randomized controlled studies that show back surgery works

Issues involving ear crops, declaws and knee and back surgery. Questions, answers, theories, and evidence. Why are these surgeries more common in the United States than Europe?

randomized controlled studies that show back surgery works

Postby malernee » Tue Feb 10, 2004 6:45 am

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Back surgery Decompression

Postby skyranger » Wed Feb 25, 2004 10:01 am

Art et al; Long ago and far away I attended training in Disc Surgery. Installed Air at my Hospital for air drills etc. In the finaly analysis I concluded that the physiotherapy and nursing care was as effective as the surgery on Herinated discs.

There are always good examples at the extremes of a question. Yes, I had failures as well as successes. If I had the problem in my own body, I would think very long and very hard about having the surgery.

Maybe the graceful way out is to say that every case is different.

Oh Oh... I feel a story coming on.... This may make some folk believe in Chiropractic manipulation. A Doxie paraplegic was diagnosed as Disc Disease, Physiotherapy was begun while we radiographed and consulted on a decision to operate or not.

It was our plan at that time to put Doxie in a Bathtub and run a stream of warm water on his back while the tub filled to a level where his toes would just touch the bottom and he could paddle about with little stress on limbs and back. The Vet Tech [this was so long ago the term Vet Tech was unknown. I hired RN's] for some reason the nurse stepped away from the tub leaving the water running. I entered the treatment room just in time to see the tub was FULL and running over. AND just in time to see the Doxie FLOP OVER THE SIDE. Hitting flat on his back on the quite solid Terrazzo floor. A terrible SPLAT! I was horrified, knowing that surely some terrible damage had occurred to the patient. In a second my mind ran thru all the possible courses of action and what to do first. After that second, the little guy turned over, stood on all fours, waddled over to the wall and lifted his leg on the corner!

He went home that afternoon walking well. Yes I quietly took ALL the credit! One has to salvage what success he can from a profession that keeps us humble.

Regards,

Mac
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polyethylene glycol, or PEG for bad back spinal cord repair

Postby malernee » Fri Dec 03, 2004 7:04 pm

Scientists Reverse Paralysis in Dogs




Dec 3, 6:28 PM (ET)

By RICK CALLAHAN








INDIANAPOLIS (AP) - Dogs with paralyzed hind legs regained the ability to walk after getting a shot of a chemical cousin of antifreeze that helped repair nerve cells in their damaged spinal cords, scientists reported.

Purdue University researchers who led the project hope the approach can soon be tried in people, but caution that there are significant differences between human and canine spinal cords.

The treatment only worked on dogs given the injections within about three days of their injury. Some dogs not given the injections eventually walked again, but those getting the new treatment had a dramatically higher recovery rate.

In one case, a dachshund named Oscar was initially sent home with a wheel cart and little hope of recovery after a serious injury.

Soon after the dog got the chemical treatment, he began walking, although his back legs work in unison, giving him an unusual gait.

"I used to make fun of him, saying he walks like a drunken sailor," said Oscar's owner, Dan Paulin of Boonville, Ind. "I don't think he'll ever be normal, but at least he's not confined to the wheel cart."

In the study, 19 paraplegic dogs were injected with polyethylene glycol, or PEG - a nontoxic liquid polymer composed of long strings of the same type of molecules found in antifreeze.

Within eight weeks, 13 of the 19 canines, about 68 percent, regained the use of their hind legs and were able to walk, some almost as well as before their injury.

The dogs were injected twice with PEG, first soon after their owners brought them to the researchers' labs and then after standard surgery and steroids to reduce inflammation.

Among a group of 24 dogs that received just the standard surgery and rehabilitation therapies, only about 25 percent regained the same level of mobility, feeling and bodily functions, with about 62 percent remaining paraplegic.

The study's findings appear in the December issue of the Journal of Neurotrauma.

Scientists at Purdue, Indiana University's Indianapolis campus and Texas A&M University took part in the research on dogs ages 2 to 8 between 2001-03.

Richard Borgens, the Purdue professor of neuroscience who oversaw the study, said his West Lafayette, Ind., lab had previously used PEG to repair damaged spinal cords in guinea pigs with about a 90 percent success rate.

His team has even fused severed guinea pig spinal cords using PEG, although the dogs in the study had spinal disc ruptures that crushed, but did not sever, their spinal cords.

Although exactly how PEG works remains unclear, Borgens said it appears to act as a sort of "molecular Band-Aid" that forms a temporary seal over breaches in nerve cells in the spinal cord, aiding their healing process.

"This stuff is kind of like a radiator stop-leak for the nervous system. The polymer spreads out and forms a seal over the damaged areas in the nerve cells and allows the membrane below to reconstruct itself," said Borgens, director of Purdue's Center for Paralysis Research.

He said PEG also appears to prevent secondary tissue death that often causes more damage than the original injury. Borgens said the agent only covers damaged cells and tissues when injected into the blood stream.

