Clear data pub count down

[Pooka1]

Josh Woggon (chiro) wrote on 11 Jan 2010:


Rest assured, the CLEAR Scoliosis Treatment Advancement & Research (STAR) Clinic in Dallas, Texas, will be publishing case studies including functional outcome assessment measures such as chest expansion values & lung capacity in the near future, to satisfy those individuals (like myself) who prefer hard data. :-)

I'll be posting to this thread over time if any relevant data comes out or if it doesn't in the "near future."

[Pooka1]

Are there any peer-reviewed Clear papers? I can't find any.

Here's an unpublished study frm Clear...

http://www.clear-institute.org/Portals/0/docs/ScoliosisCorrection.pdf

I'd like to ask if I'm the only one who sees the Cobb angle lines on the two sets of radiographs as having been deliberately misdrawn to increase the pretreatment measurement and decrease the post-treatment measurement. In one case, the line is obviously not drawn parallel to the edge of the vertebrae. Those curves don't appear to have changed much if at all.

And it completely creeps me out that chiros deal with radiation and measure Cobb angles. How is that legal? Do they have the rad safety training and why isn't that practicing medicine?

[tonibunny]

One does wonder why they have not used the same vertebrae in the before and after x-rays! You'd think it would be a fundamental factor in measuring and comparing curves. I think it would be very interesting to have a qualified MD measure them; to my untrained eye, the line drawn on the bottom of the "before" x-ray looks wrong somehow.

[skevimc]

To give them the benefit of the doubt, x-rays don't translate well to a paper picture. So it's possible that we aren't seeing the landmarks they used. Certainly not defending it because I definitely see what you mean.

From a clinical point of view, measuring the angle as it is on the film is important. Rather than using the same vertebral landmarks. Curves change shape so it's important to treat the curve.

From a research point of view an argument can be made for both. Using the same vertebrae is good for consistency but not as good if the curve changes shape too much. Measuring the curve like you would clinically will mean more to clinicians than if you keep the same vertebrae.

My issue is when things claim to be 100% effective. The article they reference (Morningstar 2004) has a 100% effective rate on his cohort. I'm not suggesting they are lying. But wonder what data they have of people not responding to this type of therapy.

[Pooka1]

I don't know about the choice of vertebrae question but even with the poor quality of the pictures, you can clearly see at least one line is not draw parallel to the edge of the vertebra.

If you scan those curves they appear to be almost identical.

It is excrable how misleading this is.

[jrnyc]

aw, shucks..read the name of the thread & thought those clear guys were meeting at a pub to take the scoli cure...the "if i drink a few i will still have scoli, but i wont care"

oh well...the search for an alternate cure continues...:)

[LindaRacine]

And it completely creeps me out that chiros deal with radiation and measure Cobb angles. How is that legal? Do they have the rad safety training and why isn't that practicing medicine?

No kidding! Where are the shields?

The paper is just laughable.

[hope404]

I'm not sure why this paper was printed(was it for some kind of intro class)...it seems to be a very "beginner" "intro" type article

I have seen other CLEAR articles that are very professional... indepth and excellent.

[Pooka1]

aw, shucks..read the name of the thread & thought those clear guys were meeting at a pub to take the scoli cure...the "if i drink a few i will still have scoli, but i wont care"

oh well...the search for an alternate cure continues...:)

LOL!

These Clear guys remind me of the homeopathy guys on this video...

http://www.youtube.com/watch?v=HMGIbOGu8q0

[Pooka1]

My issue is when things claim to be 100% effective. The article they reference (Morningstar 2004) has a 100% effective rate on his cohort. I'm not suggesting they are lying. But wonder what data they have of people not responding to this type of therapy.

Here is that paper...

http://www.biomedcentral.com/content/pdf/1471-2474-5-32.pdf

Some obvious questions present...

1. 22 non-randomized patients. Is that another way of saying these were the only 22 who responded? They are going to need to show that this isn't an extreme case of data selection as it certainly appears to be. They also have to show that they understand why data selection is a bad thing. I challenge them to explain ALL the reasons why these particular 22 patients were selected and ALL the reasons why other patients were excluded. If only 22 out of 500 had a reduction, it would be highly misleading to publish this paper.

2. This study is now several years old. I challenge the authors to publish or post what happened in the ensuing years for as many of these patients as possible. I don't understand why a 4-6 WEEK PT study is publishable; Nobody doubts the ability of some PT to reduce some curves in the very short term, do they? The real question is whether these curve reductions held after treatment ended... unlike some other PT modalities, I think Clear claims you can end treatment at some point but I need to confirm that.

I once read an article review written by Morningstar and was very impressed with his knowledge and reasoning ability. That would be in keeping with his association with evidence-based chiro. I just would really like to see his responses to my challenges.

[hdugger]

OK, I'm just scanning the report, but I see 4 data points (at least 35 degree curve in an adult spine with at least a 10 degree reduction).

Patient data is:

(columns: gender/age, initial measure, final measure, reduction)

1 F/19 32 24 8
2 M/17 23 8 15
3 F/15 29 11 18
4 F/64 52 19 33
5 F/16 19 4 15
6 F/22 28 11 17
7 F/27 16 2 14
8 F/34 25 11 14
9 F/21 35 20 15
10 F/41 28 13 15
11 F/53 40 22 18
12 F/18 31 9 22
13 F/16 27 14 13
14 F/20 33 7 26
15 F/23 32 18 14
16 F/15 16 4 12
17 M/33 15 4 11
18 M/24 21 6 15
19 F/25 38 11 17

The 52 to 19 degree reduction in a 64 year old is particularly striking.

I would also like the know the success rate for this particular regime, but it does add to the idea that exercise can reduce curves. I'm assuming the exercise has to be continued to hold the reduction.

