Clear data pub count down

[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.

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]

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?

[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]

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...-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.

[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

[hope404]

cheesy

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.

[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.

[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...

[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.

[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.

[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.

[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/Porta...Correction.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?

[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."