OMT and "Late-Pregnancy Back Pain"

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JaggerPlate

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Don't know if anybody saw, but TCOM/UTSH just completed and published a study concerning OMT and lower-back pain in 30+ week pregnant women. Pretty cool results. Here's the excerpt from the AOA (John Crosby ... http://blogs.do-online.org/dailyreport.php):

New Evidence for OMT Efficacy

February 09, 2010 The Osteopathic Research Center (ORC) at the University of North Texas Health Science Center has released results from its study on using OMT to treat pregnant women who have low back pain. AOA member John C. Licciardone, DO, executive director of the ORC, served as lead author of the study, which found that OMT can be a viable option for improving function related to the low back and reducing back pain in the third trimester of pregnancy. The study was recently published in the American Journal of Obstetrics and Gynecology, adding to the evidence base for the efficacy of OMT. In addition, several news organizations, including Medical News Today, ran announcements of the study and its findings. Read the Medical News Today story online.

OMT Study Gains More Media Attention

The Osteopathic Research Center's (ORC) study on using OMT to treat pregnant women's back pain continues to earn widespread media attention. Yahoo.com published a story on 2/10/10 regarding the study's finding that "gentle manipulation from an osteopathic doctor may relieve late-pregnancy back pain," quoting several DOs on the many benefits of OMT. Reuters ran a similar story on 2/10/10 regarding the study, which was initially published in the American Journal of Obstetrics and Gynecology. Several pregnancy-focused Web sites and blogs also published the story to educate pregnant women about their non-pharmaceutical pain treatment options. Read more online.

Essentially ... in a study with 3 groups - preggos receiving normal OB care once a week, women receiving OB care + OMM once a week, and women receiving OB care + fake treatment once a week, women in the OMM group reported reduced back pain. More to come, and nothing too crazy, but a cool study that was also published in the American Journal of OB/GYN.

Here are some interesting links:
http://news.yahoo.com/s/nm/20100210/hl_nm/us_osteopathic_care

http://www.reuters.com/article/idUSTRE6194WJ20100210

http://rxhollywood.wordpress.com/2010/02/18/osteopathic-manipulation-and-pregnancy-related-pain/

http://www.ajog.org/

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Why didn't they include another modality where people lay hands on the participants? The fake treatment they used was ultrasound. They should have done somthing like massage since it would better approximate OMM without actually doing OMM. Then you would know it was the actual manipulation. They probably would have still found the difference and it would have made the study a lot stronger.
 
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Why didn't they include another modality where people lay hands on the participants? The fake treatment they used was ultrasound. They should have done somthing like massage since it would better approximate OMM without actually doing OMM. Then you would know it was the actual manipulation. They probably would have still found the difference and it would have made the study a lot stronger.

:thumbdown:
Maybe you should contact these attending physicians and impart your amazing MD student wisdom.
 
I am by no means an OMM expert but the nurses at work love it! they can't take anything and don't want to miss work so they just suck it up all day. did it work, placebo or it got them to lay down/away from pts for 10 min? probably all of the above....either way happy nurses = happy shift
 
Why didn't they include another modality where people lay hands on the participants? The fake treatment they used was ultrasound. They should have done somthing like massage since it would better approximate OMM without actually doing OMM. Then you would know it was the actual manipulation. They probably would have still found the difference and it would have made the study a lot stronger.

Something like massage may have its own benefits as well. Then how to tease apart the effect of getting a massage vs. OMT? My guess is (without reading the article yet) that these guys knew their controls were going to be the weak link and did the best they could given their limitations.
 
Why didn't they include another modality where people lay hands on the participants? The fake treatment they used was ultrasound. They should have done somthing like massage since it would better approximate OMM without actually doing OMM. Then you would know it was the actual manipulation. They probably would have still found the difference and it would have made the study a lot stronger.

I read a study one time where they were trying to do a real vs sham OMM treatment, and some of the researchers determined you could actually do harm/mess stuff up with a believable sham OMM treatment, which would obviously goof up the study and really give biased results.
 
You have to take this with a grain of salt. It was a small study; 144 patients. These patients were young, it started in the 28-30th week and it excluded high risk patients, as defined by their OBs, which is vague. The definition of standard obstetrical care was vague and no specific technique was mentioned. This was also not mentioned to be double blinded. Overall this is a less than convincing article.
 
You have to take this with a grain of salt. It was a small study; 144 patients. These patients were young, it started in the 28-30th week and it excluded high risk patients, as defined by their OBs, which is vague. The definition of standard obstetrical care was vague and no specific technique was mentioned. This was also not mentioned to be double blinded. Overall this is a less than convincing article.

Well I mean, OMT or manual therapy for that matter, is a tricky subject to research in general. The study said it should be repeated with a larger sample size, but to be fair, finding 144 healthy, willing women, between 28-30 weeks of pregnancy in one limited geographical area is no small accomplishment in my opinion. Also, the average age was young, and I guess high risk is vague (keep in mind this article was published in the American Journal of OB/GYN, so their target audience probably has a pretty good idea of what this generally entails), but they probably wanted to avoid other health issues affecting the study and didn't want anyone already compromised because lets face it ... it's still research, and the consequences for realizing OMM is bad for pain or harmful, etc, are pretty severe. Again with the standard OB thing being vague, my guess is that the OBs reading the article know what's up, or that it is just pretty standard stuff. Furthermore ... I thought the test groups were pretty well set up and defined, but I'm not sure how you could ever have a double blind study concerning OMM, IF you are referring to both the doctor and patient not knowing what treatment was being given???? Probably not great for research snobs, but I thought it was cool to see some decent research done on this subject, and presented in a respectable journal (from what I can tell).
 