Pooka, he kind of addresses your questions - "Although we attempted to select patient files at random from 3 separate spine clinics, nonrandomized sample populations such as ours do not necessarily reflect the potential outcomes in a general population. Therefore, future studies in this area should incorporate a control group and a randomized patient population. Followup studies should also focus on the potential long-term benefits of conservative scoliosis treatment, given the relative scarcity of biomedical literature available on longterm benefits from any scoliosis treatment."

My issue with their results (and, again, I'm only skimming) is that based on reports I've heard here, the regime is very hard to maintain and requires lots of time and specialized equipment. If, as I assume, the regime has to be maintained to maintain the curve, it's not simple enough for a life-long treatment. I'll try to read in more detail later, to verify.

[Pooka1]

Pooka, he kind of addresses your questions - "Although we attempted to select patient files at random from 3 separate spine clinics, nonrandomized sample populations such as ours do not necessarily reflect the potential outcomes in a general population.

Attempted to select randomized patient files? What prevented them from doing so? Poor results?

[skevimc]

Some obvious questions present...

1. 22 non-randomized patients. Is that another way of saying these were the only 22 who responded? They are going to need to show that this isn't an extreme case of data selection as it certainly appears to be. They also have to show that they understand why data selection is a bad thing. I challenge them to explain ALL the reasons why these particular 22 patients were selected and ALL the reasons why other patients were excluded. If only 22 out of 500 had a reduction, it would be highly misleading to publish this paper.


It's more likely a convenience sampling. That is, they looked through their charts and identified patients with scoliosis, then approached them to participate in the study. They may have also excluded, or not approached, any patients that were already in a brace. :confused:



2. This study is now several years old. I challenge the authors to publish or post what happened in the ensuing years for as many of these patients as possible. I don't understand why a 4-6 WEEK PT study is publishable; Nobody doubts the ability of some PT to reduce some curves in the very short term, do they? The real question is whether these curve reductions held after treatment ended... unlike some other PT modalities, I think Clear claims you can end treatment at some point but I need to confirm that.


That is definitely the real question, will it last. This was my biggest gripe with Mooney's work. His second paper used the entire population of his first paper but he added a few additional patients. They were published several years apart. He could have published a follow up along with the new patients. Instead the two papers made it seem like they are two separate groups. Same with the Morningstar paper. Publish a follow up.

And before anyone says "yeah but you did a study also". I include our study in this critique. A follow-up should be posted. For our study...There might be some HIPPA concerns with me looking at data when I'm not at KU anymore. IRB's (internal review board) also can be tricky because we didn't ask the patients if we could contact them years later. Plus, in order to make the paper worth anything, I'd want to include strength data and other measurements. I'm contemplating contacting Dr. Asher to see about this possibility.



I once read an article review written by Morningstar and was very impressed with his knowledge and reasoning ability. That would be in keeping with his association with evidence-based chiro. I just would really like to see his responses to my challenges.

I think I read the same article and was also impressed. He seemed to have a different way of thinking than what I believed about Chiro's. As well, in the above paper the discussion section is pretty good. I really think that the treatment has sound physiology behind it. I am just opposed to 'adjustments'. He states that not everybody needs them. But still says that "treatment should include both manipulative and rehabilitive procedures."

I am not current in the Chiro literature but the discussions I've had with other clinicians is that nobody knows exactly what 'adjustments' are doing other than releasing joint gas and a surge of epinephrine which accounts for the temporary pain relief. As well, what imaging studies are there to show that an 'adjustment' even happens? That is, you pop a vertebrae, does it just stay in the same place or have you actually moved it? If anybody has more information I'd be glad to look at it.

[Pooka1]

(snip)
That is definitely the real question, will it last. This was my biggest gripe with Mooney's work. His second paper used the entire population of his first paper but he added a few additional patients. They were published several years apart. He could have published a follow up along with the new patients. Instead the two papers made it seem like they are two separate groups.

Wait a minute. The two patient populations for the two Mooney papers overlapped extensively? Are you saying he asked these patients to participate in two studies or are you saying he republished already published data?

If the former, is there some way to recover the curve trajectories of the overlap patients between the two studies?

If the latter, I think we simply at this point have to have some respect for the dead. If he was still alive, of course that would be (or should be) actionable. Did the peer reviewers know this in real time?

As I understand it, Mooney was an orthopedic surgeon of good repute and wide, long experience. I wonder if he was simply getting to the end of his life and and was throwing a Hail Mary in the form of torso rotation.

Of a Morningstar pub...


I think I read the same article and was also impressed. He seemed to have a different way of thinking than what I believed about Chiro's. As well, in the above paper the discussion section is pretty good. I really think that the treatment has sound physiology behind it. I am just opposed to 'adjustments'. He states that not everybody needs them. But still says that "treatment should include both manipulative and rehabilitive procedures."

Actually I was referring to a critique/review of another published article though I agree the 2004 article is well written also. In the critique, his points were well taken, logical, and intellectually honest. It was at that point that I thought evidence-based chiro was the only hope to save chiro if they have others like him.


I am not current in the Chiro literature but the discussions I've had with other clinicians is that nobody knows exactly what 'adjustments' are doing other than releasing joint gas and a surge of epinephrine which accounts for the temporary pain relief. As well, what imaging studies are there to show that an 'adjustment' even happens? That is, you pop a vertebrae, does it just stay in the same place or have you actually moved it? If anybody has more information I'd be glad to look at it.

Over on Quackwatch, there is an article on how no two chiros can point to the same spot on a radiograph as to where the subluxation is located. That tells me it is imaginary. Anything REAL within chiro will be within the field of medicine, not outside of it.

