Questions fo rour Clear Chiro, Smith

[jrnyc]

wish we could glimpse the future...50 years or so...
but then again, we might feel a little bit bad if we see incredible things...like flexible strong rods, or a way to switch scoli mid course...REALLY switch it! like reversing the curves before they get large...withut having to move to the other side of the equator!

for those who need ANY kind of surgery, i think minimally invasive will be the surgery of the future...and it will probably get even better from there!

ahhh, to see down the road....

jess

[livingtwisted]

how can anyone be called a "success" unless followed....for years...?

I often wonder this too and I don't think any of the existing treatments -- exercises, bracing, surgery -- could be considered 100% permanent in all cases. The reality is that even if you're pain free or looking straight today, if you have scoliosis, there's no guarantee it will stay that way. The norm -- although, Jess you are an example that it's not always the case -- is for progression to slow after you stop growing, which is why it is treated so aggressively in young people, but it never really stops progressing if you consider degeneration.

In my case I have been a surgical candidate since my teens. And I probably would have bounced right back (and with a straighter back) if I had opted for it. But I have been mostly pain free my whole life and only recently have been more conscious about avoiding certain activities. It's possible that I will be able to stay this way for years. So say eventually my pain increases and I end up having surgery at age 50. In an alternate universe, the fused teen version of me may have also been fine for years, and still needed revisions at age 50. So can that first surgery still be considered a success? If so, is leaving it untreated that long also a success?

[livingtwisted]

hdhugger,

Agreed. But to take that logic one step further... my understanding is that most teens are pain free so they wouldn't need treatment to continue to live pain free in the short term. It is more to prevent any problems in the future. Which is where things get fuzzy since you won't know if it didn't work until you grow up and have pain. And from what we know, severity of pain is not related to the severity of the curve. So why do we think that correcting the physical deformity is a marker for future success? Of course, what hasn't been mentioned is that physical deformity regardless of pain also impacts quality of life.

[Ballet Mom]

how can anyone be called a "success" unless followed....for years...?
where will some of those kids be in 10 years...20...30...?
if they need surgery at age 30, 40 or 50, are they still a "success"?
i think you are right, BalletMom...exactly when is someone declared a "success" ?
is not needing surgery before age 21 a "success"? or age 30?
maybe a "temporary (for now) success" is a better expression...

i do not believe bracing is the answer...but i was never braced, as my scoli wasn't found early...i also avoided doctors like the plague for many years in my late teens and early twenties..
no one wants a child to suffer needlessly, least of all their parents! i think a better option for young kids with scoli is still out there, waiting to be discovered...

i am one of the ones who had curves progress later in life...don't know if anyone would have predicted it would happen...
and the ballet i studied when i was young didnt make a difference...

jess

Yes, I absolutely consider my daughter a success. And her orthopedic surgeon has told us that the likelihood of her progressing in the future is extremely small. I am willing to live with a little risk in life...there are no guarantees on anything, including having surgery young and hoping to avoid revision surgery later on in life...even thoracic curves. And there is certainly risk in surgeries themselves, as you know.

I have also posted studies that showed that braced kids who end up with curves in the thirties have many, many years of no progression at all for decades, and may very well stay that way for good. Ballet didn't stop my daughter's progression either, but with a brace, I believe the stretching of the spinal ligaments has helped her to get through her growth with her brace...successfully.

And yes, we are all waiting for the better option to be discovered. I have done what I can to help by posting my daughter's experience with both bracing and medicine taken and the results obtained.

[jrnyc]

i managed for decades without pain, and then for another decade with little pain...
the difficult thing is to have a lot of pain and worsening of progression at an older age, because infirmities often come later in life, and that is when one's health is not at the most optimum level...so it can be a lot to deal with, if one's back is bad, then the knees go, and who knows what is next! not that scoli is easy at ANY age...

if, as the doctors and surgeons tell me, many/most adults are more likely to herniate disks at an older age, then those with scoli may be at risk at that point, because progression can accelerate with the hernation, as it did for me...and so can the pain!

i am not knocking living with a small curve for many years without trouble...just saying that it makes one more vulnerable...at any age...if any injury happens to the spine...

oh...i think maybe it is time to change the name of this thread...?

jess

[Pooka1]

Yes I wish the thread can be renamed to reflect that Dovorany actually did answer a bunch of questions.