Purdue has enlisted a yet-to-be-announced corporate sponsor that will make PEG in a form suitable for human clinical trials. Pending federal approval, Borgens hopes those trials can begin within about 18 months on people with hours-old or days-old spinal injuries.

W. Dalton Dietrich, the scientific director of The Miami Project To Cure Paralysis, said the rapid improvements in the dogs are intriguing, but point to the need for follow-up work to learn more about how PEG works and evaluate its safety. "Although the results are very provocative, additional studies are required," he said.

Karen Kline, an associate professor of neurology and neurosurgery at Iowa State University's College of Veterinary Medicine in Ames, Iowa, called the findings promising. She said PEG, which she plans to test on dogs at her lab, appears to stabilize damaged tissue to allow more rapid healing than typically occurs naturally.

"It has such promise, but I think we need to look at more animals and make sure that we're getting a positive outcome," Kline said.

__

On the Net:

Purdue Center for Paralysis Research: http://www.vet.purdue.edu/cpr/
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looks like peg study is not going to be properly randomized

Postby malernee » Sun Dec 05, 2004 6:28 pm

--------------------------------------------------------------------------------

December 3, 2004

Purdue research offers hope for canine, human spinal injuries
WEST LAFAYETTE, Ind. – A successful method for healing spinal injuries in dogs has been developed by Purdue University researchers, offering hope for preventing human paralysis.

Richard Borgens and Kady
Download photo
caption below

Lab tests have shown that an injection of a liquid polymer known as polyethylene glycol (PEG), if administered within 72 hours of serious spinal injury, can prevent most dogs from suffering permanent spinal damage. Even when the spine is initially damaged to the point of paralysis, the PEG solution prevents the nerve cells from rupturing irrevocably, enabling them to heal themselves.

"Nearly 75 percent of the dogs we treated with PEG were able to resume a normal life," said Richard Borgens, Mari Hulman George Professor of Applied Neuroscience and director of the Center for Paralysis Research in Purdue's School of Veterinary Medicine. "Some healed so well that they could go on as though nothing had happened."

The research, performed at Purdue, Indiana University—Purdue University Indianapolis, and Texas A&M University, appears in the December issue of the Journal of Neurotrauma.

In the study, 19 paraplegic dogs between 2 and 8 years of age were treated with a PEG injection within 72 hours of their injury as an addition to the standard veterinary therapy for spinal injury. This standard treatment includes injection of steroids, physical rehabilitation with swimming, and surgical removal of any offending chips of bone remaining in the spinal area after injury. This group of 19 was compared with a second group of 24 dogs that received only the standard treatment.

"The control group was taken from historical cases of dog injury that were similar to those in the 19 dogs we treated," Borgens said. "We didn't want to tell any owners who walked in with injured dogs that their pets were not going to receive something that might help. So we looked at the results that the standard treatment had on dogs that had suffered similar injuries in the past."

After treatment, the dogs' improvement was measured based on criteria including desire to move, deep and superficial pain perception, and transmission of electrical impulses through the nerve tissue.

"More than half of the dogs in this study were standing or walking within two weeks of treatment," Borgens said. "In most cases, you could usually notice positive signs within three to five days."

Another 16 dogs were injected with a different substance called P-188, a mixture of 80 percent PEG along with other chemicals, which also was thought to have potential as a treatment.

"However, dogs treated with the P-188 mixture did not perform as well as those treated with PEG," Borgens said.

Trauma to nerve cells causes their membranes to weaken and even rupture. Though the cells may survive, this membrane damage causes them to lose the ability to produce and carry nerve impulses along their membranes from one cell to the next.

"Worse yet, chemicals seeping out of the dying spinal cord cells send a 'suicide signal' to other nearby cells, causing a chain reaction that kills off more cells than the initial injury did," Borgens said. "Until now, the end result has been irreparable damage to the spinal cord, causing partial or complete paralysis to the victim."

PEG is able to intervene in this process by repairing the initial membrane damage. It has been known for decades that two cells that touch each other can become one big cell if PEG is added to the fluid they live in. Because of this surprising ability, PEG is sometimes called a "fusogen."

About five years ago, Borgens and his partner, Riyi Shi, found that they could actually fuse hundreds to thousands of severed nerve fibers of the guinea pig spinal cord with only a two-minute PEG treatment. This observation led to developing the polymer as a repair agent that would mend the broken membranes of nerve cells after traumatic injury.

Though PEG's action as a fusogen has been known prior to their work, the exact mechanism that occurs at the membrane to fuse or mend it is still poorly understood. Borgens said that many membrane specialists believe it has much to do with the ability of PEG to quickly and dramatically remove water from the cell membrane that floods into the cell after suffering damage. This makes it difficult for the cellular membrane to heal on its own.