Last, I have had chiro adjustments on my horse. He went from an extreme pain reaction along his back to no pain when doing the identical touch to elicit a pain response. Clearly a nerve was unblocked or some chemical was released as you suggest. But whatever it was it was real and therefore within the field of veterinary medicine... horses can't be talked out of pain. :)

[Pooka1]

Answering my own question here...

Yes in fact he simply republished the original data set of 12 patients (Mooney et al., 2000) in Mooney and Brigham (2003). It's not even that he picked up with them and enrolled them in the new study... he simply reused the identical data.

Among the original patients, five had measurable reductions out of 12 (= 42% "success").

Among the eight new patients included in the 2003 paper, only two had a measurable curve reduction (10* -> 4* and 34* -> 25*). That is 25% "success." It seems inclusion of kids with lumbar curves brought the "success" rate down... those seem to not respond much if at all to torso rotation.

Taking all 20 patients together, the "success" rate was 35%.

Twenty patients total.

[skevimc]

Taking all 20 patients together, the "success" rate was 35%.




I would change this by saying that I think most studies are focused on trying to stop progression and not necessarily trying to reduce the curve. That is what we were doing. It's sort of coming at it from the other direction, i.e. how many failures were there? Failure generally defined as two consecutive x-rays >5° from baseline.

[Pooka1]

I would change this by saying that I think most studies are focused on trying to stop progression and not necessarily trying to reduce the curve. That is what we were doing. It's sort of coming at it from the other direction, i.e. how many failures were there? Failure generally defined as two consecutive x-rays >5° from baseline.

That is a very good point.

But I think unless you can show these kids would have progressed anyway during that treatment period, you can't assume the ones that didn't advance >5* were helped by the treatment. For example, my one kid held in the mid 30s* for at least 6 months before she started wearing her brace. Had she been enrolled in Mooney's study during this six-month period she would have been counted in the "success" column for the treatment. And yet back in reality she didn't do a lick of exercise, targeted or otherwise, to achieve the stabilization.

That's why I find myself persuaded by the Hdugger Paradigm (TM) :) of looking at reductions and mainly in larger curves in order to have any confidence that the treatment is actually influencing the observed results. And then of course the issue fo long term and permanence has to be tackled.

This strikes me as a particularly difficult field of research... even including a group of 20 controls who are sitting there just watching the other 20 do the PT (:)), that is still not enough to know what is going on when the condition is so variable... curves stop and start on their own, curves spontaneously reduce and even disappear, some large curves get to 50* and hang there for decades, etc. etc. etc.

[hdugger]

I think it's impossible to know the success rate (rate of halting progression and/or avoiding surgery) in any of these studies. I'm using the reduction rate as a rough measure of relative success. So, a method that produces lots of reductions is likely more successful in holding a curve than one that produces only a few (in people of similar ages, curves, etc.)

Kevin, do you have a sense why orthopedic surgeons aren't more interested in exercise? I realize that bracing appears more effective in holding curves during rapid progression, but exercise shows some promise in keeping small curves small. I'm just surprised that it's not a hotter field of study.

[Pooka1]

Kevin, do you have a sense why orthopedic surgeons aren't more interested in exercise? I realize that bracing appears more effective in holding curves during rapid progression, but exercise shows some promise in keeping small curves small. I'm just surprised that it's not a hotter field of study.

I will look forward to Kevin's answer for sure.

I think to show PT is effective in keeping small curves small, you would need an impossibly huge study group. First, this group of small curves has a fairly high rate of spontaneous decrease and even complete resolution. Second, even when adding in moderate curves, ~90% of curves are not going to be surgical. So what a study would need to show is that the ~90% is raised to something like 95% or better avoiding surgery in order to show an effect from PT as far as I can tell. And that is a tall order.

[skevimc]

Kevin, do you have a sense why orthopedic surgeons aren't more interested in exercise? I realize that bracing appears more effective in holding curves during rapid progression, but exercise shows some promise in keeping small curves small. I'm just surprised that it's not a hotter field of study.

Certainly an argument can be made that there are no RCT's looking at a specific exercise therapy. But I think the number 1 reason surgeons aren't interested is 'clinical dogma'. Look at any national organization or information website on scoliosis. The ones that even mention 'exercise' all say the same basic thing "exercise can help muscle tone but can't affect the curve" or it is thrown in with chiropractors (which are not respected by MD's anyway) in the "alternative therapies" classification. Even the Scoliosis Research Society only mentions Observation, Bracing, surgery under "what are my treatment options.

There are 4 papers that started this trend. Shands 1941; Stone 1979; Casella and Hall 1991. And when added to brace Carman 1985. IMO, these four papers have set in stone that exercises are only useful for posture, maybe pain management and general heath.

SOSORT and IRSSD certainly are interested in exercise. But active surgeons don't have time to go to these smaller conferences which is of course where most of the data in favor of exercise is presented and debated. Therefore, most practicing docs don't know about what's being discussed. Or, if they do then it's on a very superficial level.

To grab the attention of surgeons you have to publish in Spine. You won't publish in Spine until you have at least 100 patients (plus 50-100 controls) with a high risk for progression and about 4 years of follow up data to prove that it is effective and long term. But you won't do all of the above until you have three or four busy clinics that are willing to send you the next 100 patients through the door. And you won't get that until...... I think you get my point.

