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Thread: Another New Brace

  1. #1
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    Another New Brace

    Never argue with an idiot. They always drag you down to their level, and then they beat you with experience. --Twain
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    Surgery 2/10/93 A/P fusion T4-L3
    Surgery 1/20/11 A/P fusion L2-sacrum w/pelvic fixation

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    Nonsense

    I was discussing this article in a PM recently.

    Upon re-reading it, I conclude it can not have been peer reviewed and not just because of technical matters like misspellings and inadequate (read absent) explanations of tables and graphs but for dishonest presentation of what is and isn't known in this field and comparing apples and oranges. It's a train wreck all by itself and is so bad it brings the already train wreck of the bracing literature even further down.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
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    "We are all African."

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    Quote Originally Posted by Pooka1 View Post
    I was discussing this article in a PM recently.

    Upon re-reading it, I conclude it can not have been peer reviewed and not just because of technical matters like misspellings and inadequate (read absent) explanations of tables and graphs but for dishonest presentation of what is and isn't known in this field and comparing apples and oranges. It's a train wreck all by itself and is so bad it brings the already train wreck of the bracing literature even further down.
    Not on the brace topic, but I read a "peer reviewed" article on another topic which was full of grammatical errors, commas instead of periods, etc. I was totally shocked. Not that the information was necessarily bad, but the embarrassment for the writers and how did it get passed with all that. So now I will read about the brace.

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    Probably my own ignorance

    Okay, I have read the article, which is published. It was always my belief that a published article in a credible medical journal had to be peer reviewed. Is this a misconception? This article had the same types of "mistakes" that the other article had, not meaning that the information is bad. I am not a Ph.D., so I don't really have the right to critique an article as though I were a "peer". However, as a layperson, obvious mistakes seem to take the credibility away from the message being presented, no matter what message that may be. With that said, perhaps the other article that I mentioned was not peer reviewed.

    With that said, I think this type of bracing may hold some promise. In my untrainedness, I have a few questions/concerns about this brace. At first, I was impressed that they were even taking into consideration the transverse plane in a figure showing the construct of a brace for this disease, which is seldom, if ever, even mentioned. My major question would be the derotation aspect of this brace. It doesn't make sense to me to allow for free movement with the concavity of a curve to correct a rotation. If one looks at most radiographs of the scoliotic spine, at least in what I have observed, the spinous process "tries" to stay straight even when the vertebral body is rotating. Now if you take a bend and allow farther bending in the same direction, it only makes sense from a physics perspective that the rotation would increase. This would be a very bad thing in the transverse plane.

    The next, very BIG, problem that I see is the intentional removal of natural lordosis in the lower spine. Yes, these sample radiographic outcomes "look good" in the coronal plane, but there is not one radiograph of a single subject in the saggital plane. Lack of lumbar lordosis, as far as I know, causes a great deal of back pain later on in life. This subject was never even mentioned other than to say they removed the lordosis to achieve a correction in the coronal plane. It looks good in pictures, but I would have liked to have seen the saggital views. These subjects may very well avoid surgery for scoliosis per se, but end up later in life having surgery for flatback or DDD due to the uneven pressure exerted on the discs from lack of lordosis. Although I DO know that for thoracic curves, the same technique is applied with regard to sacrificing the natural kyphosis, in effect creating a hypokyphotic situation in order to achieve a coronal correction. As a person living with severe hypokyphosis, I can tell you that there are definite problems when the hypokyphosis is too great, such as sever neck strain and limited neck mobility. However, I'm not sure how much kyphosis is lost with these other braces, or if the long term outcome is as severe as loss of lumbar lordosis. We don't have to be doctors to know that low back pain in adults without scoliosis is FAR more common than complaints of upper back pain.