"Imagine children blowing bubbles with wands, the kind with a small round hole at the end," Borgens said. "The polymer acts like a soap film that covers the hole and draws the water away. In the PEG-sealed membrane, the fatty oils that form the center of the membrane can mix again, free of the water that had likely repelled them. Once PEG dissolves away from the area, water molecules once again help to induce and preserve the restructured membrane."

In spite of the fact that the exact mechanism is yet to be completely understood, Borgens said it is known that PEG has been both injected and ingested by humans as a component of other medicines and is completely safe. Curiously, PEG only covers damaged cells and tissues when injected into the blood stream and is not found in healthy or undamaged tissues nearby. These facts paved the way for clinical testing on paraplegic dogs at Purdue's School of Veterinary Medicine by Dr. Peter Laverty and his colleagues, and on paralyzed dogs at a partner institution, the Texas A&M College of Veterinary Medicine, by neurologists Joan Coates and Robert Bergman. These efforts could mean relief for many dogs that are prone to spinal injury.

"Certain dog breeds can easily injure their backs simply by jumping off a couch," Borgens said. "Up to this point, little could be done for dogs or humans with such injuries – even with immediate attention and the highest standard of care. Decompression surgery and injections of steroids, like methyl prednisone, have done little."

However, with Borgens' and Shi's discovery of PEG's effects on crushed spinal cord tissue, a new and safe therapy may be even closer to human trials since naturally injured dogs responded so well to it.

"In most dogs, we found a PEG injection within 36 hours can restore sensitivity and even mobility within three weeks," Borgens said. "These results are unprecedented in paralysis research."

While such news should be inspiring for pet owners, Borgens strongly cautions those who think a cure for human paralysis is right around the corner.

"There are significant differences between canine and human spinal cords that must be addressed before this treatment can be applied to people," Borgens said. "In dogs, for example, some of the control of walking actually takes place in the spine, while in humans all of this control resides in our brains. Additionally, PEG cannot just be used off the shelf – it must have a high level of purity for it to be effective. This is very promising research, but it won't be available in your hospital for some time."

On the other hand, once these issues are ironed out, Borgens said the next step would be human trials.

"We do not anticipate this treatment to have any significant effect on people who have suffered from spinal injuries in the past," he said. "But once it is refined, we hope it will prevent future spinal injuries from paralyzing victims permanently. I would like a supply of PEG to become standard on every ambulance."

Funding for this research has been provided by grants from the National Institutes of Health, the state of Indiana and the Mari Hulman-George Endowment.

Purdue's Center for Paralysis Research was established in 1987 to both develop and test promising methods of treatment for spinal cord injuries.

In addition to work with PEG, the center has a number of other ongoing research projects. Borgens also oversees work with oscillating field stimulators, devices that stimulate growth of spinal cord tissue by means of electrical fields. The center also is working with another druglike ingested substance called 4-aminopyridine, which has shown potential in reversing the injury-induced loss of nerve potentials in damaged nerve fibers.

Writer: Chad Boutin, (765) 494-2081, cboutin@purdue.edu

Source: Richard B. Borgens, (765) 494-7600, cpr@purdue.edu

Purdue News Service: (765) 494-2096; purduenews@purdue.edu



PHOTO CAPTION:
Richard Borgens, director of Purdue University's Center for Paralysis Research, helps paralyzed dogs like Kady walk again with the help of treatments like polyethylene glycol (PEG) injections. In a recent study, more than half of the paralyzed dogs that received injections of the PEG polymer within 72 hours of traumatic spinal injury were standing or walking again within weeks. (Photo courtesy of North Texan magazine)

A publication-quality photograph is available at http://ftp.purdue.edu/pub/uns/+2004/borgens-PEG.jpg




--------------------------------------------------------------------------------


ABSTRACT

A Preliminary Study of Intravenous Surfactants in Paraplegic Dogs Polymer Therapy in Canine Clinical SCI


Peter H. Laverty, Alenka Leskovar, Gert J. Breur, Joan R. Coates, Robert L. Bergman, William R. Widmer, James P. Toombs, Scott Shapiro, and Richard B. Borgens

