A new hope for back pain sufferers?
(CBS News) Back pain is one of the most common of human complaints, which is why new treatments in the works are raising so many hopes. Our Sunday Morning Cover Story is reported now by Martha Teichner:
Consider the human spine, in all its glory.
The 24 vertebrae, cushioned by gelatinous discs . . . the little facet joints that help make your back flexible . . . all the ligaments and muscles and nerves.
The spine's elegant complexity is a miracle of engineering, or a curse when something goes wrong.
Eight out of ten Americans will experience debilitating back pain sometime in their lives.
"My pain was very excruciating," said Lenda. "I couldn't walk, I couldn't bend over. I couldn't lie down."
"I'd say, 'Oh Lord, can't you help my back, it does hurt bad' - he didn't help me a bit," said Leila.
And the most common culprit?
"I think most people would think it's the inter-vertebral discs, whether it's herniated or whether it's just worn and arthritic and associated with pain," said Dr. Augustus White, a professor at Harvard Medical School. He has literally written the book on lower back pain.
He says the easiest way to understand a herniated disc is to think of a jelly doughnut: When what Dr. White calls "the jelly" gets squeezed out, it presses on nerves, which can mean excruciating pain. Barring serious illness, the first line of treatment may not be what the patient (who only wants a quick fix) wants to hear.
"You need to make sure the patient doesn't have tumor or infection," said Dr. White, "but once you rule those out, you can be confident that you're not going to harm the patient by saying, 'OK, give yourself four to six weeks.'"
Believe it or not, 90 percent of disc injuries heal themselves after a few weeks, especially with physical therapy. But waiting it out can be torture, and not everybody gets better. So that's where surgery comes in.
More than 1.2 million Americans undergo spinal surgery each year. That's more than TRIPLE the number of coronary by-pass surgeries (415,000), and nearly FOUR TIMES the number of hip replacements (327,000).
Approximately 300,000 of those back surgeries were spinal fusions, where vertebrae are joined surgically so they can't move. They're often held in place, permanently, with metal screws or rods.
For many patients, surgery is the only answer - salvation. But for all too many others, it can be a nightmare.
Which brings us to Dr. Kevin Pauza, a founder of the Texas Spine and Joint Hospital in Tyler, Texas.
"I spent decades treating patients who've had surgery, the surgery was fusions," Dr. pauza said. "Patients would do well for a year or two, and they'd always come to me and need more help."
In his experience, fusion was usually the wrong answer: "The spine's made to be a structure that bends with every movement we make, and if we immobilize a segment of the spine, the adjacent segment breaks down. That's known as the domino effect.
"So my thought was, can we do something to that disc so that we don't have to fuse it? Can we bring the disc back to life?"
And that's the headline of this story. Just imagine: A procedure that repairs and re-grows discs, that doesn't involve spinal fusion, that's no more than minimally invasive, outpatient surgery.
The inspiration came to him when he thought about something as basic as how an ordinary cut heals.
"I realized what heals a cut is something that's very simple: It's two products that are in you and I, they're in everybody."
In our blood plasma - they're called thrombin and fibrinogen. For the cut to heal, the two components come together, and they make a substance called fibrin.
When the two components, in concentrated form, are injected into the disc through a kind of squirt gun Pauza invented, just like epoxy glue, they combine and become fibrin.
Injected into the damaged disc, the compound acts like a sealant, filling cracks and crevices, and eventually allowing the disc to re-grow. "It allows our degenerated disc to turn into a young, healthy, normal disc," said Dr. Pauza.
Rusty Templeton is typical of Dr. Pauza's failed fusion patients. He had his surgery in 2008, but the pain came back and was agonizing.
"I've kind of damaged the disc above and below my fusion, and of course that fusion disc is also in pretty bad disrepair," said Templeton.
Templeton is given a local anesthetic. The procedure takes about five minutes...there's no incision..no hardware...
Typically, at first, patients feel discomfort. "Some patients even say, 'Gosh, I wish I never had this done,'" said Dr. Pauza. "And then several weeks later, the patients just turn a corner. We tell them that they can expect that there will be one day where they have pain, and the next day, it'll just stop."
Dr. Pauza is hoping for Food and Drug Administration approval of the procedure by 2015, and to make it available to the public shortly thereafter. Phase III clinical trials are underway now at 20 sites around the U.S.
Dr. Pauza has successfully treated more than a thousand patients in his private practice. "We started treating the first patients approximately five or six years ago, and the success rate is approximately 86 percent," he said.
So how did Rusty Templeton do? "My pain before was at least a ten," he said. And two months after the procedure? "It's still around a five, because I have underlying issues. But I can lay down now. I can, you know, walk around. I can drive where I couldn't drive before.
"The pain level I had before the procedure was probably around anywhere from about a six to worse, eight," he said.
Christopher Joseph is a home restorer who was in a car accident. How was his pain two months after the procedure? "Right now, it's at zero."
Dr. Michael DePalma is a spine specialist in Richmond, Va. The North American Spine Society has just published his paper on the latest experimental therapies involving disc restoration.
"Stem cells are something that's being investigated to replenish cells within the disc directly, injecting growth factors, which are proteins, to try to stimulate repair in a disc have also been evaluated," said Dr. DePalma.
He is involved in 4 different FDA trials of the new procedures and believes these so-called biologics are the future of back treatment. Based on the results so far, he thinks Dr. Pauza's fibrin sealant offers the most promise.
If the treatment, asked Tecihner, is even 50% successful with someone, is that significant? Dr. DePalma replied, "It'd be huge."
And then there's the cost. Compare spinal fusion and fibrin treatment: "The treatment for a fusion - and this is the hospital fee - typically is in the $100,000 range, not including the physician's fee," he said. "We don't have a set cost for [fibrin] treatment yet, but it's approximately 95 percent less than the cost of a fusion."
Dr. Pauza expects it to be widely available within five years.
"It's the first time in history that we've been able to cause new tissue to grow within the spine. This procedure is the procedure that really the world has been waiting for," he said.
Is it? The procedure is only for back pain sufferers with specific disc problems, but there are a lot of those . . . and Dr. Kevin Pauza is absolutely sure he's found a better, safer, cheaper way of improving their lives.
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