As for Katz et al., bracing efficacy is still a mostly open question. This paper is discussed a bit here...

http://www.scoliosis.org/forum/showt...g-IS-effective!

Here is a commentary pointing out some limitations which the authors acknowledge in their response...

http://www.ejbjs.org/cgi/eletters/92/6/1343#11803

Here is a commentary by our Scoliscore buddies on Lonstein and Carlson (the natural history data that Katz et al. reference in re their own data to claim brace wear beats history) which includes the following quote...

http://www.scoliscore.com/scoliscore...1984Study.aspx

"Given these extensive limitations, use of Lonstein-Carlson criteria to predict curve progression is just slightly better than the random chance of assessing progression by flipping a coin."

And this highlights the general issue of not being able to use the Katz et al. results for predictive purposes. First of all, you can't state anything about comparisons with natural history with any set of results without matching up numbers of various curve types. Look at Carlson and Lonstein and other papers for why that is so. It makes no sense to state something beats natural history until you know the mix of curve types in each data set. For all we know, the most dramatic differences seen in Katz et al, were associated with small groups with most of the eight L curves. They did NOT state this for some reason so it remains a point of criticism. Actually they didn't state a lot of things that are needed to evaluate the data in my opinion.

Second, the ONLY visual hint of the HUGE variability in the Katz et al. data is seen in one graph in the supplemental section. In the main paper, the editors let them get by with no indications of how large the error bars and confidence limits are. This is again an editing problem. They only had 100 patients; it could have easily been shown on one graph. I have shown more points than that on one graph. They "binned" the data into groups to highlight the largest differences between means WITHOUT showing error bars in the paper. But I bet if they plotted all the data on one scatterplot, it would become obvious why you can't use this in a predictive fashion and why PLENTY of kids who follow directions and wear the brace for at least 12 hours will still get kicked in the teeth and go on to surgery. Knowing the range, a parent can't in good conscience tell a kid they have a good chance of avoiding surgery if they wear the brace the prescribed time. They just can't. There is a reason we quantify not just central tendency but also precision. Katz et al. largely avoided discussing precision for a reason.

Third, there is some indication that bracing only delays rather than avoids surgery. This is mentioned in the Price commentary and nothing in Katz et al. can address it... (emphasis added)

The true value of a treatment must be judged by the intent-to-treat for all patients who enter the study. All treated patients are then compared to a group of untreated patients. It should be noted that 28 of the 100 patients who entered this bracing study progressed to surgery during the period of study. Goldberg et al. (2), who did not utilize bracing as a treatment method, reported a 29% rate of surgery in premenarchal girls with scoliosis of 20°-40° at the time of presentation. Price et al. (3) reported a 22% rate of surgery in long-term study of night time bracing for scoliosis.

While Katz et al. have demonstrated that compliance correlates with curve stability, that observation does not necessarily indicate that bracing influences the outcome of scoliosis.

It would be very helpful if they clearly showed how many kids are in each bin. With only 100 patients, some of those bins are going to have a relatively few kids and the results are not necessarily going to be reflective of the big picture over large numbers of patients given the variability.

I think if they were asked by the editors to show and address the variability in every graph, they would have toned down their discussion and it would be obvious that you can't really use these results to predict avoiding surgery with is arguably the bottom line.

Just my opinion.

[dovoranydoc]

"Given these extensive limitations, use of Lonstein-Carlson criteria to predict curve progression is just slightly better than the random chance of assessing progression by flipping a coin."[/COLOR]

.

Unfortunately most studies will be disregarded unless the genetic profile is included in the research.

The scoliosis community will play a tennis match back and forth with one group saying it works and the other saying it doesn't.