Short term, messy studies that make huge overstatements do little else but detract from real evidence. (Starting a commercial venture doesn't help either). It's why we tried to add as much patient information in our tables and did a survivorship analysis and concentrated on a critical discussion of our results. We wanted to show that while our numbers were low, we made a serious scientific effort. This would also allow us to have faith in our own findings. A few other studies have done this as well (for example, den Boer "Side Shift Therapy"). But until these types of studies are the norm OR you get a huge data set (and preferably both) exercise therapies will most likely remain an "alternative therapy"

Sorry for the long post. As a rehab scientist, exercise therapies are routinely placed at the "kid's table", so it's a hot button for me. I could go on and on about this. The introduction of my dissertaion included a brief history of scoliosis management. I found references back into the mid 1800's. One common theme... Brace versus exercise. :rolleyes:

[hdugger]

Not overly long at all. That was very helpful. I had a similar discussion with my masseuse (who did a great deal to improve my son's appearance and, we think, to slightly reduce his main curve) and she said something similar about why massage wasn't an approved therapy. You have to show that it works in the scientific papers, and individual practioners just don't have the number of clients where they could show results, because they aren't sent enough clients because they don't publish, and so on and so on. It is all very frustrating.

But, physical therapy *has* broken through for resolving other back problems, and now is routinely mentioned as a better solution than back surgery. (I understand that it's also more effective for other back problems). But, I wonder if the turning point for scoliosis will be the point at which some set of practices is:

* freely shared and available to physical therapists
* regularly showing reductions in significant curves (again, because it's so much easier to publish these studies)
* showing long term results

I realize that exercise is not going to be *the* solution, but I would like to see it developed as a viable treatment for some subset of scoliosis patients. And I'd absolutely like to see it vetted enough that it is routinely offered to children with small curves during the "watch and wait" period, and to adolescents who reach maturity without requiring surgery.

Do you have a sense whether there's a subset of the scoliosis population for which exercise is less effective? I realize you probably don't have a lot of data points in any category, but we've talked here about whether exercise might be less effective for congenital scoliosis and/or for patients with connective tissue disorders.

[Pooka1]

I would change this by saying that I think most studies are focused on trying to stop progression and not necessarily trying to reduce the curve.

By the way, why is that?

It seems highly likely the reductions in the larger curves were due to the PT (though that can't be shown rigorously).

Has the PT community collectively ruled out curve reduction as a goal for some reason?

[skevimc]

But, physical therapy *has* broken through for resolving other back problems, and now is routinely mentioned as a better solution than back surgery.


I thought of this last night as well. PT has broken through and is the first choice by doctors for low back pain.

We also needs to present at PT conferences instead of surgeon conferences. PT need to get excited about this and we're un-intentionally keeping it from them.



And I'd absolutely like to see it vetted enough that it is routinely offered to children with small curves during the "watch and wait" period, and to adolescents who reach maturity without requiring surgery.


DING DING DING. We have a winner!! This has become my main argument. Give me (research) all of your patients during the watch and wait period. If after 4-6 months there is progression, carry on with bracing. Nothing ventured nothing gained. But if they don't progress, let me (research) have another 4-6 months. I'll 'buy' my way to skeletal maturity 4-6 months at a time.

Some will say, "but the curves are so small you don't know which ones will progress". That's true, but I'll put my protocol on 100 patients and do a retrospective study on 100 watch and wait patients and I bet I'll have fewer that progress to a brace. Then let's do another 100 patients. And another. In two or three years you could have a couple of hundred patients. If a practice wanted to, this study could be done relatively cheaply.

I've seen it mentioned here before and believe it to my core, we are missing a huge window of opportunity in curves <25*.



Do you have a sense whether there's a subset of the scoliosis population for which exercise is less effective?

Aside from patients with contraindications, the only thing I can say about that is high thoracic curves might not benefit unless there are some very specific exercises. Also, lumbar curves seem to be somewhat resistant. I have no real evidence for any of this though.



By the way, why is that?

Has the PT community collectively ruled out curve reduction as a goal for some reason?

I think because that's the primary goal of bracing as well. And since we are attempting to have an alternative to bracing we use their guidelines.

Plus, in the beginning, it's always best to set the bar low. With no real science to suggest that the curve is reducible with strength training, we're just trying to stop progression. If you recruit a patient saying that therapy will reduce the curve instead of just stopping it then people get upset if that doesn't happen. So you say that we're trying to stop progression and if it reduces it, then that's a bonus.

[hdugger]

We also needs to present at PT conferences instead of surgeon conferences. PT need to get excited about this and we're un-intentionally keeping it from them.

Yes, exactly. We did actually get a prescription from our orthopedic surgeon for physical therapy during the watch and wait period. But, our physical therapist, while good, did not have enough good information about how to approach a scoliosis patient. If he'd been exposed to some of the studies coming out about scoliosis exercise, my son might now still have a 35 degree curve instead of a 57 degree one.

Also, there is a tendency for surgeons to compare their work to "physical therapy" (general case rather than a specific methodology). As long as physical therapists are taking a hit and miss approach, they're always going to come out poorly in this comparison. If, instead, there were a generally agreed upon methodology for dealing with scoliosis, I think these comparisons would be more favorable.



Aside from patients with contraindications, the only thing I can say about that is high thoracic curves might not benefit unless there are some very specific exercises. Also, lumbar curves seem to be somewhat resistant. I have no real evidence for any of this though.


[hdugger's ear perk up] Having a son with a high thoracic curve (T2 - T7) I'd be interested in hearing more about the specific exercises for those curves. Our completely unscientific experience has been that two things have made a difference in his curve. One is that his masseuse gave him stretches for reducing his "head forward" posture so that his ear is now 2 inches in front of his shoulder (down from 4 inches in front). The second is that she did some work to drop his shoulder blade down and to the left. He also does two stretches which involve that area. The rest of his PT work is basic core exercise. Has anything else shown promise for high thoracic curves?

[skevimc]

[hdugger's ear perk up] Having a son with a high thoracic curve (T2 - T7) I'd be interested in hearing more about the specific exercises for those curves.



