Clear - Even lay parents are eating their lunch

[Pooka1]

I just felll over.

Some pertinent comments from Michael1960 to Stitzel...

In regard to an inane "equation" Stitzel uses to dumb down scoliosis treatments for us non-chiros...

You are killing me with your logic. There are many unknowns. Don't we wish we had only 2.

Let me ask you. How do you know which CLEAR treatment is working: wobble chair, traction chair, eckard table, pettibon weights, vibration, posturemed, etc. (not sure if CLEAR uses all of these). But I bet there must be at least 10 unknowns in the CLEAR treatment. And this does not even take into consideration the traction chair and its lack of controls to make sure it is positioned properly and tightened properly (especially when used by the patient at home). Heck, there are several unknowns with just the traction chair. Not only the proper fitting and proper tightness, but what about the vibration frequency and amplitude. You are assuming your vibration frequency and amplitude are correct for every single patient. Ugh!! Vibration theory is very tricky and questionable. I believe you have no idea how much each treatment and how much the vibration contributes or takes away from the end result. My approach has many less unknowns in it than the CLEAR process. Wow. Can't believe I just came up with that. You are giving me a hard time about unknowns, and you have introduced more unknowns in the CLEAR process than I can count on my fingers and toes!

Vibration theory. Unknowns. This is why Stitzel is in over his head with an engineer. Way over his head with any technically trained person. Stitzel simply doesn't know what he doesn't know. He goes into his basement and builds a traction chair or modifies a handheld jigsaw. Then he brings it into the office without any testing or thought about how or why it should work for "cure" (his word) scoliosis and they charges bunnies to experiment on them with these things.

[Pooka1]

First, I don't always follow your analogies. I see no logic in comparing CLEAR and Bracing to red bull and vodka, other than an example to try and support your view.

If you read Fix's site, all those chiro types are constantly using inane analogies I suppose in an effort to understand the concepts themselves but probably also to "dumb it down" for non-chiros. They must teach "Inane Analogies 101" in chiro college given the frequencies with which all those guys seems to use them. It's like a substitute for rigorous thought.

Rather than needing to "dumb down" chiro concepts they should be gathering evidence for their claims. I don't know how much of chiro or how much of the chiro community working on scoliosis is evidence based but I think it is far from 100%. Morningstar is evidence-based and is an excellent science writer to boot in my opinion. This guy could publish in the legit medical literature in my opinion though this is not my field and I really don't know.

[Pooka1]

No answer yet to these important questions about Clear...

http://www.fixscoliosis.com/threads/...based-medicine

I am going to bullet out Michael1960's pertinent questions and report back if Stitzel answers any of them. These questions are:

1. What study or evidence is available that I can read that shows CLEAR works, and that it continues to work for the child into adulthood?

2. How long has CLEAR been in existence? How many patients (JIS or AIS) are now adults?

3. What are the results of 5-10 years into adulthood? Let's assume we need results of an AIS child, with an aggressive curve, who is now at least 20-25 years old. Has CLEAR been around long enough to present studies on this (compared to the numerous bracing studies).

4. If there is a study, by CLEAR Institute, or some other organization, is there an independent study to validate it? Often the creators of a treatment have a valid study, only to have it invalidated by an independent study. And the independent study is the one that seems to get the most credit for being right. For example, I know you have made references to Weiss regarding the SpineCor study.

5. Is there data/study that shows an aggressive curve of an AIS (10-12 yr olds), maybe 35-45+ degrees, how much the curve was reduced, and what happened as he or she went through the growth spurt years (maybe 11-13 for girls, maybe 13-16 for boys). And was the reduction maintained? What kind of treatment was required before and after the growth spurt? And what are the results the following years into adulthood? For bracing, many of these questions are answered, and unfortunately, not many good results. But can CLEAR claim positive results in comparison to bracing, VBS, or any other treatment? With no study, it is hard to validate and/or compare CLEAR to other treatment methods.

6. Also, with CLEAR, it would be good to see results based on 2 week intensive programs and home exercises versus an onging weekly treatment program throughout the year and home exercises. Does this exist? What is your opinion on what is most effective?

7. What is success defined by CLEAR? How would you define a successful CLEAR treatment of an AIS patient? curve reduction, stop curve progression, avoid surgery, reduce pain, etc.

