Sunday, May 6, 2012

My Aching Back

If you did not have an opportunity to watch The Sunday CBS Morning Show, an expose highlighted the ongoing work at the Texas Spine and Joint Hospital located in Tyler, Texas featuring Dr. Kevin Pauza. For those not familiar with Dr. Pauza, he is working with fibrin a combination of thrombin and fibrinogen found in our own body as an alternative modality of treatment for certain back ailments?  What jumps out is the staggering differences in the number of surgical procedures that are performed in spine compared to coronary heart disease and hip replacements.

Regardless whether 90% of disc injuries heal themselves, the numbers speak volumes about the politics of spine surgery and healthcare in the United States.  It was reported that 1.2 million spine procedures are performed annually, three times the number of coronary procedures and four times the number of hip replacements. A third of those spine procedures were fusions.  In the opinion of Dr. Pauza fusion in many instances is the wrong answer.  But the question must be asked, what if Dr. Pauza's work substantiates his hypothesis regarding a cocktail of thrombin and fibrinogen? What happens if one can regenerate the disc without surgical intervention?  Surely, the usual suspects or skeptics will say other wise, especially, if they have done a tremendous job lining their coffers on the back of pedicle screws and inter-body devices.

What is encouraging is that Dr. Michael DePalma of Richmond, Virginia believes that the ongoing efforts of those surgeons working with stem cells or those that are involved with the fibrin study could alter the way patients with back pain are treated.  What we did learn is that there are 20 facilities across the United States that are currently involved with the study with a success rate of 86%.  Dr. DePalma's observations were that even if the fibrin works on 50% of the patient that this will be a major breakthrough.  TSB is sure that the naysayers that are sitting around selling pedicle screws will attempt to throw some cold water on this post, or on the work that surgeons like Dr. Pauza are doing, but you know one way or another you can't make everyone happy.

So the question that TSB must ask our readers, are we looking into the crystal ball of spine?  Who needs a vending machine or POD, all you have to do is identify a material that will regenerate the spine and all our troubles are over.  Is the future now?  TSB wants to know what our readers think, could this Delorean be taking us to the future?


63 comments:

  1. This is just another PRP venture, made popular by people like Tiger Woods, etc etc. There is no science nor data to support this, not in the elbow, knee, nor shoulder. It is a shame that the press is jumping on this and selling the snake oil for these hucksters. Keep in mind, the placebo effect can be strong and there are many NONspine reasons for axial pain. The placebo effect may be even stronger for nonoperative interventions for axial pain.

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    1. The fibrin answer by Kevin Pauza possesses objective, scientific evidence. Read the controlled study done at the University of California, which won tge NorthvAnericsn Spine Study Outsyanding Study of the Year, before your misinformation lumps the Pauza fibrin disc bioligic with other things such as prp, etc. The pauza outstanding study of the year by NASS validated the science. He is available to d us cuss the data.
      Reslectfully

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    2. A Randomized, double blind Investigation was successfully done by Kevin Pauza MD, and could be done for any other surgical spine procedure. The follow up investigator would be blinded to wether the subject underwent the fusion or not. Because of the real numbers of patient deaths and morbidity associated with fusions and disc replacements, any IRB Board should adopt the Pauza Protocol for Spine Surgery. A single study would serve to decrease morbidity and mortality, while saving billions of dollars. Common sense often seems lacking in government and medical industry.

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    3. Naysayers like you should talk to people like me who have had this procedure and put years of horrible back pain behind them as a result! Snake oil? Hardly! Do your homework before putting yourself out there! You remind me of a flat earther!

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    4. Trolls like you should stay away from important conversations like this where people's health and wellbeing are concerned! Many people have had this procedure and overcome their backpain and as one of Dr Pauza's patients, I can attest to the fact this is neither snakeoil nor placebo! It's a shame people like you find it necessary to rain on every parade you can find and present yourself as a stumbling block to hope for people who are suffering and have finally found a solution to their problem!

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  2. Who are you and what have you done with tsb

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  3. Actually, it is an FDA, randomized, double blind, placebo controlled Phase three study. This is more than any spine survey can claim.