Hydrophilic polymers, both surfactants and triblock polymers, are known to seal defects in cell membranes. In previous experiments using laboratory animals, we have exploited this capability using polyethylene glycol (PEG) to repair spinal axons after severe, standardized spinal cord injury (SCI) in guinea pigs. Similar studies were conducted using a related co-polymer Poloxamer 188 (P 188). Here we carried out initial investigations of an intravenous application of PEG or P 188 (3500 daltons, 30% w/w in saline; 2ml/kg I.V. and 2ml/kg body weight or 300ml P 188 per kg respectively) to neurologically complete cases of paraplegia in dogs. Our aim was to first determine if this is a clinically safe procedure in cases of severe naturally occurring SCI in dogs. Secondarily, we wanted to obtain preliminary evidence if this therapy could be of clinical benefit when compared to a larger number of similar, but historical, control cases. Strict entry criteria permitted recruitment of only neurologically complete paraplegic dogs into this study. Animals were treated by a combination of conventional and experimental techniques within ~ 72 hours of admission for spinal trauma secondary to acute, explosive disk herniation. Outcome measures consisted of measurements of voluntary ambulation, deep and superficial pain perception, conscious proprioception in hindlimbs, and evoked potentials (somatosensory evoked potentials; SSEP). We determined that polymer injection is a safe adjunct to the conventional management of severe neurological injury in dogs. We did not observe any unacceptable clinical response to polymer injection; there were no deaths, nor any other problem arising from, or associated with, the procedures. Outcome measures over the 6 - 8 week trial were improved by polymer injection when compared to historical cases. This recovery was unexpectedly rapid compared to these comparator groups. The results of this pilot trial provide evidence consistent with the notion that the injection of inorganic polymers in acute neurotrauma may be a simple and useful intervention during the acute phase of the injury.



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Cochrane systematic review FOR disc disease TREATMENT

Postby GUEST » Fri Jul 29, 2005 8:02 am

SPONDYLOSIS DEFORMANS

General Information
Spondylosis deformans is a disorder of dogs and cats characterized by
development of bony spurs (osteophytes) on the ends of the vertebrae (bones of the
spine). These bony spurs may form on one or more vertebrae. When they occur
on neighboring vertebrae, these vertebrae may eventually fuse together
(ankylose). Osteophyte production is progressive and both their number and size
increase with age. The most likely location of spondylosis is in the vertebrae
from the lower chest to the pelvis. While all breeds of dogs are susceptible,
the incidence of spondylosis is higher in larger breeds of dogs.
Investigators believe that osteophyte production is a result of degenerative
changes in the intervertebral disks, the flexible fibrous connections
between the vertebrae. Vertebral osteophytes may also form as a result of
instability between adjacent vertebrae.
While many pets with spondylosis do not show any signs, some affected
animals have pain and/or lameness. In severe cases, spinal cord damage is evident.
Stiffness, difficulty in getting up, and pain in the lower back are the most
common signs.


Gibson JNA, Waddell G, Grant IC.

ABSTRACT

------------------------------------------------------------------------------
--

A substantive amendment to this systematic review was last made on 01
November 1998. Cochrane reviews are regularly checked and updated if necessary.
Background: This section is under preparation and will be included in the
next issue

Objectives: Degenerative conditions affecting the lumbar spine are variously
described
as lumbar spondylosis or degenerative disc disease (which we regarded as one
entity) and are associated with back pain, instability, spinal stenosis and
degenerative spondylolisthesis. The objective of this review was to assess
the effects of surgical interventions for the treatment of degenerative lumbar
spondylosis.

Search strategy: We searched the Cochrane Controlled Trials Register,
Medline, Embase, Biosis, Dissertation Abstracts, Index to UK Thesis, and reference
lists of the retrieved articles and we corresponded with experts.

Selection criteria: Randomised or quasi-randomised trials of surgical
treatment of lumbar spondylosis

Data collection and analysis: Two reviewers assessed trial quality and
extracted data from published papers. Additional information was sought from the
authors if necessary.

Main results: Fourteen published trials of all forms of surgical treatment
for degenerative lumbar spondylosis were identified. There were many serious
weaknesses of trial design, including poor methods of randomisation, lack of
blinding and lack of independent assessment of outcome which at times gave
considerable potential for bias. Most of the published results were reporting on
technical surgical outcomes with some crude ratings of clinical outcome, but
few patient-centred outcomes of pain, disability or capacity for
work. There was a particular lack of long-term outcomes. This review found
no published trials comparing any form of surgery for degenerative lumbar
spondylosis compared with natural history, placebo, or any form of conservative
treatment. Nine trials randomly compared instrumented and non-instrumented
fusion. Instrumented fusion produced a higher fusion rate (though that needs to
be qualified by the difficulty of assessing fusion in the presence of
metal-work) but did not improve clinical outcomes and there is evidence that it may
be associated with higher complication rates. The few and heterogeneous
trials on spondylolisthesis, spinal stenosis and nerve compression permitted very
limited conclusions.

Reviewers' conclusions: There is no scientific evidence about the
effectiveness of any form of
surgical decompression or fusion for degenerative lumbar spondylosis
compared with natural history, placebo, or conservative treatment.


Citation: Gibson JNA, Waddell G, Grant IC. Surgery for degenerative lumbar
spondylosis (Cochrane Review). In: The Cochrane Library, Issue 1, 2000.
Oxford: Update Software.
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nyt article Spinal Cement Draws Patients And Questions

Postby guest » Sat Aug 27, 2005 5:37 pm

Spinal Cement Draws Patients And Questions

By GINA KOLATA
Published: August 28, 2005
It used to be that a patient with osteoporosis who broke a vertebra was pretty much out of luck. The only recourse was wearing a back brace and waiting to heal. If the searing pain was unbearable, it could be blunted with powerful narcotics.