Sorry.:o I should say "undiscovered specific exercises". It was somewhat clear when watching some of the girls with HT curves do the rotation exercises that the movement occurs lower. So it is questionable how much activity the upper thoracic spine is getting. I spoke with a back therapist who attended a seminar I gave back in KC and he was really interested in the protocol. We spoke specifically about curves in different locations. He thought that arm positioning, during rotations, could help target these hard to reach muscles. For example, bringing the arms up to parallel with the floor or higher might activate the upper musculature more. I don't know.. Time to buy a fine wire EMG unit and talk some parents in to letting me stick a bunch of needles in their child's neck and back while they work out.

There's one girl I think of who had a HT curve. She did the strengthening and a few other things (her parents were using the kitchen sink approach). But they did some rolfing with her. I'm on the fence about it. But the whole concept is to loosen and release from feet to head. So I think what you are doing with your son is as good as anything. I've heard my mentors say that high curves are a nightmare to try and manage, even with a brace. The shoulder girdle just gets in the way and it's hard to make anything fit.

[LindaRacine]

The cost to treat all of the kids in the W&W group is huge. I suspect that there are somewhere in the neighborhood of 300,000-600,000 new cases of scoliosis diagnosed every year in the U.S. The vast majority of those cases are small curves that will never progress to the point of needing treatment. So, let's be conservative, and say that there are 200,000 new cases per year that will never progress. If you treat them all with some alternative treatment (let's use a conservative cost of $1,000 for the first year), just the first year alone will cost $200,000,000. If those kids are put in braces, you can probably quadruple that cost. And, that's just for a single brace. Most kids require multiple braces during their years of treatment. So, if they get braced (at $5,000 each), and are put in exercise programs (at another $1,000 each), we're talking about somewhere in the neighborhood of $1,200,000,000 for just the first year's worth of kids, for one year of treatment. Let's say all subsequent years put together for those 200,000 kids cost about $1,000,000,000. The total cost to treat those kids is $2,200,000,000.

I don't know what percentage of those W&W kids would go on to surgery, but it's got to be tiny. Let's say 5% go on to need surgery (again, probably very conservative, as it's probably like 1%). At $100,000 per surgery, that's $1,000,000,000. If 2% of those 5% go on to need revision (at $200,000 per surgery) , that would be maybe another $40,000,000. So, the worst case scenario for the W&W kids that go on to need surgery is $1,040,000,000.

Until there's some proof that the economics make more sense, I'm dead set against treating the W&W cohor with our already severely strained healthcare dollars.

[hdugger]

We're already bracing kids with curves of a certain size. So, you're double-counting in alternative treatment something that's already a part of standard treatment.

All that's being added is exercise. PT is already standard treatment for other back problems, and it has significantly reduced the cost of treating back problems.

[Pooka1]

We're already bracing kids with curves of a certain size. So, you're double-counting in alternative treatment something that's already a part of standard treatment.

No I think her analysis is starting with some cohort of newly diagnosed kids and then going forward. None of the newly diagnosed kids is going to be already braced and she is then counting the ones in this new cohort who will be braced.

[aterry]

Kevin, you mentioned, "Also, lumbar curves seem to be somewhat resistant". Do you have an inkling of why this is? My daughter has a lumbar curve.

[hdugger]

No I think her analysis is starting with some cohort of newly diagnosed kids and then going forward. None of the newly diagnosed kids is going to be already braced and she is then counting the ones in this new cohort who will be braced.

What I meant is that, bracing is now being offered as part of regular medical treatment. We're discussing the additional cost of alternative treatment. So, the "alternative" treatment for this cohort is exercise. Once/if their curves progress enough to require bracing, they'd enter the traditional "medical" cost. Type of brace doesn't effect this cost, as far as I know.

So, only the cost for exercise ($1000 per child) is new. All of the other costs - bracing and surgery - are the traditional medical costs that we're trying to avoid by prescribing exercise for children with smaller curves.

Beyond that, it's hard to run the evaluation, because Linda's numbers assume every child will be braced, and that's not in accord with any protocol I know. Since I don't have any idea what percentage of children go on to be braced, I can't estimate those numbers at all. But, roughly, the idea is that, if exercise works (big if) you avoid not only the cost of bracing and possibly surgery in children, but you also avoid the burden of other back problems in both pre and post surgical adult scoliosis patients. I can't imagine that those numbers would not work out in exercise's favor (again, if exercise works to keep small curves from progressing).

[hdugger]

Here's the SEAS protocol (if you don't want to read, the summary is that exercise is prescribed in "curves likely to progress" - mainly those of at least 15 degrees. Bracing begins at 35 degrees. So, the additional cost is for children with curves between 15 and 35 degrees - basically, those in the wait and watch group):

"Exercises immediately follow observation alone, and come before bracing106. Several formulae in the literature have been developed to calculate the risk of scoliosis progression, but they have all been derived from populations with a high degree of scoliosis, with the avoidance of surgery being the primary objective. Our aim with exercises is to avoid or at least postpone bracing, and to arrive at the end of growth with a presumably stable curvature (as much as possible far from 30°, so that a value between 20° and 25° can be acceptable).74 Therefore, these formulae cannot be applied, and the risk of progression is considered looking at a combination of factors, including:

- There is evidence of scoliosis progression coming from radiographs and/or clinical changes superior to the known measurement error (5° for radiographs, 2° for Bunnell, 3 mm for hump height);56,120

- The starting radiographic and clinical data are near to previously defined acceptable boundaries (i.e. around 15° Cobb, or 5° Bunnell, or 5 mm of hump);106 these points should be considered provisional and should be better understood in the future with new research;

- There is a very high postural component, as evidenced by an important decompensation and/or by the Aesthetic Index;194

- There are high risks due to other known factors of progression, such as a family history of an important scoliosis, flat back, start of puberty, etc.16,74,169.