If an organization such as CLEAR is going to get published it will be based on categories of scoliscore risk factors.

If we are able to stop progression in a high risk 1% group then we will know that those surgical cases are treatable. Scolioscores statistics are already pointing to bracing as ineffective at stopping the 1% high risk group.

The HUGE question is what do we do with the other 99% of kids who through natural course will not reach 50* but still have visible deformity at 30-49 degrees. This is where I believe CLEAR will fit in because we are starting to see sustained reductions in moderate risk kids.

Again premature to shout from the rooftops but time is the only thing that will prove or disprove my statement. It won't be about stopping progression but about non surgical reduction and stabilization.

[Pooka1]

Unfortunately most studies will be disregarded unless the genetic profile is included in the research.

The scoliosis community will play a tennis match back and forth with one group saying it works and the other saying it doesn't.

If an organization such as CLEAR is going to get published it will be based on categories of scoliscore risk factors.

Yes I completely agree but would broaden it to ALL conservative treatments, not just Clear. I think a lack of reference to the Scoliscore will make some papers unpublishable (or should). And unless they show the score is NOT <41 for all patient subjects, there can be no statement about a efficacy of a conservative treatment in the short term at least.

As for long term, we know it is not unusual (not necessarily common though) for curves >30* to progress to surgical range even as young adults per at least one surgeon. Further, there is some evidence for being <30* as protective against progression to surgical range but not necessarily protective against ancillary damage which might necessitate surgery due to pain and avoidance of further damage.

If we are able to stop progression in a high risk 1% group then we will know that those surgical cases are treatable. Scolioscores statistics are already pointing to bracing as ineffective at stopping the 1% high risk group.

Yes exactly. That is the acid test and the results will be hard to argue if the study is tight.

The HUGE question is what do we do with the other 99% of kids who through natural course will not reach 50* but still have visible deformity at 30-49 degrees. This is where I believe CLEAR will fit in because we are starting to see sustained reductions in moderate risk kids.

Yes this group is a huge open question and that doesn't look like it will get any clearer with Scoliscore. Another better genetic test will be needed.

Again premature to shout from the rooftops but time is the only thing that will prove or disprove my statement. It won't be about stopping progression but about non surgical reduction and stabilization.

The bottom line is avoiding surgery for most if not all folks. If a conservative approach can do that unambiguously for most/all patients then it should be Nobel fodder in my opinion. It's always dicey to say but enough about bracing is known now to suggest bracing will never be the answer for most kids due to the huge variability in my opinion. And compliance will always be an issue no matter what any study shows because it's just so hard and there are no guarantees about avoiding surgery with bracing.

The person who makes spinal fusion for scoliosis pain or progression obsolete should have the Nobel in my opinion.

[dovoranydoc]

The person who makes spinal fusion for scoliosis pain or progression obsolete should have the Nobel in my opinion.

That is the goal! Well said.

I believe the next decade will be a game changer for scoliosis patients and I truly hope to be part of the process, there are some wonderfully dedicated intelligent folks from different scientific communities working towards a better way.

[Pooka1]

Here's an other thread discussing Katz et al.

http://www.scoliosis.org/forum/showt...r-Dr.-McIntire

I am not a stats person but I think there might be some issue with needing one-tailed statistics since they are looking at progression whereas reduction is not really a factor in bracing. But I don't know enough about stats other than to suggest it might be relevant to the data crunching.

[skevimc]

Yes I completely agree but would broaden it to ALL conservative treatments, not just Clear. I think a lack of reference to the Scoliscore will make some papers unpublishable (or should).

While the scoliscore would be a great tool to confirm patients at med-high risk for progression and could greatly strengthen papers that showed positive results, I fear it could also unfairly discount other studies, i.e. small studies with smaller budgets. Maybe they'll give a research discount for the test. Otherwise, for any study to be published would require >$2 million just for genetic testing. ($2500/test - need ~ 100 patients to find the small percentage with a high score.) Or if there was a PCR kit available for those with a basic science lab. Then we could do our own test. Not for diagnostic purposes but for research/publication purposes. I think a gene array runs around $500 or so.