[michael1960]

Below are my questions regarding CLEAR and the responses from Dr. Woggon, Director of Research, CLEAR Institute.

1. What study or evidence is available that I can read that shows CLEAR works, and that it continues to work for the child into adulthood? The first study on our methods was published in BMC Musculoskeletal Disorders in 2004. It is an Open Access publication, and can be viewed at: http://www.biomedcentral.com/bmcmusc...viewedalltime/
A follow-up to this article to report on the long-term results has been submitted and is currently awaiting acceptance in a peer-reviewed journal.

2. How long has CLEAR been in existence? How many patients (JIS or AIS) are now adults? CLEAR Institute was founded in 2000. The original purpose of the organization was to help chiropractors become better doctors through advanced adjusting techniques and precision x-ray analysis. When CLEAR was founded, we did not focus on working with scoliosis. The organization evolved over time to match its talents with the needs of its patients. It was not until 2003 that we began working in detail with scoliosis patients and teaching seminars on scoliosis at Parker College of Chiropractic.
Only those patients who were eleven years of age or older who began treatment with CLEAR Institute in 2003 would now be adults. At the time, there were only three clinics utilizing the CLEAR protocol (including my father’s, where I worked alongside him). I would estimate the number of people who we treated as adolescents in 2003 who are now adults to be perhaps a few dozen or so. All who have not been lost to follow-up are a part of the second study.

3. What are the results of 5-10 years into adulthood? Let's assume we need results of an AIS child, with an aggressive curve, who is now at least 20-25 years old. Has CLEAR been around long enough to present studies on this (compared to the numerous bracing studies).
Yes, CLEAR Institute has been around long enough to present case studies to answer this specific question. In 2003, many of the patients whom I worked with personally were 13-15 years of age. In 2007, they would be 20-22. Again, all who have not been lost to follow-up are included in the second study that is currently awaiting acceptance.

4. If there is a study, by CLEAR Institute, or some other organization, is there an independent study to validate it? Often the creators of a treatment have a valid study, only to have it invalidated by an independent study. And the independent study is the one that seems to get the most credit for being right. To-date the only published study on CLEAR Institute’s methods is the one referenced above. One of the reasons my father & I established the CLEAR Scoliosis Clinic on the campus of Parker College of Chiropractic in Dallas, Texas, was to benefit from the resources of the Parker Research Department in conducting independent studies.

5. Is there data/study that shows an aggressive curve of an AIS (10-12 yr olds), maybe 35-45+ degrees, how much the curve was reduced, and what happened as he or she went through the growth spurt years (maybe 11-13 for girls, maybe 13-16 for boys). And was the reduction maintained? What kind of treatment was required before and after the growth spurt? And what are the results the following years into adulthood? For bracing, many of these questions are answered, and unfortunately, not many good results. But can CLEAR claim positive results in comparison to bracing, VBS, or any other treatment? With no study, it is hard to validate and/or compare CLEAR to other treatment methods.
Yes, I have data on very similar instances that I am currently compiling into a retrospective case series. However, one of the caveats of a ten-year study is that it takes ten years to produce, and the first patients treated using the CLEAR methods were treated in 2003.
It should also be noted that CLEAR’s protocols did not spring fully-formed into existence; they were continually developed and refined into what has now become known as “CLEAR Treatment.” Five years from now, “CLEAR Treatment” could involve a very different set of exercises & therapies as we continue to strive to learn & improve. This makes long-term controlled studies (those at a higher level of evidence than case reports) very difficult to produce, because patients would be required to adhere to the same set protocols in the beginning of the study as they did in the end. If a new, more effective therapy was created in the meantime, the patients enrolled in the study would not be allowed to benefit from it, as this would compromise the validity of any conclusions made in the study regarding the effectiveness of the specific treatment protocol being evaluated. In my experience, no matter how badly someone clamors for more research on the CLEAR methods, that individual would prefer to drop out of the study and receive the best possible care when it’s their own spine on the line.
Although you may believe bracing has been proven to be ineffective (or effective), according to the strict standards of research, its efficacy has not been proven or disproven, and the BrAIST study will not provide an answer to this question either. A common problem with all of the current studies on scoliosis today is that they attempt to solve an equation with two unknowns; this is an algebraic impossibility. In essence, the best study on the best treatment system in the world can be invalidated by six words: “They would have gotten better anyway.” When resources are limited, you do not want to waste them in repeating a flawed experiment. In order for any study evaluating the efficacy of a particular treatment to be valid, the patients must first be risk-stratified. In other words, there must be proof that the curve would have gotten worse in the absence of treatment.
CLEAR Institute currently requires all certified doctors to provide access to the ScoliScore prognostic test to all of their patients; using this test, we can follow the natural history of a high-risk case of adolescent idiopathic scoliosis into adulthood and determine if the CLEAR treatment was truly effective in altering the course of the condition. If we are successful, it will be the first time that a treatment has been proven through research to positively alter the natural history of scoliosis (note to those unfamiliar with research: spinal fusion surgery as a treatment for scoliosis is not considered to alter the natural history of a scoliosis, because the scoliosis has already progressed to severe enough levels to warrant the intervention. Methods such as VBS and VEPTR are aimed at doing so; however, they will still need to prove that the operated patients would have developed a severe scoliosis if the intervention had not been performed).