On the other hand, i.e., when looking at the highest boundaries for exercise treatment we must consider that as far as we know today, exercises do not reduce the curvature105 (even if recently we ourselves raised some doubts about this hypothesis)119 nor, importantly, change the cosmetic appearance.119 So, exercises should never be proposed (in favour of bracing) when 30° curves have been attained unless the pubertal growth spurt is very far in the future and an important postural component is presumed, with the only aim of postponing (possibly avoiding) bracing.106 Moreover, exercises should be proposed when there are uncertainties regarding the application of a brace, even in curvatures exceeding 25°, and there is the possibility of stability due to the absence of other progression factors and a relatively advanced age. In such cases it is important to decide together with the patient and his/her family. Regardless, due to the very short period of research in this field177 all these points will have to be thoroughly studied and refined in the future.

When a brace has already been prescribed, exercises are mandatory in order to avoid all side effects of bracing, to increase its function, and to allow the spine to be stable during the weaning period and when the brace is abandoned.106,136 These points are thoroughly discussed elsewhere in this chapter."

[skevimc]

Linda raises some interesting points. The cost issue is probably one reason why exercise is not used more. It's not proven so why spend the money? That's very valid.

Some numbers I was able to find... in 2000 there were 40 million 10-17 year olds in the US. Approx. 2.5% of the adolescent population (1 million) have >10° curve. The rate drops dramatically for >20° - .23%. So of the million kids with AIS only about 92k require treatment. 40k require surgery. These are not annual numbers. You could probably divide by 7 or 8 and get a rough annual estimate. But I found that the annual rate is quite sporadic.

I don't think anyone would suggest treating the entire 1 million kids. There are patients with a low risk for progression and those with a high risk for progression. SOSORT has a very thorough treatment guideline relative to progression risk and suggests beginning treatment at >15° and zero to low signs of maturity with exercise therapies first.

If an exercise therapy could reduce the .23% number who require treatment, i.e. bracing, down to .18% that stops 20k kids from getting a brace. That's $100 million ($5k/brace). Offset the cost with the cost of PT by $20 million ($1k/year), that's $80 million in savings that was going to be spent. The crux is to find out how many patients with a high risk for progression, but wouldn't end up progressing, there are in the W&W group. This would be the number of theoretical over spending.

The reason I think treatment needs to start earlier is that >20° the disc and vertebral wedging are significantly increased. Obviously, the less wedging the better. I also feel that exercise has a better chance with these smaller curves. This is also why rotational strength training was so attractive. It's simple, can be taught very quickly and is easily transferred to a home therapy protocol. This would place minimal load on the health care/ insurance system.

I think the economics are there. The data just needs to be stronger.

[Pooka1]

What I meant is that, bracing is now being offered as part of regular medical treatment. We're discussing the additional cost of alternative treatment. So, the "alternative" treatment for this cohort is exercise. Once/if their curves progress enough to require bracing, they'd enter the traditional "medical" cost. Type of brace doesn't effect this cost, as far as I know.

So, only the cost for exercise ($1000 per child) is new. All of the other costs - bracing and surgery - are the traditional medical costs that we're trying to avoid by prescribing exercise for children with smaller curves.

Beyond that, it's hard to run the evaluation, because Linda's numbers assume every child will be braced, and that's not in accord with any protocol I know. Since I don't have any idea what percentage of children go on to be braced, I can't estimate those numbers at all. But, roughly, the idea is that, if exercise works (big if) you avoid not only the cost of bracing and possibly surgery in children, but you also avoid the burden of other back problems in both pre and post surgical adult scoliosis patients. I can't imagine that those numbers would not work out in exercise's favor (again, if exercise works to keep small curves from progressing).

Okay I see what you are saying.

In re your last point... whether or not exercise is effective at keeping small curves small, again, someone correct me if I'm wrong but we are talking the vast majority of curves are small. And according to that Greek study, IIRC at least 25% (or all curves but presumably most small curves) will not only not progress but will decrease spontaneously, some to zero degrees. Taking all the small curves, I think it is fair to say maybe ~90% will never progress to surgery and some large fraction of that number will not progress to brace no matter what you do or don't do.

When the vast majority of a treatment groups (in this case kids with small curves) will never progress to needing treatment anyway, everything will look like it works, including eating ice cream. This is why I am suspicious of the Clear and their push to identify and treat small curves... I think they realize even if the treatment is completely ineffective, it will appear to work almost all the time. And then through word of mouth they will rake in bazillions. How will a PT study ever see a statistically significant difference between 90% apparently cured but who really didn't need treatment and maybe an extra 5% cured though PT? I suggest the population size is not doable to show that.

I exempt legitimate researchers from this criticism because they are trying to be scientific about it and they obviously understand the problem on the table. There is nothing scientific about Clear.

[hdugger]

Thanks, Kevin. Those number make sense to me.

Is side-shifting also useful for those small curves? I'm wonder if we had a few simple, cheap, exercises people could try (and a few is better than one to cover the different types of curves/responses) that might keep them from ever reaching that 20 degree mark, we could reduce the disease burden even further. I guess I'm looking at something that could be easily summarized by a flyer you could get out to those school nurses screening for scoliosis.

Of course, all of these assumes somehow showing that these exercises slow progression.

[hdugger]

Taking all the small curves, I think it is fair to say maybe ~90% will never progress to surgery and some large fraction of that number will not progress to brace no matter what you do or don't do.

Yes, that's what Kevin's numbers suggest.

Clear is obviously (clearly :)) overkill for curves under 15 or 20 degrees. In that range, you really just want some simple, cheap exercise you can explain in a few minutes. You'd have to study the effectiveness of the exercse, though, on larger curves, for the reasons you outline. But, if you can show that a few simple exercises keep some percentage of larger curves from progressing, you might reasonably assume that they'd also work on smaller curves.