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  4. The Kevin Pauza Spine Disc Biological Fibrin study is for real. Pauza has a method to reverse degenerative disc disease, according to the FDA results. I read the FDA Website. Pauza is doing spine research that deserves the Nobel Prize in Medicine. Shame on those naysayers who can't substantiate their facts, like Pauza has substantiated his finding.ga in the most scientific manner.
    Pauza should teach the spine hardware companies how to do research. Pauza research has nothing to do with PRBC.

    According to the FDA, Kevin Pauza has headed a multicenter, randomized, double blind, placebo controlled study. Pauza should replace Dr. Oz, then people will know the difference between good medicine and the converse.

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  5. PRBC and PRP are totally different, that you have correct. The XStop study was "for real" too. PRP/Fibrin injections are nothing new, this guy was first to get his name out there for spine. Do some reading on lateral epicondylitis etc etc and read what nonconflicted experts have to say about the stuff. This is good for Pauza et al though. You need to have a worthless, damaging discogram first (that they will get paid for) then get paid to squirt a clot in your disc.

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  6. Even if the treatment has a 40% success rate that will be better than a bunch of POD sponsored me to implants.

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  7. I wonder if there is a parallel method for arthritic knee joints

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    1. check out Dr. Broyles at the bone and joint clinic. I've had surgery along with the stemcell and PRP injections to grow new cartilage in both of my knees. His website is: http://cartilageregenerationcenter.com/

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  8. I also read that Dr Kevin Pauza has Patented a Similiarly method to regenerate knee and hip cartilage utilizing a Similiarly biological.
    The best inventions, like the light bulb, and like the Pauza Invention are simple. Kudos to Dr Pauza for stepping beyond surgery and the PRBC to something validated scientifically in a rigorous manner. Pauza also has no financial incentive for his work.

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  9. Pauza, IDET study! Enough said, hope it works.

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  10. Kevin Pauza would win the Nobel prize in Medicine, but Pauza is not supported by the financial goons of wall street, so his work is best, but he will not get the recognition he deserves.

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  11. Pauza is an investor in the company that has "designed" the delivery device. He has everything to gain from this. I doubt this is disclosed anywhere in the media promotion. Wall Street will support anything that will give them a buck. Time will tell, but you guys need to do some more homework. And surgery is not the answer for "annular tears" either, so please don't think I am advocating that. If it works better than nonoperative care, I will be happy to add it to my aresenal. Until then, this is bunk just like PRP injections for any other joint or -itis.

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    1. Pauza 's minimal ownership is completely disclosed everuwhere.
      It makes sense the inventor should have ownership. Would YOU criticize Criticize Bill Gates, Steve Jobs, or Henry Ford for also having ownership in their inventions. Please don't be jealous of those geniuses.

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  12. To the guy impressed with the "FDA, double blind" study - all randomized trials MUST be registered with the FDA to be published in any journal worth it's salt. In the methods, one must include the registration number. Without this registration, you have an unpublishable work. I would LOVE to hear how you'd propose a "double blind" study for surgery and get it past an IRB. "The surgeons will be blinded as to whether or not they are actually performing surgery."

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    1. It's easy to double blind a surgical study and has been done before. Learn the facts before you comnent.
      The fusion hardware companies refused to offer to do the study equal to the quality of the Kevin Pauza Placebo Controlled spine studies.
      Here is how....do an incision on all. In some do the treatment and suture close. In others suture close without doing anything internally. Then simply have all the follow ups done by another surgeon.
      Simple. And if one doesn't understand that, then they are not intelligent (respectively) to understand the simplest research.

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  13. 23 years of severn cronic back pain and not enough nerve to go under the knife one more time...I WANT TO KNOW...where do I sign up for this study?!?!!

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  14. So is Yuan in Pioneer, MacClellan in Custom Spine, Asdourian in VTI. and the list goes on, so does that mean that Pauza shouldn't be able to invest in something that he is working on and believes in. Ar least he's not calling up investors begging for them to pump money into another me too company.