6. Also, with CLEAR, it would be good to see results based on 2 week intensive programs and home exercises versus an onging weekly treatment program throughout the year and home exercises. Does this exist? What is your opinion on what is most effective? Yes, this is a very good question, and one of the first I set out to answer once I began collecting data from all of the CLEAR clinics. The answer, simply stated, is that the 2 week program is more effective at achieving better results in the short term, but the permanence of the achieved results is better with long-term programs. Patients who participate in the 2 week Intensive Care treatment plan come from out of town; when they return home, they are on their own to do their exercises and follow through with the prescribed rehab. Compliance thus tends to be poorer on average, and with poor compliance comes poor results – whether you’re talking about bracing or CLEAR.

7. What is success defined by CLEAR? How would you define a successful CLEAR treatment of an AIS patient? curve reduction, stop curve progression, avoid surgery, reduce pain, etc. Personally, if a treatment did not improve lung function, cosmetic appearance, and overall health & well-being, but the Cobb Angle decreased, I would consider the treatment to be a failure overall. The goal of CLEAR treatment is to empower people to be able to lead functioning, pain-free lives. In a mild case of scoliosis, this translates into reducing the biomechanical factors that influence the progression of the curve to ensure that the scoliosis does not develop into a severe spinal disorder in adulthood. In a severe case of scoliosis, a successful treatment would be defined by providing the best possible quality of life for that specific person.
Outcome measurements used by CLEAR clinics include quality of life questionnaires (RAND SF-36 and the SRS-22), spirometry (lung capacity), scoliometry (rib arching), dynamometry (grip strength testing), algometry (muscle strength testing), inclinometry (range of motion testing), balance & proprioception tests, and, of course, radiography (Cobb Angle). Everything we measure, we want to see improve.
While every CLEAR doctor measures and records Cobb Angle, we also recognize that it is a two-dimensional representation of a three-dimensional spinal disorder. In one of the research articles I am currently working on, I set out to measure & record practically every radiographic variable affiliated with scoliosis treatment – Disc Index, Harrington factor, intercrestal line deviation, the Risser-Ferguson angle, and many more. The data reflected an improvement in every variable. While this data will be considered observational once it is published in a case series, I believe it to have promising implications for future controlled research studies aimed at determining a causal relationship.

Warm Regards,
Dr. Josh Woggon
Director of Research, CLEAR Institute
jwoggon@clear-institute.org

[Pooka1]

Well, Josh Woggon is certainly capable of clear concise scientific writing. Most of this is also well reasoned in my opinion with a few exceptions. Kalla blocked me from the fixscoliosis site although Stitzel said I could continue. Whatever, I'll comment here.

Although you may believe bracing has been proven to be ineffective (or effective), according to the strict standards of research, its efficacy has not been proven or disproven, and the BrAIST study will not provide an answer to this question either. A common problem with all of the current studies on scoliosis today is that they attempt to solve an equation with two unknowns; this is an algebraic impossibility. In essence, the best study on the best treatment system in the world can be invalidated by six words: “They would have gotten better anyway.” When resources are limited, you do not want to waste them in repeating a flawed experiment. In order for any study evaluating the efficacy of a particular treatment to be valid, the patients must first be risk-stratified. In other words, there must be proof that the curve would have gotten worse in the absence of treatment.