The real test of this kind of strategy comes over time and huge numbers of patients in a natural study. If the protocol for small curves changes from 'watch and wait' to "do these exercises" and, over years, the rate of small curves progressing to large curves goes down, then you might suspect that these measures worked. But, yes, it is very hard to prove these kinds of things.

[Pooka1]

You'd have to study the effectiveness of the exercse, though, on larger curves, for the reasons you outline. But, if you can show that a few simple exercises keep some percentage of larger curves from progressing, you might reasonably assume that they'd also work on smaller curves.

Yes but as we have seen, progression even in large curves (viz my one daughter's several month long quasi-stability in the mid-30s*, a period which exceeds the duration of the torso rotation and many other studies), cannot be assumed. That's why I am persuaded by your approach that the only hope to try to see some PT effect is a reduction in a large curve, NOT stability only during a few weeks to months.


The real test of this kind of strategy comes over time and huge numbers of patients in a natural study. If the protocol for small curves changes from 'watch and wait' to "do these exercises" and, over years, the rate of small curves progressing to large curves goes down, then you might suspect that these measures worked. But, yes, it is very hard to prove these kinds of things.

Yes I suspect you are correct.

Here's a thought, isn't there some way to identify kids in the peak height velocity in real time? I think if you can get enough kids determined to be in this stage to participate in even a short-term PT study, it might be significant. Don't know.

[hdugger]

Actually, with something like exercise which isn't part of the standard protocol, it would be far simpler to do a real randomized study. That is, unlike bracing, you're not fighting doctors who feel that they should be prescribing it, or teenagers who are fighting being braced.

So, you could do a simple randomization - one kid gets the exercise treatment and the next kid doesn't - without running into any of the usual ethical questions.

The problems of having a variable course of disease is true of almost all medical issues. (Two people with the same kind of cancer at the same stage, for example, can progress at quite different rates.) A well-designed experiment with an adeqate number of patients should show an effect if exercise actually makes a difference. So, it's not at all hopeless. You just need to get an adequate number of patients. If you could interest some place that sees alot of patients (like Shriners), you could get those numbers pretty easily.

[hdugger]

Identifying peak velocity is a great question. Even having a good handle on which kids are likely to progress would be helpful.

[LindaRacine]

We're already bracing kids with curves of a certain size. So, you're double-counting in alternative treatment something that's already a part of standard treatment.

All that's being added is exercise. PT is already standard treatment for other back problems, and it has significantly reduced the cost of treating back problems.

Nope. I'm saying that there are 200,000 new cases of scoliosis each year where the curves fall outside of the treatment protocol. That is, their curves are too small to warrant treatment.

[LindaRacine]

I think the economics are there. The data just needs to be stronger.

The economics are definitely there if we can identify the kids that are at risk of progression. While most of the group discussing this current topic are talking about exercise alone, there are certainly a lot of the folks who are usually involved in these discussions, who think that all W&W kids should be braced.

--Linda

[LindaRacine]

Okay I see what you are saying.

In re your last point... whether or not exercise is effective at keeping small curves small, again, someone correct me if I'm wrong but we are talking the vast majority of curves are small. And according to that Greek study, IIRC at least 25% (or all curves but presumably most small curves) will not only not progress but will decrease spontaneously, some to zero degrees. Taking all the small curves, I think it is fair to say maybe ~90% will never progress to surgery and some large fraction of that number will not progress to brace no matter what you do or don't do.

When the vast majority of a treatment groups (in this case kids with small curves) will never progress to needing treatment anyway, everything will look like it works, including eating ice cream. This is why I am suspicious of the Clear and their push to identify and treat small curves... I think they realize even if the treatment is completely ineffective, it will appear to work almost all the time. And then through word of mouth they will rake in bazillions. How will a PT study ever see a statistically significant difference between 90% apparently cured but who really didn't need treatment and maybe an extra 5% cured though PT? I suggest the population size is not doable to show that.

I exempt legitimate researchers from this criticism because they are trying to be scientific about it and they obviously understand the problem on the table. There is nothing scientific about Clear.

Well said. Thanks.

[Pooka1]

The economics are definitely there if we can identify the kids that are at risk of progression. While most of the group discussing this current topic are talking about exercise alone, there are certainly a lot of the folks who are usually involved in these discussions, who think that all W&W kids should be braced.


I agree there is a somewhat casual insouciance :) towards bracing kids. Bracing is far from benign and yet I think there are people here and elsewhere who would brace their kid if the chance of avoiding surgery was known and was 1% or even 0.1%. That might have been rational before the pedicle screw era but I think making the ethical case for the rationality of that now is very hard.

[skevimc]

Here's a thought, isn't there some way to identify kids in the peak height velocity in real time? I think if you can get enough kids determined to be in this stage to participate in even a short-term PT study, it might be significant. Don't know.

Accurate record keeping by the doctor's office would be able to calculate this when they come in. If I can remember correctly, 9 cm/yr is considered pretty close to peak for most kids. It would be easy to measure it yourself at home. (Height B - Height A)*(12/number of months between A and B).

We reported PHV. There were 2 who had velocities of 13 cm/yr, one girl one boy. Both had left TL/L, 21° and 31° respectively. Risser II and 0 respectively. Both reduced, 15° and 24°. The girl maintained her correction, risser V. The boy was a yo-yo. He reduced the first interval (26°). Stopped working out, progressed (35°). Started working out again, reduced (24°) - final measurement we had.

Then there were others with PHV ~7cm/yr who progressed by a year or so out.