But in the past few years, doctors have been offering and patients demanding what some call a miraculous treatment: vertebroplasty (pronounced vur-TEE-bro-plasty), in which a form of cement is injected into the broken spinal bone.

No one is sure why it helps, or even if it does. The hot cement may be shoring up the spine or merely destroying the nerve endings that transmit pain. Or the procedure may simply have a placebo effect.

And some research hints that the procedure may be harmful in the long run, because when one vertebra is shored up, adjacent ones may be more likely to break.

But vertebroplasty and a similar procedure, kyphoplasty, are fast becoming the treatments of choice for patients with bones so weak their vertebrae break.

The two procedures are so common, said Dr. Ethel Siris, an osteoporosis researcher at Columbia University, that "if you have osteoporosis and come into an emergency room with back pain from a fractured vertebra, you are unlikely to leave without it." She said she was concerned about the procedures' widespread and largely uncritical acceptance.

In three years, the number of vertebroplasties nearly doubled, to more than 27,000 in 2004 from 14,000 in 2001. Despite the lack of rigorous evidence that the procedures work, most were covered by Medicare, at a cost of $21 million last year. (There is even less data on the effects of kyphoplasty, which involves pumping the vertebra with a balloon to restore its shape before injecting cement.)

Even proponents would like to know whether cement injections really help in the long run, but medical scientists fear they may never know.

In 2002, a group of researchers received a federal grant for a clinical trial that would be the first to rigorously assess vertebroplasty. But their study is faltering.

Patients in severe pain have proved unwilling to enter such a trial, in which they might be randomly assigned to get a placebo, and their doctors have been reluctant to suggest it. In 18 months, the investigators have been able to persuade just three medical centers to recruit patients, and only three patients have enrolled.

Now the investigators are looking for centers overseas, but they agree that the study's prospects are dim and that its failure would leave critical questions unanswered.

"Whose responsibility is it to decide that something should be part of medical practice without adequate evidence that it works?" asked Dr. Jeffrey G. Jarvik, an investigator with the study and a neuroradiologist at the University of Washington.

But for many doctors, the time to ask is long past. Whatever the evidence, they say, too many people are convinced that the procedures work.

"I struggle with this," said Dr. Joshua A. Hirsch, director of interventional neuroradiology at Massachusetts General Hospital in Boston. He believes in clinical trials, he said, but when it comes to vertebroplasty and kyphoplasty, "I truly believe these procedures work."

"I adore my patients," Dr. Hirsch added, "and it hurts me that they suffer, to the point that I come in on my days off to do these procedures."

Vertebroplasty came to the United States in 1993 when Dr. Mary E. Jensen and Dr. Jacques E. Dion, interventional neuroradiologists at the University of Virginia Health System, were confronted with a woman with breast cancer that had spread to her spine. Conventional medicine had nothing to offer for her excruciating, unrelenting pain.

But they remembered a lecture by a French doctor who said she had injected a form of cement into the vertebrae of cancer patients and said it relieved their pain. She did not, however, explain how to do it.

So Dr. Jensen and Dr. Dion began mixing up various concoctions of polymethylmethacrylate, a cement approved by the Food and Drug Administration for attaching bone to implants. (Surgeons can try new procedures without F.D.A. approval and can use approved substances in new ways at their discretion.)

"We've never tried this before," Dr. Jensen said they told the cancer patient. "But it's all we have to offer." With trepidation, they injected the cement.

"The next day," Dr. Jensen said, "her pain was gone."

Then they saw two men with severe compression fractures of the spine caused by osteoporosis. After practicing on spines from cadavers, the two doctors treated the men with cement. Again, their pain went away.

"We said, 'O.K., now we may actually be on to something,' " Dr. Jensen recalled. In November 1997, she and her colleagues reported on 29 patients. Twenty-six, they said, "reported significant pain relief immediately after treatment."

Dr. Jensen was won over.

"Anyone who goes from a pain scale of nine to a pain scale of two within 48 hours, I'm sorry, but I just do not believe it is a placebo or natural history," she said. "These were people who had been in unremitting, relentless pain for weeks."

Wanting to get the procedure to more patients, Dr. Jensen asked established companies to make the cement mix. They refused, so she and Dr. Dion joined forces with a biomedical engineer to found their own company. She trained hundreds of doctors in weekend sessions. And she and her colleagues lobbied local insurance carriers with Medicare contracts to pay for the technique.

"Four years ago, we were the only hospital in a 100-mile radius to offer it," Dr. Jensen said. "Now all the community hospitals offer it."

