A New Hope For Back Pain Sufferers?

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doctors  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.

{CBS News/Matzav.com Newscenter}


15 COMMENTS

  1. I had back surgery and was good for a number of years now I’m having back pain again at about a level 8. I now have L45 severe degeneration of the disc with tears and L5 S1 focal bulge 2mm to 3mm. Had an MRI 4/30/12 Would love to be in on trials of this procedure. I live in California but would travel. Thank You Robert Colt

  2. I have degenerative disk desease.I am 72 in excellent health.I would love to participate in your program. 860-7496652 I haven’t had any surgery.

  3. I have degenerative disc disease and have not had surgery. I am near bone to bone and the pain never goes away. It’s something I have lived with since I was in high school. I’m now 60 and love to play golf. I spend time every round loosening up my back so I can play. This procedure sounds like the answer to my problem. Is it possible to be in one of your trials? I live Greenville, NC and my cell # is 252-341-5888.

    Thanks for considering me for this trial.
    Henry Harris

  4. I have had a L5S1 Fusion and herniated my disc between T7 and T8. This occurred 3 months after my fusion. It has affected my entire spine. Can the procedure of injectint the fibrin and thrombin be performed in the thoracic area? [email protected] 409-749-4235

  5. My husband, Kendel Hebner had a fall from his eighteen-wheeler in 2005 and was told the only thing available to him was the fusion this article talks about. He now has pain constantly and it has changed him. Would this fibrin and thrombin procedure help him. We will gladly travel to you as we are full-time RV’ers. My e-mail is [email protected] and phone number (716) 485-1727 at any time. Thank you for consideration!

  6. i would like to know what the specific disc problems this is geared to. I have had L5S1 and T3 lamis, no fusion. have had numbness in left leg for a couple years now. have been told arthritis in L4 could go anytime. Please advise as i will be looking at further surgeries if your procedure is not available. thank you. 607-648-3955

  7. I’m 37 year old ,i have 4 discs with hernia , the hernia is located in my low back,i have this pain since 18 years old and the pain never goes away i never had surgery,i would love to be in on trials of this procedure, i live in connecticut , but i can travel, my number 203 449-5194 or 203 948-4528 ,thank you for consideration

  8. I’m 63 year old with anterior fusion at L1/L2 and posterior fusion at L4/L5 . I have had pain since 1989 . It is constant and mostly back pain. I would love to be on this trial procedure. I live in woburn ma. But will travel to anywhere in the world in a second. My number is 781 933 8893 or 781 850 6330 . My email is [email protected]
    Thank you
    Greatly appriciated
    David conley

  9. I am 85 years old and have had painfull disk deteriation for the last seven years. I used to be 6 foot 4 inches in height but have shrunk to 5 feet 11 inches due to disk deteriation. I am in constant pain and would like to participat in Dr, Pauza’s fibrin trial procedure. I live in California near Pasadena. My email is [email protected].

  10. The article speaks about performing this procedure for degenerating disks in the back. Would this procedure be applicable to the neck as well? My c5 disk is pressing against a nerve causing pain in my neck and right upper back and shoulder area. My orthopedist has recommended surgery to remove the disk and replace it with bone from my hip. The bone would be put in some sort of “cage” and fused in. I welcome your thoughts on this.

  11. I’m a recently retired Firefighter. I have L-5 S-1 disc damage. I need help.
    I live in So. California. Can you please help me now? thank you

    Daniel Ramirez
    949-429-8273

  12. I have degenerating disks and they are herniated L/4 L/5. I found out about this a couple months ago after I was Told to have surgery.I am in to much pain for a 32 year old. I cant even pick my 3 year old son up. Please Please let me know if I could get in on the trails. [email protected]

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