It's interesting looking at the data again. I haven't for a long time. There were some progressions I hadn't remembered. It makes me remember how confusing and random everything seemed. One girl specifically I think of who did everything we asked of her. Worked out hard. Got a lot stronger after training. Progressed 10° 12 months out. Those are visits where you just want to become invisible. Those are the experiences I remember and become fairly agitated at websites (and other things) that say they have 100% success. They aren't reporting the full story.

[Pooka1]

Okay that was pretty interesting. But isn't peak height velocity as determined by sequential height measurements going to underestimate the velocity in the case of a progressive curve? Maybe it isn't significant enough such that the phase is missed using this approach, I don't know.

[hdugger]

Nope. I'm saying that there are 200,000 new cases of scoliosis each year where the curves fall outside of the treatment protocol. That is, their curves are too small to warrant treatment.

I posted the SEAS protocol, and that's the one I would (personally) recommend. Their protocol has exercise from 15 to 35, and bracing after that. That's an alternative course, but one where the bracing falls within the standard protocol.

Given that protocol, only the cost of exercise for patients between 15 and 35 degrees would be added to the current protocol. I think Kevin's post breaks down those costs very well.

All of this, of course, is for AIS only. The risk of progression for JIS is so elevated that you might have to shift the treatment window much earlier in order to keep those kids from progressing.

[Pooka1]

Given that protocol, only the cost of exercise for patients between 15 and 35 degrees would be added to the current protocol.

When you consider the BRAIST researchers appeared to have been browbeaten into lowering the bracing limit from 25* to 20*, I bet there are many parents who will not consider waiting until 35*. Just my impression.

[hdugger]

I suspect some of that has to do with parents' feeling that they should be doing *something* instead of just waiting. Perhaps if they had something else they thought was effective for those smaller curves, they would be willing to wait to start bracing.

[Pooka1]

I suspect some of that has to do with parents' feeling that they should be doing *something* instead of just waiting. Perhaps if they had something else they thought was effective for those smaller curves, they would be willing to wait to start bracing.

I don't know about other folks but I want the surgeon to pick the treatment based on evidence. This is his field, not mine and I'm paying him (or the insurance company is). I don't think my feelings enter into the science of it. And when he departs from evidence, I want to know about it and have some idea how large the departure is. I have exactly ZERO mental need to treat my kid other than what the surgeon says is worth a try, especially when it comes to something as difficult as bracing. But that's just the kind of hairpin I am. :D

[hdugger]

I think people just have different natures. I have an experimental nature, so I'm always willing to run an experiment of one. I try not to go *against* doctor orders, but I also do a fair amount of reading to figure out if I can do something to augment whatever treatment I'm given (assuming the treatment itself isn't immediately curative.)

I like science, but I know there's only so much money and time to go around, and it could take a very long time for science to get to my particular concerns.

[Pooka1]

Still no clear pubs and none seemingly contemplated.

Please refer to initial post in this thread.

I will be updating this thread every 6 months.

[rohrer01]

Are there any peer-reviewed Clear papers? I can't find any.

Here's an unpublished study frm Clear...

http://www.clear-institute.org/Portals/0/docs/ScoliosisCorrection.pdf




You are kidding right? That paper wouldn't even be allowed as evidence in a college paper, let alone peer reviewed! They didn't even use the same vertebrae, which in and of itself invalidates the whole thing. I do agree with them NOT to break things free by adjusting the "high side of the rainbow". This is what they TEACH chiros to do. This is exactly what my chiro did, and I progressed.

[Pooka1]

You are kidding right? That paper wouldn't even be allowed as evidence in a college paper, let alone peer reviewed! They didn't even use the same vertebrae, which in and of itself invalidates the whole thing. I do agree with them NOT to break things free by adjusting the "high side of the rainbow". This is what they TEACH chiros to do. This is exactly what my chiro did, and I progressed.

I did say it was an unpublished study. It goes without saying it is also unpublishable in the peer-reviewed journals. It is Exhibit "A" in why chiros aren't qualified to treat people.

[hdugger]

They didn't even use the same vertebrae, which in and of itself invalidates the whole thing.

Not a comment on the paper, but our orthopedic surgeon doesn't necessarily use the same vertebrae from visit to visit. I think that's considered normal procedure in this field - they're looking for the curve, not measuring between specific vertebrae.

[jrnyc]

awww.....Sharon...some 5 months later and you guys still havent chosen a Pub to go drinking in...:rolleyes:

it's summer...perfect time for a "pub crawl"!!

i have no patience right now for any other kind of "pub"..havent since i got my last graduate degree!

:p

[Pooka1]

awww.....Sharon...some 5 months later and you guys still havent chosen a Pub to go drinking in...:rolleyes:

it's summer...perfect time for a "pub crawl"!!

i have no patience right now for any other kind of "pub"..havent since i got my last graduate degree!

:p

Excellent points.

And here we are ANOTHER day later and still no Clear pub that was promised. :D

[Pooka1]

Coming up on 8 months and I think we might stop waiting... a Clear chiro has recently admitted there is no evidence their approach works.

Further, he claims approaches should be judged just on their perceived merit as opposed to evidence. I guess by that he means like the swimsuit competition in beauty pageants as opposed to the talent portion.

I might still update this thread depending on how the feeling strikes me. But I think the point of waiting for a pub on evidence that Clear is effective is not going to pan out.

[Pooka1]

There was mention of a 140 patient study from Clear that is being readied for submission to some chiro journal per Josh Woggon. But he anticipated it would get picked apart. Hmmm. And we can presume the other Clear chiros have read it and at least one still admits there is no evidence Clear works. Moreover, he doesn't want Clear to be judged by their results, only the "merits" of the approach. I don't see how that helps in this case, though.

[Pooka1]

Oh no actually I think this is the same one that was completed in February 2010.