Need to drop the algebraic equation motif. Not appropriate. There are far more than two variables. This is way more complex.

Also, the "they would have gotten better anyway" comment can be lessened by having large treatment cohorts and comparing to what is known of the natural history. That said, I agree this will likely always be an Achilles heel in this research due to the high intrinsic variability of the condition.

Also, while BRAiST is just a start, it will provide some rudimentary answers.

CLEAR Institute currently requires all certified doctors to provide access to the ScoliScore prognostic test to all of their patients; using this test, we can follow the natural history of a high-risk case of adolescent idiopathic scoliosis into adulthood and determine if the CLEAR treatment was truly effective in altering the course of the condition.

There is a precision and bias associated with Scolioscore as there is with any predictive analysis. That has to to be kept in mind when labeling people as low or high risk. The test has some error that hopefully has been quantified.

(note to those unfamiliar with research: spinal fusion surgery as a treatment for scoliosis is not considered to alter the natural history of a scoliosis, because the scoliosis has already progressed to severe enough levels to warrant the intervention.

Fusion stops future progression and reverses some or most of past progression, both of which alter the natural history. So that statement is incorrect as is the claim that fusion doesn't address cosmesis mentioned by Woggon elsewhere.

[skevimc]

Has this forum blocked them from signing up? I'm curious why Dr. Stitzel said he has been blocked. I know I tried to sign up about two years ago and I was having trouble doing it. I assumed it was something to do with my work computer. At any rate, I was able to sign up several months later and contacted Linda about who I was, i.e. a scoliosis researcher, and she seemed happy that I would choose to identify myself and participate in the discussion. Is there some other reason he was blocked or feels that he is being censored?

It's also odd to me at how defensive his posts became when responding to michaelb's comments. There's 'spirited' debate. And then there is calling someone 'borderline arrogant' who has taken lots of time to self-educate and is now challenging your assertions. (Not to mention the use of excessive punctuation. But that's just a pet peeve of mine when trying to make serious debate.)

Overall, it was a pretty interesting thread to read, even if it seemed to be overly harsh to the NSF forums. I enjoyed Morningstar's input. Although I have a problem with his statement about relying on academic researchers to piece apart the things that appear to work clinically. That he's not concerned with which modality works, just that his methods prevents surgery. That leaves us to guess which modality to leave out. And then when we don't get the same results our report is discounted because we didn't do the exact (patented) method. Case in point, in his 2004 report he mentions that manipulation alone does not significantly alter the curve and that caution should be used when manipulating patients because unpublished clinical observation shows that over-manipulation can be harmful, yet still says that manipulation, combined with other rehabilitation procedures, should be used. Seems like manipulation is being heavily discounted, with literature and experience, yet is still encouraged to be part of the treatment paradigm.

[Pooka1]

It's also odd to me at how defensive his posts became when responding to michaelb's comments. There's 'spirited' debate. And then there is calling someone 'borderline arrogant' who has taken lots of time to self-educate and is now challenging your assertions. (Not to mention the use of excessive punctuation. But that's just a pet peeve of mine when trying to make serious debate.)

Most of the time he seems to keep it together and seems reasonable. Occasionally he lashes out in a non-rational manner like the example you cite above. Michaell1960 has clearly put in a lot of time crunching this information and has churned out a series of very cogent posts here and on fix's forum. He rose to the head of the class in my opinion and in short order. Michael1960 should not be a target of that.

Overall, it was a pretty interesting thread to read, even if it seemed to be overly harsh to the NSF forums. I enjoyed Morningstar's input. Although I have a problem with his statement about relying on academic researchers to piece apart the things that appear to work clinically. That he's not concerned with which modality works, just that his methods prevents surgery. That leaves us to guess which modality to leave out. And then when we don't get the same results our report is discounted because we didn't do the exact (patented) method.

I'm not sure I completely understand your point but an empirical result is just as good as an established etiology to a patient. The manic depressives on lithium are still helped although nobody knows the biochemical pathway(s) involved.