    Another, lesser concern that I see is in the one figure they actually show an overcorrection. I don't know if this would be an actual concern or not, as I have no knowledge of the impact this has later on. When there is a problem with curvature and you kick it too far in the opposite direction, will the curve continue in that opposite direction? I have no clue here. But this overcorrection wasn't even mentioned. Granted, the curves were small enough to be considered nonscoliotic. It just makes me think. I guess what bothers me most about this is, let's say we have a stack of kids blocks and are able to stack them with the curvature and rotation that was in this spine without them falling. All of the blocks in the curve would have a rotation toward the convexity of the curve. Now when this curve gets overcorrected, do the blocks still all rotate toward the direction of the new convexity, OR do they sit askew on top of one another? The reason I'm thinking this is because of the fact that there is a natural force that holds a scoliosis in place. When an overcorrection occurs, would some of these vertebrae still tend to be pulled by that original force? This is a more general curiosity that could be asked of ANY bracing method and would not be unique to this one. That's why I said it is a lesser concern.

    With that said, I will repeat what I said at the outset. From the two sets of radiographs that they used in their figures, it looks like it could be promising. But like any layperson, I can't say for sure. That's just my take on the whole thing. As a parent would I try it? Probably.
    Last edited by rohrer01; 03-10-2012 at 11:07 AM. Reason: I should proofread before submitting a post!

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    Quote Originally Posted by Pooka1 View Post
    I was discussing this article in a PM recently.

    Upon re-reading it, I conclude it can not have been peer reviewed and not just because of technical matters like misspellings and inadequate (read absent) explanations of tables and graphs but for dishonest presentation of what is and isn't known in this field and comparing apples and oranges. It's a train wreck all by itself and is so bad it brings the already train wreck of the bracing literature even further down.
    Could you be more specific, as I was. This will help me understand where you are coming from. I understand the mistakes in the article, but I'm a little confused by your statement as to apples and oranges. What part is nonsense, aside from the grammatical and figures? Thanks.

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    Spine pub by same group reporting on lumbar curves

    Here's the same group reporting on lumbar curves with the new brace

    Treatment of Lumbar Curves in Scoliotic Adolescent Females With Progressive Action Short Brace (PASB): A Case Series Based on the SRS Committee Criteria

    Aulisa, Angelo G; Guzzanti, Vincenzo; Perisano, Carlo; Marzetti, Emanuele; Falciglia, Francesco; Aulisa, Lorenzo

    Spine., POST ACCEPTANCE, 25 January 2012


    Study Design. Prospective interventional study.

    Objective. To determine the outcomes of adolescents affected by idiopathic lumbar scoliosis treated Progressive Action Short Brace (PASB).

    Summary of Background Data. The efficacy of conservative treatment of scoliosis is still debated. In a recent study, we showed that Progressive Action Short Brace (PASB) was effective in correcting deformities in adolescents with idiopathic thoracolumbar scoliosis. The purpose of the present study was to extend our preliminary findings by determining the results of PASB bracing in scoliotic adolescents with lumbar curves.

    Methods. Patients were 40 adolescent females (mean age: 11.6 +/- 0.7 years) with lumbar curves and a pretreatment Risser score between 0 and 2. All patients were prescribed with full-time PASB. The minimum duration of follow-up was 24 months (mean: 41.6 +/- 34.5 months). Antero-posterior radiographs were used to estimate the curve magnitude (CM) and the torsion of the apical vertebra (TA) at 5 time points: beginning of treatment (t1), one year after the beginning of treatment (t2), intermediate time between t1 and t4 (t3), end of weaning (t4), 2-year minimum follow-up from t4 (t5). Three outcomes were distinguished: curve correction, curve stabilization and curve progression.

    Results. A significant reduction in CM was achieved from t1 (26.4[degrees] Cobb +/- 2.8 SD) to t5 (13.8[degrees] Cobb +/- 7.9 SD; p < 0.001). Likewise, PASB reduced TA from 10.8[degrees] Perdriolle (+/- 3.7 SD) at t1 to 7.9[degrees] Perdriolle (+/- 4.2) at t5 (p < 0.05). Curve correction was accomplished in 82.5% of patients, whereas a curve stabilization was obtained in 17.5% of patients. None of the patients experienced a curve progression.

