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Anne Asher

Does Vertebroplasty Relieve Back Pain?

By August 6, 2009

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Vertebral fractures are breaks in one or more spinal bones. Often caused by osteoporosis, they are most prevalent in elderly people and can create a lot of back pain. There are two types of surgeries that can be given to address spinal fractures: Vertebroplasty and kyphoplasty. The surgeries are related in that cement is injected to stabilize the bone and reduce pain. Also, both are minimally invasive procedures.

Two new studies found that vertebroplasty is not really effective for relieving back pain due to osteoporotic spinal fractures. The studies, similar to one another and published in the August 6, 2009 issue of the New England Journal of Medicine are the first randomized controlled trials to be done on the effectiveness of vertebroplasty.

One study looked at 71 people and the other, 131 people. Half the participants were given a vertebroplasty (an injection of bone cement into the fractured area), and the other half were given a shot of a temporary pain reliever, a fake vertebroplasty, if you will. Participants then filled out questionnaires designed to assess their level of pain, as well as their ability to carry on with their usual activities. In both studies, the pain relief obtained was about the same for all patients. In other words, it didn't seem to matter whether the patient had the real vertebroplasty or the harmless injection - the outcome was about the same.

With the health care debate raging, this discovery provides an excellent example of how money can be wasted with needless medical procedures. This is, of course, provided that the study findings are valid. Although the studies were well designed (both were randomized, blinded trials), they were small.  It's possible the results may not truly represent how well vertebroplasty reduces back pain in the entire population of people with painful osteoporotic spinal fractures. In an editorial in the current issue of The New England Journal of Medicine, Dr. James N. Weinstein estimates there are approximately 1.4 million persons worldwide who suffer from spinal fractures, with about 750,000 in the US. He also says that approximately 1/3 receive vertebroplasty. So 200 study participants seem like a drop in the bucket when compared to the number of vertebroplasties that are given. Just the same, I agree with President Obama - why spend money on medical procedures that are not doing the job of, in this case, relieving back pain?

Like many types of back surgeries, the use of vertebroplasties are on the rise. Weinstein says the number of procedures given have doubled in the last 6 years. He also estimates that in 2002, the cost of treating osteoporotic spinal fractures was, collectively, between 12 and 18 billion dollars. The two studies published this week in the New England Journal of Medicine are comparative effectivness studies, the type now called for by the President. Comparative effectiveness studies are those that evaluate the outcome of the various treatment options for a given condition.

Relief for back pain is elusive at best. For the most part, there is little correlation between the diagnostic and treatment options given by doctors and substantial pain relief for patients. Only recently has the medical profession chosen to address the hodgepodge of possibilities for relieving back pain by organizing research backed guidelines doctors can follow. Keep in mind, though, that not all back pain treatments have been fully studied at this time.

| Vertebroplasty | Kyphoplasty | Back Surgery |

Sources:
James N. Weinstein, D.O., M.S. Balancing Science and Informed Choice in Decisions about Vertebroplasty. New England Journal of Medicine. August 6, 2009.

Rachelle Buchbinder, Ph.D., et al. A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures. < i>New England Journal of Medicine. August 6, 2009.

David F. Kallmes, M.D., et al. A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures. < i>New England Journal of Medicine. August 6, 2009.

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Comments
August 7, 2009 at 1:24 pm
(1) jscavo412 says:

Everyone questioning this should look at http://www.cnbc.com/id/32320616. It says study results have been misinterpreted and actually show vertebroplasty does reduce back pain.

I checked out YouTube and searched Vertebroplasty and found some good videos too.

I wonder how you can decide how effective this procedure is with so few people tested.

August 7, 2009 at 1:44 pm
(2) Anne says:

Hi, jscavo412,

First of all, this is just 2 studies. They are significant because they are the first randomized, controlled clinical trials on the subject of vertebroplasty. Randomized trials provide the most reliable data of any study type.

Also, my impression is that researchers were surprised by the fact that pretty much EVERYONE who got the harmless injection felt better. This does not mean a conclusion is being arrived at; rather, it raises questions like could the numbing substance used for those not having vertebroplasty possibly be useful in relieving pain associated with spinal fracture? My opinion on this is – possibly, but I would want to make sure that the bone itself is stabilized, as well, so that there are not future injuries related to the spinal fracture. In other words, while it’s important to relieve pain, let’s not forget to prevent a worsening or recurrence of the injury down the line, as that could be even more painful when it happens.