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  15. Sorry, PRP is just another me too. He is free to invest in it, but it should be disclosed, so that people like 11:07 don't think that there is not considerable financial gain for promoting this. Look at the comments on the websites with this write up, people clamoring to get in to the trial now. McClellan's comments on why he supports that crazy articulated thing make no sense, from the OTW website. Larger footprint = POSSIBLY higher fusion rates - improved HRQOL scores? Not sure, maybe. Make no mistake, Yuan is one of the guys who will sign up for whatever crosses his desk.

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  16. TSBs commission from this article is going to make the rest of us look like amateurs.

    There, I said it!

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  17. When you work at Nuvasive..you become angry;
    when you become angry..you go to the gyn for some racketball;
    when you play racketball..you get injured;
    when you get injured..you get a patch on your eye;
    when you get a patch on your eye..thugs think you're tough;
    when thugs think you're tough..they want to find out how tough,
    and you end up in a roadside ditch.
    Don't end up in a roadside ditch..don't work at Nuvasive!

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    1. You couldn't get a job with NuVasive if your life depended on it. Alphatec on the other hand...

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    2. When you work at Nuvasive, you probably have a consultant surgeon using your product.
      When consultant surgeon gets offered more by Lanx, you again end up in roadside Ditch...
      And prey that you can go back to pharma!

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    3. Nuvasive is a house of cards..smoke and mirrors..you pick. The Nuvasive reps in my area can't find their a** with both hands. Never wanted to work at Nuvasive..wouldn't want the cut in pay..can't drink that koolaid.

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    4. When you work at Depuy you get your doc a nice deal
      When your doc gets a nice deal you begin to make over 400K a year
      when you make over 400K a year you get cocky and start buying expensive cars and fancy homes
      when you buy fancy, expensive things you need more income
      when you need more income you start pressing docs too hard
      when you press docs too hard they get sick and tired of you
      when docs get sick and tired of you they start avoiding you
      don't have docs avoid you, don't be a consultant based rep

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  18. MSK Man - sometimes you sound insightful, while at other times, like in this posting, you come across as just plain silly. Is this intentional? If so, you missed April Fools Day by over a month.

    Literally 90% of people who experience severe acute back pain problems at any given time feel better (not necessarily pain free) in a few months. 86% "success rate" means squat. 50% "success rate" means that you're hurting people. Do you really think anyone, let along a self-serving evangelical disc poking "healer", can turn a ruptured disc into one that looks "as if it were new" and "restore full disc height" with a blood clot? If their studies are performed with anything akin to Carragee quality, (extremely unlikely), then the data won't support the claims. He's a huckster. FDA should (and hopefully will) slam him for making clearly unproven claims on national television.

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    1. couldnt agree with you more! TSB says that they stated there are 3x as many back surg than there are hips? My ass. There are over 1.25 million hips done each and every year. And lets not forget the #1 leading reason a person misses work? It sure in the hell is'nt from their hip hurting them. Lets not forget, there is but only one way (well 2 now) to put in a hip or knee, yet there are now over 10 ways to fuse the spine.

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    2. It's from being hung over, your ass.

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    3. Trader, you are confused. Please Read the Pauza FDA Protocol. His study is excellent, because no one is allowed to enroll in the Pauza Disc biological study unless they have experienced severe, chronic low back pain lasting longer than one year, and have first tried, and failed other spine treatments. His petients have all suffered with pain for an average duration of 20 months.
      Pauza is doing good spine science. That is why he also uncovered the facts regarding IDET outcomes, in his study which was the NASS Outstanding Study.And Pauza had zero financial involvement. Naysayers abound. You do what Pauza did.

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    4. Hey 7:41pm whats up with you lame comment?

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  19. OK, so Pauza and Co. are using a commercially available biologic--aka fibrin--that's been out there for years. So why hasn't that company--either JNJ or BAX--invested in this technology since they would have seen it in the first place? Presumably they evaluated this theory / approach when it first came across their desks...

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    1. They did, but could not find a carrier that could 1, be inserted with out too much disruption and 2. Stay in the disc space for an extended period of time to work. The fibrin shot blindly into the disc would be gone in 24 hours. There needs to be a carrier. University of Michigan is also working on a "disc healer" and realize the need for a carrier. Promising stuff, but we have a ways to go.