Case in point, in his 2004 report he mentions that manipulation alone does not significantly alter the curve and that caution should be used when manipulating patients because unpublished clinical observation shows that over-manipulation can be harmful, yet still says that manipulation, combined with other rehabilitation procedures, should be used. Seems like manipulation is being heavily discounted, with literature and experience, yet is still encouraged to be part of the treatment paradigm.

Well, he thinks he has evidence that manipulation is only good when combined with some other stuff I guess. I also think he might be trying to carve out an area apart from traditional chiro which has been discredited evidence-wise. These chiro types working with new approaches should be given some leeway to prove up their case if they are evidence-based.

[mamamax]

Kalla blocked me from the fixscoliosis site although Stitzel said I could continue. Whatever, I'll comment here.

Just an FYI - your membership has not been blocked. I presume you know this as you have logged in.

[mamamax]

I think Dr. Woggon deserves a great deal of respect for the manner in which he answered these important questions and that his responses serve to better educate us all.

If anyone is interested in one-on-one discussion directly with him, he has opened the topic for discussion here: http://www.fixscoliosis.com/threads/...ka1-s-Response

[Pooka1]

Just an FYI - your membership has not been blocked. I presume you know this as you have logged in.

Mamamax you are clueless here.

I can log in but get sent to a splash page saying the server is busy.

And it takes forever to get to the splash page.

Yesterday, it churned and churned and let me get to a few pages but still sent me to the splash page several times.

Obviously I am on some type of block as none of this crap ever occurred before.

I just tried it again now. I am still on some sort of block or manual moderation of even which thread I want to read. I get there but only after a several second delay.

I just hit "New posts" and got routed to a yahoo page saying the page didn't exist.

You are clueless.

[Pooka1]

Mamamax, supergenius wrote:

Maybe Pooka1 (Bambi over here), will be brave enough to engage discussion with you one on one.

How the hell can I be "brave enough" when they are screwing around blocking me or hand moderating me or whatever the hell they are doing?

Genius.

[skevimc]

I'm not sure I completely understand your point but an empirical result is just as good as an established etiology to a patient. The manic depressives on lithium are still helped although nobody knows the biochemical pathway(s) involved.

Yeah, I just re-read what I wrote and... umm... yeah.. what was I saying?

Anyway, to try and clarify, Morningstar said he would leave it to the academic researchers to determine which parts of a complex protocol are the most effective and/or how they work. And that his main concern was whether his therapy kept patients from surgery. I understand and agree with his point to a certain extent. And was told the same thing countless times by some people on my dissertation committee when I would push for a more mechanistic understanding.

My critique is that, 1. charging significant money for these treatments with limited publication is questionable. 2. When research shows that one thing doesn't prove effective the argument can always come back as "well you didn't include it with 'x' so that's why it didn't work". Which you mention below, i.e. manipulation in combination with other things. 3. Without knowing more about treatment A, it's really difficult to say that treatment B should be avoided. However, I do give Morningstar a lot of credit for the sound theories. He has legitimate arguments for doing what he does (at least accoring to the 2004 paper). It's one thing I've always liked about the Clear, and other, method(s). Neuromuscular re-training is a strong position for sure and I have definitely drunk that kool-aid. It's just when I read 'manipulations can be bad but we'll still do them' and then charging patients' families ~$15k for therapy and equipment then just writing them off as non-compliant if they don't follow or pay for every single thing, bothers me. (Not to mention genetic testing for which I can find no peer reviewed publication (Scoliscore). Anyone please post a link if one exists).

Well, he thinks he has evidence that manipulation is only good when combined with some other stuff I guess. I also think he might be trying to carve out an area apart from traditional chiro which has been discredited evidence-wise. These chiro types working with new approaches should be given some leeway to prove up their case if they are evidence-based.

I agree with any form of therapy that strives for evidence based approaches and give them an enormous amount of leeway. (Indeed, my own studies need that.) I struggle with charging patients for that therapy while collecting evidence. And that goes for any form of therapy, exercise or chiro or surgery or drug.

[Pooka1]

Anyway, to try and clarify, Morningstar said he would leave it to the academic researchers to determine which parts of a complex protocol are the most effective and/or how they work. And that his main concern was whether his therapy kept patients from surgery. I understand and agree with his point to a certain extent. And was told the same thing countless times by some people on my dissertation committee when I would push for a more mechanistic understanding.