Anne

August 7, 2009 at 2:22 pm
(3) jscavo412 says:

I think your assumptions are somewhat correct Anne. The fact that the news called his a harmful injection rather than what it really is (a facet injection) which is a legit procedure is what’s got docs I know up in arms. I found this on another post “Page 571 of study says “that a solution of lidocaine and bipuvicaine was used”"

The bottom line is that more data and more research are needed. Both studies had trouble recruiting patients, so the resulting groups were very small.

August 7, 2009 at 2:55 pm
(4) Anne says:

jscavo412,

Yes, the “harmless injection” was meant as a placebo, so that participants and others involved had no idea if they were getting the real thing or not. This keeps the data from the study honest. The study abstract as published in the New England Journal of Medicine said that a numbing agent was used, which, as I said, then poses the question, could pain relief for spinal fractures be had with an injection of an anesthetic? Just as you said, more research is needed.

I never heard anyone from the news media call the injection harmful, but this brings up the problem with getting your health information from a broadcast TV program or similar outlet. Anchors are trained in on camera delivery of items that come off news wires, and generally have little to no understanding of the health info they report. That’s why it’s best to come to the Back and Neck Pain site here on About.com. I specialize in the information first; “Getting the story” out to the public before anyone else is NOT my motivation. Accurate, useful info is.

Thanks,
Anne

August 8, 2009 at 6:37 am
(5) Michael L. Whitworth, MD says:

Professor Nik Bogduk from Newcastle Australia demonstrated in a small study in 2008 that injections into the medial branches of the primary posterior rami (the place where the vertebroplasty “placebo” was injected) gives good pain relief following vertebral compression fractures. This is NOT a sham or a placebo as claimed by the vertebroplasty researchers given the data presented by Dr Bogduk. The mechanism of relief from vertebroplasty is debatable but would seem that capsular distension of the facet joints due to wedge compression fractures is at least part of the pain producing issue. Placement of large 11 to 13 gauge needles directly through the nerve (as is done with vertebroplasty) causes severing of the nerve and thus reduction in pain transmitted from the facet joints. Therefore, the conclusions reached by vertebroplasty researchers are incorrect based on use of a therapeutic injection, not a placebo.

September 8, 2009 at 3:41 pm
(6) John says:

Dr. Whitworth, do you happen to have the reference for that Bogduk study in 2008? I cannot seem to locate the details for that particular study online. Thank you.

September 10, 2009 at 8:51 am
(7) Mallory Simons says:

Well-noted pain physicians question validity of study, not procedure:

-”The conclusion that vertebroplasty does not help back pain is completely wrong. If you look closely at the design, what they are calling a placebo is actually a facet injection.” -Allen Burton, MD: Professor of Anesthesiology at MD Anderson in Houston

-”The trends in the data demonstrate that if the study had enough patients, the group receiving vertebroplasty would have had significantly better pain reduction than the other treatment groups.” -Paul Lynch, Assistant Professor at Mayo Clinic College of Medicine and co-founder of Arizona Pain Specialists

- “…4 times as many patients-or 43 %-who had the control treatment crossed over to have vertebroplasty performed, compared to 12 % of vertebroplasty patients who switched. A 12 % dissatisfaction with vertebroplasty is in line with the many studies that have shown clinical success rates of 80 to 90 % pain relief following vertebroplasty…”

“…the trends in the data show that if the study had enough patients, the group receiving vertebroplasty could have demonstrated a clinically meaningful improvement in pain. It is therefore surprising that a study that is showing a trend toward statistical significance was terminated early with only half the number of patients recruited. A huge doubt now remains as to whether a study with the original intended group size would have yielded a different outcome.” -Mubin I. Syed, FACR, FSIR, co-founder of Dayton Interventional Radiology

November 14, 2009 at 8:07 pm
(8) Gary Glaze DO says:

Dr. Weinstein reports the rapid increase in the number of vertebroplasties performed and their gographical concentration concentration as a reason for alarm and further study. I would submit that during tha early days of Epidural analgesia for Labor and Delivery, similar “alarming trends” would be noticed. What is truly alarming is that we allow the elderly to remain in pain when something could be done. Like Epidural analgesia for labor, there was a learning curve with physicians which explains the geographical maldistribution. Also, there are 750,000 new cases of vertebral body fractures each year and the fact that only 1/3 of these patients are given tha benefit of vertebroplasty or kyphoplasty indicates to me that theer is a significant number of patients that go with out help and suffer needlessly.
Vertebroplasty and kyphoplasty are PROVEN treatments for painful vertebral body compression fractures. To give weight to poorly designed and executed studies and remove an effective treatment for millions of people, allowing them to needlessly srffer, is not only wrong but immoral.
I have taken care of patients and family members before and after the advent of vertebroplasty and kyphoplasty. There is no doubt in my mind of the effectiveness and “standard of care” that vertebroplasty and kyphoplasty bring to these patients.
In reveiew of the Kallmes study I would ask people to think about why there was a need to use 11 medical centers in 3 different countries to study a disease that effects 750,000 people annually in the USA, just to get 131 patients? Did they leave the most needy out of the studies? Why did they think that changing the selection criteria after the first 3 paitints was not going to induce selection bias? Can one really believe that the remaining patients in any manner represent the typical patients we see in our practice? Why did they not use a standard of diagnosis prior to the procedure? (MRI or NM Bone Scans were not required for all patients). Why did they never mention weateher the “back pain ” was directly associated with the fracture site? Why were other causes of back pain not considered? How does a “skilled practitioner” give a patient a spinal headache under a fluoroscopic guided peocedure that doesn’t enter the spinal canal? Why did they allow the patients to cross over after 1 month, but not provide the alternative treatment until after 3 months? 88% of the vertebroplasty patients were happy with there level of pain relief at 1 month vs. 57% of control. A strange oddity of patients statistics revealed that 7 paitnets in “sham” group and 2 patients in the vertebroplasty group thought they had had the vertebroplasty and still chose to cross over to the sham group! What kind of person does this?
It boggles my mind that a study this flawed could end up in the NEJM. I guess controversy sells and the bottom line is the bottom line.

September 21, 2011 at 1:15 am
(9) Vicki says:

In 2007 I had a bad fall which I literly slamed down on my upper back. i knew something was terribly wrong when I bare- ly moved. I lay there for five minutes to catch my breath,then slowly inched my way to the foot of my bed to help to pull my-self up. The second day I called my nurse practioner, told her symptoms. I got lucky & did not have to drive seventy five mil-es to Dr.It was his Friday to come to a city closer, only forty miles. He told me I had a T-12 fracture & basically I could wear a brace for about six months or there was a procedure..I decided to speak to the person who would fit brace. After talk-ing with him, seeing the brace, learning I would’t be able to move around, take care of my disabled husband with a plethra of medical problems, keep house, outside work etc. for about six months.I called the office & said schedule me as soon as possible. I never looked back. Best decision I made that year. Yes I was sixty eight years old who had a triple fusion in my forty’s, with nerve damage to right foot, that assisted in my fall. But I had a work load of someone much younger. But aside from that, I am not the kind of person to go down easily. Now it has happened again, four years later. (After fifteen years of illness, my spouse died two years ago.) This time I slammed down on lower back. I have waited two weeks, could not stand pain when doing anything, so called,had MRI & am driving seventy five miles with film in hand, (report faxed to nurosurgen)Shows a fracture of my tailbone. Pray he can do the same thing again.I had to have help with my sacks of groc-ies,laundry soap etc. to car from Wallmart Super,a first. I took food in,& left the rest. ,I am very uncomfortable.Pain pill will be taken.thats against my daytime rules.Again,I pray he can help me. Yes,its a miracle as far as I am concerned. Do I have way to many places my back will not move with fusions and cement, yes,but in case I happen to live another ten years,I’ll take the cement.

May 8, 2012 at 1:32 am
(10) Cindhy20 says:

This blog post is excellent probably because of how well the subject was developped. I like some of the comments too though I would prefer we all stay on the suject in order add value to the subject!

Dr. Carl Balog

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