      Sorry for any typos. IPhone typing

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  20. So again, same question: if Pauza and company are on to something that can actually "regenerate" the disc, why didn't either JNJ or BAX invest in this venture or acquire the sponsor company? With or without carrier, Fibrin alone probably doesn't "heal" the disc...

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    1. You didn't have to repeat your dumb question twice. To think JNJ or BAX are able to have the ability or are all knowing to determine blockbuster products you are quite ignorant.

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    2. We all know that whether a product is ablockbuster or not has littl to do with the science, much more to do with the how a company / reps presents and sells it. But I'd like to understand how the science is different for the various therapies (fibrin, stem cell, etc.)--not clear from the CBS piece...

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  21. Actually it's just Tisseel or fibrin glue injected into the disc space. Surgeons already do this when we try to seal in BMP to prevent radiculitis. Fibrin glue placed on the dura for dural tears causes an awful scar that is hard to dissect through when you come back in. Basically it's just making scar form inside the disc. Nothing special. Pauza misrepresents his procedure in the CBS clip (seen on Youtube). He tells the patient that he is restoring the height back to normal. He also says his procedure causes the disc to heal. Problem is 1. what happens when you inject saline into a problem disc during a discogram? Patients scream with the worse pain ever. So now you've pressurized the diseased disc trying to restore height "back to when you were a teenager" and turn it into "young healthy normal disc." So can you inject it into vertebrate fractures to restore vertebrate height and heal fractures? Not!
    2. If it's injected into diseased discs with leakage of dye, won't the fibrin glue leak out through the cracks into the epidural space? Also Why does he not use radioopaque fibrin glue in his demonstration? because you'll see the stuff leak out everywhere just like in a discogram.
    3. Fibrin glue is pretty fragile stuff, as you see when the reporter plays with it. In the OR, it's just alittle more firm than rubber cement. What happens when you stand up? the 100-200lbs of weight that then sits on the stuff will just squish it out if there are any weaknesses in the annulus.

    He presents it as some new novel idea. It's just Fibrin glue with a longer applicator gun. Why charge 5% of $100,000 or $5,000 for this device. We get it in the OR for $50. Also why do you need a trial or FDA approval for a product that is already FDA approved and that he is using off label. Where is there any real novelty or IP in this idea?

    I do have to say that in some patients with chemical radiculitis possibly with annular tears, if you can seal things up just a little to prevent leakage of disc fluid, it could help. But to present it on national TV as the next cure for 86% of all patients with disc disease is ridiculous. Just wait until lots of pain specialists start to inject fibrin glue into thousands of discs including patients with post discectomy syndrome with a large annular hole, and a large glob comes out causing cauda equina syndrome. Then it'll be the end of that idea.

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    1. Great Post. Good Stuff.

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    2. It is my understanding that an FDA approval must occur in order for any procedure or medication to become insurable. I need something insurable. Maybe Dr. Pauza's study will enable millions of people worldwide, like myself, to have affordable access to f.s. for degenerated discs, or leaky discs. Does anyone know, am I correct in my understanding that according to W.H.O. ~23% of of back pain is chronic.
      Does anyone know what percentage of chronic low backpain is attributed to DDD?

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  22. In your Thursday 10 May post you ask the question whether Science is of importance in relation to Biologics and Bone formation. While good product development, quality marketing and a suitable reimbursement environment are important for commercial success, the fundamental basis of an excellent science is the only thing that will stand the test of time and make any product a classic. Needless to say rhBMP-2 made by Wyeth and marketed by Medtronics is the clear winner not by a head or a horse length but yards, and will stay so. This molecule remains the most potent bone maker of all bone makers and of all times.

