selection and it is another thing entirely to be either the patient or a caregiver who's life is limited by pain. I wonder whether or no the authors of these studies would proudly refuse vertebroplasty for themselves or their mothers' in such a situation. If so, then let them find comfort in their own medicine. I am certain that their mothers' would have a different opinion.

As an aside, when I saw the presentation of the first data from a precursor to these studies at a medical meeting a few years ago, I was surprised that the patients receiving the vertebroplasty procedure rather than the sham procedure had minimalist injections of the bone cement compared to what I and others with good results typically inject. On reading the study published in the New England Journal of Medicine on 06 august 2009, it is readily apparent that without any images of the treated vertebrae that I cannot conclude that the cement injections performed by this group of physicians on 68 of 131 selected patients at a number of medical centers is anything other than minimalist. Secondly, a higher proportion (63% vs. 51%) of the patients who received the sham procedure correctly guessed the type of procedure by 14 days and 43% of the patients who had received the sham procedure "crossed over" in order to get the real procedure but only 12% crossed over in the opposite direction. If the real procedure and the sham were equivalent, then such a lack of confidence in the sham procedure on the part of the patients who suffered the pain of the procedure - whether or no it is a sham, the procedures caused pain and discomfort - would not have been evident. These patints must have been thinking "Why should I suffer undergoing another sham procedure when I know from my experience that relief of my compression fracture pain will not be satisfactory?" Thirdly, careful reading of the study reveals that an initial goal was to enroll 250 patients with sufficiently painful compression fractures, but because of problems with enrollment (e.g., 368 patients with suspected tumors and 704 patients either refused to participate or were excluded for "other" reasons ), only 131 patients were actually enrolled thereby lessening the power of this study. There is of course no word as to how this group of 1072 patients was treated. In a busy practice in any major hospital, commonly more than 131 patients with painful compression fractures due not only to osteoporosis, to which this study is limited, but also due to tumors and even trauma that are not even addressed by this study, will be treated by a typical operating physician in a year. The experience of such an operator, the referring primary care physicians, the patients, and the caregiving family members is quite different from that indicated by this study. Unfortunately, I fear that this common experience will be ignored by entities such as the newly created Coordinating Council on Effectiveness Research of the Department of Health and Human Services should it receive a mandate to determmine whether or no any currently reimbursed medical or surgical treatment be allowed. The elderly who are the majority suffering form this disease are about to enter a painful new era on a road paved by studies such as this.

Patrick Noonan, M.D.

[TwoComments]

Good for you for reading the article. There is a second article/study in this NEJM issue as well and the results were largely the same without any crossing over. Strength in numbers...

The studies don't suggest that patients undergoing vertebroplasty don't get better. They suggest that they do get better, just not any better than if you give a patient a local anesthetic (safer and cheaper).

[bayrat42]

I was involved in an accident Sept. of 08 causing commpresion fractures to my T-12 vertabrae, since then my life has been a living hell. I had Kyphoplasty performed in Feb.09 for the first three months it was great. On a scale of 1/10 my pain went from a constant 8 to 0 however it has gradually returned to a constant 6-7 with elavations to 8-9 whenever I exert myself even a little.This has left me unable to work forcing my wife to try and support a family af six on $852 a month. When I tell my doctor I'm still in pain He tells me I'm not like I'm some kind of idiot who does'nt know when he's in pain. While this procedure may be a permanent solution for some it was not for me. It has only caused me more despair. Leaving me with the very real possibility of social security death benefits as the only way to provide for the family I love.If anyone has a better solutin I'd love to hear it.

[amabeliever]

Please find a different doctor. You did say that the first three months were great. So what happened? Something changed. Have you had new scans? Is another problem, like disc injury or degeneration causing the pain? If your scans are normal, please see a pain management specialist. They can recommend things that can help.

[ILW]

You may have another compression fracture. The doctor explained to me that a MRI will detect the fractures. My mother had a CAT scan and it identified L1 fracture. The MRI identified the T12 and L1 fracture. She is doing great and I do not put much stock in the study. The doctor said to pay attention to the vertebrae above and below the repair because they can fracture next.