    Conclusion. The PASB allows to reach a complete curve correction in most cases. No patients exhibited a curve progression.

    (C) 2012 Lippincott Williams & Wilkins, Inc.
    They are dealing with smallish L curves which are the least progressive of curve types last I recall.

    No control group... for small L curves that should make this study unpublishable.

    One thing is hopefully for sure... Spine will have reviewed the paper and there will be no typos, unexplained graphs and tables, etc. If there are then I will change my opinion about the quality of Spine.
    Last edited by Pooka1; 03-10-2012 at 03:19 PM.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
    Answer: Medicine


    "We are all African."

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    Quote Originally Posted by rohrer01 View Post
    Could you be more specific, as I was. This will help me understand where you are coming from. I understand the mistakes in the article, but I'm a little confused by your statement as to apples and oranges. What part is nonsense, aside from the grammatical and figures? Thanks.
    The apples-oranges is comparing their data on TL curves to data that is (presumably largely) T curves. Dishonest.

    The other problems are what I bang on about all the time in addition to some data selection and not considering intent to treat.

    All intermediate time points are IN BRACE. Why is this publishable??? These kids wore the brace for about 5 years. I want to see them break out the data by individual case. They didn't have all that many so they could have done that.

    I would have to go back and read it again to make more specific comments which I am very sure I could.
    Last edited by Pooka1; 03-10-2012 at 03:13 PM.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
    Answer: Medicine


    "We are all African."

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    From the TL paper...

    Measurements were independently obtained by two observers. The end-vertebrae were preselected to reduce inter-observer error [25].
    This might also have the effect of forcing a decrease in the measurement by the end of the bracing. Why didn't they just let the observers decide the end vertebra for themselves and then see if they differed in choice? With the PIs telling them where to measure it doesn't seem honest. We know from the Hawes case that selection of end vertebra can have a huge effect.

    I am skipping through the paper and will go through much more closely of folks want to do the same and discuss it. Now I am off to do some hill work with my boy horse. :-)
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
    Answer: Medicine


    "We are all African."

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    I used to think that end points should be consisten with each radiograph. I now know better, as curves change, so do endpoints. I think the endpoints measured by several physicians of the same radiograph should be the same. I don't see anything unethical about choosing an appropriate endpoint and sticking to it for the same radiograph. But you can't keep using that same endpoint throughout the follow ups because, like I said, they change.

    I wondered about that one figure. I saw all the little plastic dots and figured it was with the brace on. I was primarily interested in the end result.

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    Quote Originally Posted by rohrer01 View Post
    From the two sets of radiographs that they used in their figures, it looks like it could be promising.
    Data selection.

    We actually have available to us an "acid test" as to whether a majority of experts think a brace has been shown to work... see whether BrAIST has been immediately halted on ethical grounds based on the results (if they are still enrolling). If BrAIST continues then any new journal article has not persuaded the majority of surgeons.

    Remember BrAIST is dozens of experienced pediatric orthopedic surgeons with a combined experience base well into the hundreds of years at 26 (or possibly more by now.. they keep joining) medical centers who all agree that randomizing a kid to a no-brace group is ethical given the piss poor state of the bracing literature.

    When that group moves in response to a journal article then I'll care. Not before.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
    Answer: Medicine


    "We are all African."

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    I don't know if it's right, but the big multi-center studies use the same upper and lower end vertebrae to measure curves before and after surgery.
    Never argue with an idiot. They always drag you down to their level, and then they beat you with experience. --Twain
    ---------------------------------------------------------------------------------------------------------------------------------------------------
    Surgery 2/10/93 A/P fusion T4-L3
    Surgery 1/20/11 A/P fusion L2-sacrum w/pelvic fixation

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    Quote Originally Posted by Pooka1 View Post
    Data selection.
    In cell biology, where data sets are completely based on mathematics (because we have to count cells) sometimes unethical people with throw out a few outliers in their curves to make them look, well, more perfect. We call that "massaging the figures".