    So which molecule will make disc or be responsible for disc regeneration. As BMP was bone dervived, this putative molecule has to be a Cartilage Derived Morphogeneic Protein or a CDMP. For poetic reasons let us call it rhCDMP-2. Logically, an absence of CDMP-2 should lead to an absent disc and if this happens via a mutation then a birth defect should be seen; Like Klippel-Feil Syndrome (where kids lack segmentation of cervical vertebra or have absent discs) [Wow in fact it does PMID: 18425797]. Further logic states that in an injured disc, injecting rhCDMP-2 intradiscally should lead to healthy or new disc formation [interestingly it does PMID: 20069037]
    So, now what is required is a smart bunch of product development guys, backed by a visionary management(ie who will support a 5-6 year development plan), followed by a dynamic marketing team to bring this to market. Our politics and national debt burden (oh yes by the way, patients too) are demanding something like this. If we keep on biting at the edges in our efforts to develop biologic solution for disc degeneration, our generation will miss out on creating a classic. Someone needs to go big in this area.

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  23. By chance do any of you responders have degenerative disk disease. I do, my lady does as well as many of our friends. We all know we did not treat our bodies as we should have or had auto accidents, played sports giving us DDD in our middle years. Problem is we all learned way to late for our spine health. Fortunately not to late to guide our own children to a healthier life spine life.
    With that said those of you who may have DDD what do you think if this procedure was approved today. Would you opt for a chance to a better life? Would you do another procedure/treatment?
    Those of you who do not have DDD what are our best options 1, 2, 3 for us to discuss with her surgeon next week?. The Surgeon is talking fusion as he does not believe injections are an option. However, I will mention this procedure for his opinion.

    Until you suffer from DDD in your everyday life you will never know our urgency for a solution. So here we are waiting for FDA approval. Never thought I would say help but at a 40, 50, 86% possibility do you have a better idea and percentage of possible relief?

    If this is in a phase 3 study how much longer could it possibly be? Plus the head of the American Spine Assoc or something like that said after the segment aired he thought Dr Pauza was on the right track and felt he is diffinately on to something big with the possibility of a breakthough.


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  24. This comment has been removed by the author.

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  25. Glad to come across this post. For more information and suggestions check back pain specialist in nj. Good post.

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  26. That's the post i was looking for. This is a great explanation and a valuable information in such a perfect approach of writing?

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  27. Thank you, 'anonymous' of May 9 (11:17PM), re: Pauza's sealant basically being Tisseel.

    I was about to have Dr KP do the biostat on me, and I'd been paying out of pocket since the study is closed. But he literally REFUSED to tell me, on average, how long does his Biostat FS seem to work. I know he can't guarantee anything; I wasn't asking for that. I'm an M.D. too, and I understand trials, and what you can/can't say/promise, etc. But he seemed to cop an attitude simply because I asked 1) what complications have you noted so far? and, 2) How long does the Biostat seeme to last? Those are basic questions for which he should not have been put off.

    Either it's not lasting very long at all, or he's got some God-complex and no on can ask him anything. Without that basic info, I refused to go to TX for Rx. I'll look elsewhere. May see if anyone is using the Tisseel for intradiscal Rx. If anyone knows someone doing Tisseel for intradisc repair (or attempt to ease pain), post info, please. Thank you. Happy new year.

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    1. I met with Dr Pauza in Nov of 2013. I asked him the same question about how long the Biostat lasts. Though he was somewhat vague, he did tell me it differs from patient to patient and it depends on how you treat yourself after the procedure. He did tell me that he had patients who are still pain free after "several" years. Far short of literally refusing to tell me. If you want to see some folks posting good results, google Pauza and go to Vitals.com.

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    2. Pauza was correct as per your question regarding outcomes...this was during the FDA Study so outcomes were not available nor is it allowed to be discussed in the highest level of scientific inquiry to negate the placebo and nocebo effect. It was a safety study and an efficacy study. there were no adverse outcomes...There were no complications, and no one was made worse. Unfortunately, this cant be said for spine surgery.
      The procedure has evolved with greater efficacy since your introduction. The Pauza FDA study won the NASS Outstanding Study of the year.

      current, refined data is available for review on the science section of the link:
      www.drkevinpauza.com

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    3. Pauza was correct as per your question regarding outcomes...this was during the FDA Study so outcomes were not available nor is it allowed to be discussed in the highest level of scientific inquiry to negate the placebo and nocebo effect. It was a safety study and an efficacy study. there were no adverse outcomes...There were no complications, and no one was made worse. Unfortunately, this cant be said for spine surgery.
      The procedure has evolved with greater efficacy since your introduction. The Pauza FDA study won the NASS Outstanding Study of the year.