Well I think it is self-limiting to a certain extent. If the protocol is too complex, people won't try it because they think they can't stick with it. In that case, it would behoove Clear to figure out which, if anything, is effective. If the protocol is effective, it is possible that everything is required. Nobody knows.

My critique is that, 1. charging significant money for these treatments with limited publication is questionable.

Yes i have pointed this out many times. I think they could charge if they were straightforwardly honest that there were experimenting on people. Actually they are quite open about this on the forum so maybe they are open about it in person. I think there is such a gaping well of fear towards surgery that they can get people to pony up significant scratch even admitting it is experimental. The bunnies do not know the score about surgery.

2. When research shows that one thing doesn't prove effective the argument can always come back as "well you didn't include it with 'x' so that's why it didn't work". Which you mention below, i.e. manipulation in combination with other things.

Okay I didn't realize they were saying that. That is clearly wrong because they don't know that combining it with "x" would have worked.

3. Without knowing more about treatment A, it's really difficult to say that treatment B should be avoided. However, I do give Morningstar a lot of credit for the sound theories. He has legitimate arguments for doing what he does (at least accoring to the 2004 paper). It's one thing I've always liked about the Clear, and other, method(s). Neuromuscular re-training is a strong position for sure and I have definitely drunk that kool-aid. It's just when I read 'manipulations can be bad but we'll still do them' and then charging patients' families ~$15k for therapy and equipment then just writing them off as non-compliant if they don't follow or pay for every single thing, bothers me.

I didn't know that was happening. That is wrong. They have no evidence for traction chairs or handheld modified jigsaws. It shocks my conscience if they are browbeating people until buying stuff like that.

(Not to mention genetic testing for which I can find no peer reviewed publication (Scoliscore). Anyone please post a link if one exists).

Hasn't Ogilvie published that in the peer-reviewed literature ahead of charging for the testing? If not they nobody should be using it. The error on the test needs to be known and communicated to the patients.

I agree with any form of therapy that strives for evidence based approaches and give them an enormous amount of leeway. (Indeed, my own studies need that.) I struggle with charging patients for that therapy while collecting evidence. And that goes for any form of therapy, exercise or chiro or surgery or drug.

Well, if they are up front that people are being charged for experimental treatment then it is okay to a certain extent. But these bunnies probably have the wrong idea about surgery or their propensity to progress if they are going to pay thousands and thousands for experimental protocols.

[skevimc]

Hasn't Ogilvie published that in the peer-reviewed literature ahead of charging for the testing? If not they nobody should be using it. The error on the test needs to be known and communicated to the patients.

I can't find anything verifying the test specifically.

From the website:

ScoliScore™ was developed by utilizing a genome wide association study that identified a panel of 53 genetic markers associated with severe curve progression. This scoliosis research involved collecting DNA samples from over 9,500 patients from 85 clinical sites throughout the world. The test was then further validated in two separate clinical trials.

No references linked or listed on this page. In the 'publications' page there are a handful of SRS presentations which usually have a mini-publication associated with it. And a few other meeting presentations as well. But there is only one manuscript in an actual journal from 2006. Certainly nothing showing data from 9500 patients or anything listing 2 clinical trials. It just seems like this data would be published. But maybe I'm just not able to find it because I'm looking under the wrong search criteria. Although it seems if these publications existed the axialbiotech website would link them.

[Pooka1]

I can't find anything verifying the test specifically.

From the website:


No references linked or listed on this page. In the 'publications' page there are a handful of SRS presentations which usually have a mini-publication associated with it. And a few other meeting presentations as well. But there is only one manuscript in an actual journal from 2006. Certainly nothing showing data from 9500 patients or anything listing 2 clinical trials. It just seems like this data would be published. But maybe I'm just not able to find it because I'm looking under the wrong search criteria. Although it seems if these publications existed the axialbiotech website would link them.

Remarkable. How do patients know the bias and variability? How do they know how much to relax or worry with a given score? I wonder if that information comes with the test kits. I certainly hope so.

I can say there was a testimonial on here a while back with a low score that progressed a lot.

There is an error on each score and it needs to be known. I hope people don't think this test is an accurate forecast of the future.