    Linda,
    I can't think that always choosing the SAME end vertebrae can be in any way accurate. If the correct Cobb method is to choose the most tilted end vertebrae, then it could and should change with every radiograph if there is any kind of progression at all.

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    Quote Originally Posted by LindaRacine View Post
    I don't know if it's right, but the big multi-center studies use the same upper and lower end vertebrae to measure curves before and after surgery.
    Surgery has different goals in some sense than bracing and PT. Unlike bracing and PT, we know surgery will reduce a curve so accurately measuring the before and after Cobb is not really an issue. All curves except those that have to be fused in place are reduced, many dramatically. It doesn't matter if the curve is reduce 50% or 75% or 90%, all else equal. It is proven for surgery but not for conservative modalities so they need to prove themselves and do it honestly.

    The jury is NOT out on the ability of surgery to reduce curves for life. It can.

    The jury is NOT out on the ability of bracing to reduce curves. It can't long term.

    The jury IS out on the ability of PT to reduce curves long term though there is anecdotal evidence but few will keep that protocol.

    The jury IS out on the ability of bracing and PT to hold curves for life.

    All of that is w.r.t. straight AIS and may not apply to Marfans, Chiari/SM, CMT, etc. etc. etc.

    ETA: So since curve reduction is a given with surgery and amount isn't critical to success (within bounds), I think the reason they use same end vertebra in surgical research is because they have to have some baseline or constant in order to study how to select the best end vertebra. That is very different than for bracing and PT which are trying to make claims about stabilization and reduction and aren't potentially going to do anything different if end vertebra of the curve change in the treatment. Their claims are that the curves stabilize or reduce FULL STOP and so should be using the straight Cobb method. If selecting the same vertebra results in a reduction and selecting the correct vertebra doesn't then how honest is it for a brace study to pre-select vertebra?
    Last edited by Pooka1; 03-12-2012 at 06:30 AM.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
    Answer: Medicine


    "We are all African."

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    For fused portions of the spine, measuring the curve is simply a matter of knowing what kind of correction was received, in MY opinion. However, in the non-fused areas of the spine, there is still room to wiggle and that should be kept an eye on. Yes, you are correct that many non-fused curves decrease after fusion of the structural curve. But, things CAN and DO progress in unfused areas for some people. Think of those who develop junctional kyphosis. Granted, this is a forward bending, but to say a lateral bending can't occur would be ridiculous if there is flexibility in that portion of the spine. To say that all fused spines do not progress is also not correct. I know someone personally who had a very severe curve fixed with nasty Harrington rods. Her curve, though fused, has progressed again over time...why? Did she not fuse properly the first time? As far as I know, there was fusion and there and no broken rods. I suppose I could interview her next time I see her, as I could be wrong, but this was how I understood her story.

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    Quote Originally Posted by rohrer01 View Post
    For fused portions of the spine, measuring the curve is simply a matter of knowing what kind of correction was received, in MY opinion.
    Not sure what your point is here.

    However, in the non-fused areas of the spine, there is still room to wiggle and that should be kept an eye on.
    Yes absolutely but I am talking about assessing the claims that braces and PT hold or reduce (primary) curves. Talking about that is not to say there aren't other issues.

    Yes, you are correct that many non-fused curves decrease after fusion of the structural curve. But, things CAN and DO progress in unfused areas for some people.
    As they can do in untreated curves (see collapsed spine cases I posted where some folks now need fusion to the pelvis when they wouldn't otherwise need that).

    It is not an open question whether surgery reduces curves, in most cases for at least decades.

    It IS an open question whether bracing or PT reduces or stabilizes curves for at least decades. Even for the folks who don't progress, it is impossible to show the treatment was needed in the first place. Recall we have at least a few cases where curves made it to the 50* range and hung there all by themselves, in one case for about two decades.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
    Answer: Medicine


    "We are all African."

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