      current, refined data is available for review on the science section of the link:
      www.drkevinpauza.com

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  28. Spine Surgery India offers info on Spine Surgery India,Spine Surgeon,Spinal Surgery India,Back Pain,Spine Implant,Cost Spine Surgery Hospital India.If you are thinking to go INDIA for surgery, then you must search for Spine surgery India, Laser spine surgery India, Best spine surgeon India, Spine surgery best hospital India & spine surgery cost india

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  29. Several people seek chiropractic as a natural and safe method for the treatment of back pain.
    San Antonio Spine Surgeons

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  30. Arrogant Kevin Pauza Disciplined by TX Medical Board:

    Pauza, Kevin Joseph, M.D., Lic. No. J7127, Tyler

    On August 30, 2013, the Board and Kevin Joseph Pauza, M.D., entered into an Agreed Order requiring Dr. Pauza to have his practice monitored by another physician for four monitoring cycles; and within one year complete 20 hours of CME, including eight hours in opioid therapy and four hours in risk management. The Board found Dr. Pauza failed to meet the standard of care, failed to follow the Board's guidelines for the treatment of pain, failed to keep adequate medical records and failed to cooperate with Board staff.

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    1. The Board action was because the Physician, KP, stood up for the patient's rights, and did not want government accessing personal patient information without patient permission. The "Anonymous" reviewer should review the facts and compliment the Physician, KP, for representing the patient's privacy, and prevent government intrusion. "Anonymous" should review the fact that the above mentioned listing is related to the fact that KP and his staff believe a patient's medical records belong to the patient, and should not be shared without the patient permission, to the Government or other parties. That's why it involves Medical Records only, if one reads the facts. He was standing up on behalf of patients rights for privacy

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    2. The Board action was because the Physician, KP, stood up for the patient's rights, and did not want government accessing personal patient information without patient permission. The "Anonymous" reviewer should review the facts and compliment the Physician, KP, for representing the patient's privacy, and prevent government intrusion. "Anonymous" should review the fact that the above mentioned listing is related to the fact that KP and his staff believe a patient's medical records belong to the patient, and should not be shared without the patient permission, to the Government or other parties. That's why it involves Medical Records only, if one reads the facts. He was standing up on behalf of patients rights for privacy

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  31. Perhaps a similar but more evolved version of this kind of treatment is coming out of Duke University - http://www.futurity.org/gel-plumps-up-spines-shock-absorbers/comment-page-1/#comment-4631822

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  32. I had both my L3 and L4 discs injected with Fibrin Sealant by Dr. Kevin Pauza in July 2008, after having been treated even at Cleveland Clinic etc for several years with minimal success. I can tell you from personal experience that Dr. Pauza and his treatment is for real. Following several weeks of slowly ramping up my physical activity along with several months of gradual back strengthening, I was able to do more than I had previous to the treatment than I had for years. In time, I was even able to begin cutting and stacking wood for heating our house, something I wouldn't have dreamed of before. Unfortunately, I recently herniated my L4 again while improperly maneuvering a heavy box (no one's fault but my own), and I have already contacted Dr. Pauza's office to schedule another treatment. Dr. Pauza even called me to answer several questions I had. Now how many doctors take the time to do that? At age 58 with already having had back surgery plus multiple related procedures, I guess it's time for me to realize I'm not getting any younger and need to take better care of this back so I can continue to do the things I enjoy. Thank the Lord Jesus for people like Dr. Pauza who can assist with that.

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  33. There is lot of articles on the web about this. But I like yours more, although i found one that’s more descriptive.
    Pain Management Chicago il

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  34. Med Access has managed hundreds of spine surgery in India 100% success rate. The approach essentially is to work with the top most carefully selected spine surgeons who are having extensive experience and very high success rate. Also, it is always advisable to seek multiple opinions from the selected best doctors in order to arrive at the right diagnosis. It has been observed that many patients with back pain may not necessarily need intervention.
    http://medaccessindia.com/spine-surgery/
    spine surgery in India
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