But Dr. David F. Kallmes, one of her partners, wanted a rigorous test. He began a pilot study, randomly assigning participants to vertebroplasty or placebo. To make it more appealing, he told patients that 10 days later they could get whichever treatment they had failed to get the first time.

It was hard to find subjects, and Dr. Kallmes ended up with only five. For the sham procedure, he pressed on the patient's back as if injecting cement, injected a local anesthetic, opened a container of polymethylmethacrylate so the distinctive nail-polish-remover smell would waft through the air and banged on a bowl so it sounded like he was mixing cement.

In 2002, he reported his results: three patients initially had vertebroplasty and two had the sham. But there was no difference in pain relief. All the patients thought they had gotten the placebo, and all wanted the other treatment after 10 days. One patient who had vertebroplasty followed in 10 days by the sham said the second procedure - the sham - relieved his pain.

That experience convinced Dr. Kallmes that it was possible, and important, to do a larger randomized trial, so he won a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases for the study that is under way. Dr. Kallmes, now at the Mayo Clinic, said he had high hopes for vertebroplasty but recognized that reports of its effectiveness might be misleading.

"There are a number of biases in the procedure and in the way the data is collected," he said. Previous studies, he said, have "mostly been done by people like me without a background in statistical methods."

For example, he said, patients come in crying for relief when their pain is at its apogee. By chance, it is likely to regress whether or not they are treated. That phenomenon, regression to the mean, has foiled researchers time and time again.

And there are other questions, said Mary Bouxsein, a bone biomechanics researcher at Harvard Medical School. One study, by Dr. Terrence Diamond of St. George Hospital in Sydney, Australia, found that after six weeks, patients who had vertebroplasty had no better pain relief than those who did not.

So are vertebroplasty and kyphoplasty worthwhile in the long run?

"When you think about what's in the spine, it's vertebral bodies with disks in between," Dr. Bouxsein said. "The disk is like a little spring that absorbs load.

"When you put cement in there," she continued, "you change the biomechanics of how the load is transferred, and that increases the stress on the vertebrae above and below. In an osteoporotic patient who is already at risk for spine fracture, that may not be what you want to do."

Some small studies have found a suggestion of high fracture rates in vertebrae adjacent to those injected with cement. And Dr. Bouxsein and others, testing spines from cadavers, found they fractured more easily if one of the vertebrae was filled with cement. "It's a tough issue," Dr. Bouxsein said. If a patient gets profound and immediate pain relief, that alone may make the procedure worthwhile, she said. Or, then again, it may not.

Patients tell a variety of stories, not all with happy endings.

Jacqueline Gosselin, 76, of Winslow, Me., was consumed with pain after two of her vertebrae collapsed. She spent weeks in the hospital and was unable to walk for months. Seven months after her injury, she had kyphoplasty.

At first she thought she had improved, she said, but "I've gone downhill ever since." The pain is now about the same as before the procedure, she said, adding, "I'm still looking for help."

An osteoporosis patient, Stanley Stanton, a 58-year-old foreman in Owatonna, Minn., broke vertebrae by simply twisting his torso one day this spring. The pain was so bad that he could hardly walk. But after vertebroplasty, he said, "I walked out of there two hours later and I was 300 percent better." That was in June; today he needs only an occasional over-the-counter pain reliever.

Doctors say they have seen patients who got no relief. But what really popularized the procedure, they say, were unforgettable stories of people like Mr. Stanton with unbearable pain who got their lives back.

Dr. Jensen knows firsthand how powerful such stories can be. In the late 1990's, when vertebroplasty was new and many doctors were looking askance at it, she gave a talk to a group of doctors in Chicago.

"I could tell by looking at the audience that no one believed me," she said. When she finished, no one even asked questions.

Finally, a woman in back raised her hand. Her father, she told the group, had severe osteoporosis and had fractured a vertebra. The pain was so severe he needed morphine; that made him demented, landing him in a nursing home.

Then he had vertebroplasty. It had a real Lazarus effect, the woman said: the pain disappeared, the narcotics stopped, and her father could go home.

"That was all it took," Dr. Jensen said. "Suddenly, people were asking questions. 'How do we get started?' "

But Dr. Siris, of Columbia, said such astonishing reports were just part of the story. "Clearly, many patients have these procedures and the pain does go away," she said. "But what are the risks to the rest of the spine in terms of more fractures? That's the dilemma.

"It's a technique that's crying out for clinical trials," Dr. Siris went on. But with only patients' stories as evidence, the procedures "are being offered to patients without fair information and without truth in advertising."
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How can disc back surgery help in theory?

Postby malernee » Tue Sep 27, 2005 8:38 am

I was wondering whether rapid decompression back surgery makes any difference in these ruptured disc cases or whether the rapid worsening of signs would happen regardless due to the initial concussive trauma to the cord and the secondary biochemical damaging effects?