And unless they show the score is NOT <41 for all patient subjects, there can be no statement about a efficacy of a conservative treatment in the short term at least.

Perhaps not as it relates to avoiding surgery. But another aim of a study would be to reduce the curve. You all are already mentioning this, but if the scoliscore is cornering the market on who will need surgery and who won't, then another area of research begins to develop in order to improve/decrease the curve.

[Pooka1]

That's an excellent point about cost. But it doesn't obviate the situation now wherein ~75% of the patients will have a score <41. That is a huge KNOWN confounder in any study going forward and also informs us on the reliability of previous studies of bracing and such.

The point of permanently reducing curves is interesting but is only potentially limited to PT. Bracing is not known to permanently reduce curves and I just remembered the term for the statistics when you have a situation like that which I previously called one-tailed... I believe the correct term is left-censored data. It comes up in my field when dealing with data near the detection limit which of course is the textbook case of left-censored data I suppose.

[Pooka1]

That's an excellent point about cost. But it doesn't obviate the situation now wherein ~75% of the patients will have a score <41. That is a huge KNOWN confounder in any study going forward and also informs us on the reliability of previous studies of bracing and such.

By the way, this is consistent with the previous estimate that ~70% of kids who are braced are braced needlessly in the sense that they would not have progressed to surgery territory anyway. That was an extremely adept and astute observation to pull out of the ruins of that one bracing study where the L curves were stacked in the braced group and the T curves were stacked in the observation group, all inadvertently. To hit the number so closely, some folks are just good at what they do. It's a very good thing they are in research. Clever, clever.

[skevimc]

By the way, this is consistent with the previous estimate that ~70% of kids who are braced are braced needlessly in the sense that they would not have progressed to surgery territory anyway.

Avoiding surgery is certainly the biggest aim of treatment, it's not the only aim. So it might not be entirely accurate to say they were needlessly braced.

That was an extremely adept and astute observation to pull out of the ruins of that one bracing study where the L curves were stacked in the braced group and the T curves were stacked in the observation group, all inadvertently. To hit the number so closely, some folks are just good at what they do. It's a very good thing they are in research. Clever, clever.

This is an interesting statement you are making here. You're giving credit to researchers for pulling an observation out of flawed data but you criticize other groups who try to do the same thing and question their motives, e.g. Katz et al. Could it be that many researchers are good at what they do?

[Pooka1]

Avoiding surgery is certainly the biggest aim of treatment, it's not the only aim. So it might not be entirely accurate to say they were needlessly braced.

Well if some kids won't wear a brace even to avoid surgery then I suggest there are more who won't wear one for any reason. Also, bracing is not claimed to permanently reduce curves. Not sure that is what you are saying, though.

This is an interesting statement you are making here. You're giving credit to researchers for pulling an observation out of flawed data but you criticize other groups who try to do the same thing and question their motives, e.g. Katz et al. Could it be that many researchers are good at what they do?

No I believe the 70% figure was estimated by someone looking at others' flawed study and trying to salvage something, anything out of it rather than throw the entire thing out the window. That's my recollection of where that came from. He apparently did a very good job of it.

Katz et al. does not seem relevant to your point because it is their own data, they do not admit it is flawed, and they stand behind how they crunched it. I am saying that there are a few graphs they they could have shown that are pretty obvious in my opinion but which were not shown. They appeared to have sliced and diced the data into ever smaller bins until they hit on certain things, simultaneously driving up the variability. Does anyone really think there are step increases at 7 hours and 12 hours in the total data set? I think the data might generally trend but the scatter might overwhelm it making the data impossible to use for prediction in any individual case.

I'd like to see all 100 points plotted as follows:

1. increase in degree versus actual hours of wear for each individual patient
2. progression amount versus starting Cobb
3. L, T, double majors plotted separately
4. medians versus means
5. error bars and confidence limits on all graphs

Maybe the conclusions would be about the same and maybe they wouldn't be.