The answer is no one knows... Some Inter Vertebral Disc-induced spinal cord injury in dogs could be a combination of compression and concussion. The percentage role played by each is unknowable. De compressive surgery is just that; we are limited to dealing with the compressive component with surgery which cannot yet be measured, while the concussive effects (with the secondary biochemical cascade) are the realm of drugs and Mother Nature. So, if I have a dog with acute and/or rapidly deteriorating signs, and I could demonstrate that there is some element of extra dural compression, then surgery in theory might help. If I knew for sure that there was not significant extra dural mass effect or if I saw clear signs of focal myelomalacia, I would not think operating would help. .

Does that make sense?

For example If there is a tumor pressing on the spinal cord then if it can be removed before it gets bigger that may help. Disk material once in the spinal canal will not get bigger so removing it sooner than the body would naturally may not help because the damage may already be done. If you drop a hammer and it falls and hits your finger removing the hammer quickly from your finger does not help because the damage has already been done to the finger from the concussion of the hammer. However If you slam your finger in a car door, opening the door to let your finger loose and ease the pressure on you finger will help your finger heal. What evidence do we have other than expert opinion that removal of the ruptured disc material from around the spine after the concussion has already occured helps the patient and not just our check book? Sad to say, good properly randomized long term outcome study's have not show a temporal benefit to early disc removal surgery.

http://www.ncbi.nlm.nih.gov/entrez/quer ... query_hl=6

It seems to me if ruptured disc surgery really helps then long term outcome study's would show the quicker we remove disk material from around the spinal cord the better the long term outcome results would be. Since study's show long term results of disc surgery is not better when done sooner I suspect concussive trauma to the cord and the secondary biochemical damaging effects is by far the main problem we must address if we can. If there is a significant combination of spinal cord compression and concussion where disc removal surgery really helps the proof is lacking. In my opinion I think dog back disc surgery should be promoted as investigational or experimental surgical care in the market place by the vet surgical board leaders to avoid promoting unproven medical care in the market place. Let us avoid charges of professional organized quackery.

http://evidencebasedvet.com/forum/viewt ... ?p=735#735

The public is not going to financially support a medical profession run by a band of so called experts that continue in today's healthfraud information age

http://evidencebasedvet.com/forum/viewtopic.php?t=279

to promote unproven medical care in the market place.
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durotomy in dog back surgery

Postby malernee » Mon Nov 28, 2005 9:02 am

Effect of Durotomy on Functional Outcome of Dogs with Type I Thoracolumbar Disc Extrusion and Absent Deep Pain Perception
Vet Comp Ortho Trauma 18[3]:141-146 Aug'05 Retrospective Study 30 Refs

* C. A. Loughin, C. W. Dewey, P. B. Ringwood, R. W. Pettigrew, M. Kent, S. C. Budsberg
* Long Island Veterinary Specialists 163 S. Service Road, Plainview, NY 11803 USA; Email: loughin1@yahoo.com
Spinal card durotomy is performed as a diagnostic aid in determining spinal cord structural integrity, and this may be useful as an indicator of prognosis in cases with lass of deep pain perception (DPP). It has been suggested that a durotomy may relieve intramedullary compression but there is some debate about the therapeutic value. The purpose of this study was to compare ambulatory outcome of dogs that had loss of DPP treated with hemilaminectomy with durotomy versus hemilaminectomy without durotomy. Medical records of 81 dogs diagnosed with type I thoracolumbar IVD were reviewed. Dogs were included in the study if DPP was absent upon initial neurological examination and surgical decompression via hemilaminectomy was performed. Of the 81 cases, 48 were included in this study. The number of dogs that recovered ambulatory function were compared between durotomy and nondurotomy groups with a chi-squared test (p < 0.05). No differences were found. The findings of this study suggest that durotomy is useful as a diagnostic modality and that performing a durotomy does not significantly affect post-operative recovery of voluntary motor function. [Summary]
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Need to Operate on Disk Injuries NYT article

Postby malernee » Wed Nov 22, 2006 12:00 pm

Study Questions Need to Operate on Disk Injuries
Ethan Kaplan for The New York Times
Dr. Eugene J. Carragee of Stanford called the risk of waiting with sciatica “if not extraordinarily small, at least off the radar screen.”



By GINA KOLATA
Published: November 22, 2006
People with ruptured disks in their lower backs usually recover whether or not they have surgery, researchers are reporting today. The study, a large trial, found that surgery appeared to relieve pain more quickly but that most people recovered eventually and that there was no harm in waiting.

The Spine Patient Outcomes Research Trial (SPORT): A Randomized Trial (JAMA)
The Spine Patient Outcomes Research Trial (SPORT) Observational Cohort (JAMA)And that, surgeons said, is likely to change medical practice.

The study, published in The Journal of the American Medical Association, is the only large and well-designed trial to compare surgery for sciatica with waiting.

The study was controversial from the start, with many surgeons saying they knew that the operation worked and that it would be unethical for their patients to participate in such a study.

In the end, though, neither waiting nor surgery was a clear winner, and most patients could safely decide what to do based on personal preference and level of pain. Although many patients did not stay with their assigned treatment, most fared well with whatever treatment they had.

Patients who had surgery often reported immediate relief. But by three to six months, patients in both groups reported marked improvement.

After two years, about 70 percent of the patients in the two groups said they had a “major improvement” in their symptoms. No one who waited had serious consequences, and no one who had surgery had a disastrous result.

Many surgeons had long feared that waiting would cause severe harm, but those fears were proved unfounded.

“I think this will have an impact,” said Dr. Steven R. Garfin, chairman of the department of orthopedic surgery at the University of California, San Diego. “It says you don’t have to rush in for surgery. Time is usually your ally, not your enemy,” Dr. Garfin added.

As many as a million Americans suffer from sciatica, said Dr. James Weinstein, a professor of orthopedic surgery at Dartmouth who led the study. The condition is characterized by an often agonizing pain in the buttocks or leg or weakness in a leg.

It is caused when a ruptured disk impinges on the root of the sciatic nerve, which runs down the back of the leg. And an estimated 300,000 Americans a year have surgery to relieve the symptoms, Dr. Weinstein said.

Patients are often told that if they delay surgery they may risk permanent nerve damage, perhaps a weakened leg or even losing bowel or bladder control. But nothing like that occurred in the two-year study comparing surgery with waiting in nearly 2,000 patients.

The study did not include people who had just lower back pain, which can have a variety of causes. Nor did it include people with conditions that would require immediate surgery like losing bowel or bladder control.

Instead, they were typical of a vast majority of people with sciatica who are made miserable by searing pain. For such patients, fear that delaying an operation could be dangerous “was the 800-pound gorilla in the room,” said Dr. Eugene J. Carragee, professor of orthopedic surgery at Stanford.

Dr. Carragee said that he had never believed it himself, but that the concern was widespread among patients and doctors.

“The worry was not knowing,” he added. “If someone had a big herniated disk, can you just say, ‘Well, if it’s not bothering you that much, you can wait?’ It’s kind of like walking on eggshells. What if something terrible did happen?”

With the new results, it is clear that the risk of waiting “is, if not extraordinarily small, at least off the radar screen,” Dr. Carragee said.

The study involved 13 spine clinics in 11 states. All the participants had pain from herniated disks and leg pain. The patients were asked whether they would allow the researchers to decide their treatment at random. Those who did not have surgery generally received physical therapy, counseling and anti-inflammatory drugs.

In the end, the study could not provide definitive results on the best course of treatment because so many patients chose not to have the treatment that they had been randomly assigned.

About 40 percent of those assigned to surgery decided not to have it, often because their conditions improved while they awaited the operations. A third of patients assigned to wait decided to have operations, often because their pain was so bad that they could not endure it any longer.

Others asked not to be assigned at random and were followed to see what treatment they chose and how they fared.

The researchers are also conducting a separate analysis on the cost effectiveness of surgery compared with waiting. Although that analysis has not been published, Dr. Anna N. A. Tosteson of Dartmouth, an author of the study, said that Medicare paid a total of $5,425 for the operation and that private insurers might pay three to four times that.

Although the results answered one question, about the safety of waiting, they were also, in a sense, disappointing, said Dr. David R. Flum, a contributing editor at The Journal of the American Medical Association and an associate professor of surgery at the University of Washington.

“Everyone was hoping the study would show which was better,” Dr. Flum said.

“And everyone was surprised by the tremendous number of crossovers in both directions,” he added, referring to the large number of participants who changed from surgery to waiting and vice versa.

That muddied the data.

Sciatica tends to run in families and occurs when the soft gel-like material inside a spinal disk protrudes through the outer lining of the disk like a bubble on a bicycle tire. That compresses and inflames a nerve root that forms the sciatic nerve.

The resulting pain can feel like a burning fork in the buttocks, Dr. Weinstein said. Or it can be a searing pain down the back of a leg. The pain can be so intense that some people cannot walk. Some cannot sit. Some, Dr. Weinstein said, “can barely crawl.”

The operation is quick and generally effective, Dr. Garfin said. It involves gently pushing the compressed nerve root away from the herniated disk. Then the surgeon makes an incision in the disk and deflates it. The nerve returns to its normal position, the inflammation goes away, and the pain often disappears.

The Journal of the American Medical Association published two papers on the study, one reporting on the randomized trial and the other on the patients who chose not to be randomized. It also published editorials by Dr. Carragee and Dr. Flum.

The reason for all the attention, Dr. Flum explained, was that the study was large and well designed, that its authors had no conflicts of interest, and, “We can learn a lot.”

The message, in the end, Dr. Weinstein said, was that no matter which treatment a patient received, “nobody got worse.”

He added, “We never knew that until we did the study.”
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