Well I mean, OMT or manual therapy for that matter, is a tricky subject to research in general. The study said it should be repeated with a larger sample size, but to be fair, finding 144 healthy, willing women, between 28-30 weeks of pregnancy in one limited geographical area is no small accomplishment in my opinion. ... Probably not great for research snobs, but I thought it was cool to see some decent research done on this subject, and presented in a respectable journal (from what I can tell).

The problem for me is that OMM research has faced these problems before. It needs to begin addressing these issues at some point.

Frankly, I'm not totally sold on OMM. I don't consider myself a research snob either. While I'm encouraged by the papers I've seen on OMM, I'm already wishing that I could see some more study into how it actually works, or how OMM performs past the case study level. I understand that DOs as a whole are only taking their first steps (relatively) towards research and that it will take time. It is, in my eyes, a step that could be worth taking.

That said, from what I've heard, OMM recipients seem to love it. Even if the therapeutic benefit is small, if it's another tool - especially a non-chemical, non-invasive tool with little in the way of side effects - I'm game for using it. There's just more I want to understand about it. We'll see what the future brings.
 
With regard to how tightly we can control research, a professor in the department my MS will come from presented me with this little nugget:
We can either have science that is very clean but not very relevant, or science that is exceptionally relevant but not very clean.

It's tough to tease apart confounding effects without removing the context of the matter being studied. It is an ever present problem in science and OMT happens to be in a precarious situation with regard to this.
 
Well I mean, OMT or manual therapy for that matter, is a tricky subject to research in general. The study said it should be repeated with a larger sample size, but to be fair, finding 144 healthy, willing women, between 28-30 weeks of pregnancy in one limited geographical area is no small accomplishment in my opinion. Also, the average age was young, and I guess high risk is vague (keep in mind this article was published in the American Journal of OB/GYN, so their target audience probably has a pretty good idea of what this generally entails), but they probably wanted to avoid other health issues affecting the study and didn't want anyone already compromised because lets face it ... it's still research, and the consequences for realizing OMM is bad for pain or harmful, etc, are pretty severe. Again with the standard OB thing being vague, my guess is that the OBs reading the article know what's up, or that it is just pretty standard stuff. Furthermore ... I thought the test groups were pretty well set up and defined, but I'm not sure how you could ever have a double blind study concerning OMM, IF you are referring to both the doctor and patient not knowing what treatment was being given???? Probably not great for research snobs, but I thought it was cool to see some decent research done on this subject, and presented in a respectable journal (from what I can tell).

That always seems to be the problem giving "sham OMT". I would love to see an expanded study on this. My one concern is whether OMT might be dangerous to the fetus. With such a small grouping it is difficult to tell. My problem with the definition of high risk is do you mean pre-eclampsia or are active HSV infections considered high-risk? Is age a risk factor? Also how severe was the back pain? Also there may have been selection bias i.e. seeing an osteopathic OB.
 
With regard to how tightly we can control research, a professor in the department my MS will come from presented me with this little nugget:
We can either have science that is very clean but not very relevant, or science that is exceptionally relevant but not very clean.

It's tough to tease apart confounding effects without removing the context of the matter being studied. It is an ever present problem in science and OMT happens to be in a precarious situation with regard to this.

Yeah. Doesn't keep me from wishing though.
 
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That always seems to be the problem giving "sham OMT". I would love to see an expanded study on this. My one concern is whether OMT might be dangerous to the fetus. With such a small grouping it is difficult to tell. My problem with the definition of high risk is do you mean pre-eclampsia or are active HSV infections considered high-risk? Is age a risk factor? Also how severe was the back pain? Also there may have been selection bias i.e. seeing an osteopathic OB.
As a freshman in college, where are all these thought processes come from?
 
As a freshman in college, where are all these thought processes come from?

By virtue of being well read. The study while interesting seems to give rise to more questions than it answers.
 
As a freshman in college, where are all these thought processes come from?

He/she is very well versed in health related topics, specifically research ... hence the BS/DO.
 
That always seems to be the problem giving "sham OMT". I would love to see an expanded study on this. My one concern is whether OMT might be dangerous to the fetus. With such a small grouping it is difficult to tell. My problem with the definition of high risk is do you mean pre-eclampsia or are active HSV infections considered high-risk? Is age a risk factor? Also how severe was the back pain? Also there may have been selection bias i.e. seeing an osteopathic OB.

I think pre-eclampsia or something in vein, I'm not sure how much viral infections would come into play. As far as dangerous to the fetus ... I'm not well versed enough in OMM, but from what I've seen, it doesn't seem overtly likely. I find it even less likely that if this was a factor, more OBs wouldn't be opposed to it, and it would receive this type of research or publication. There are definitely some questions, but frankly, I don't think I've ever read an article that didn't leave several open ends and questions unanswered. It's the nature of the beast in my opinion and probably will lead to more extensive research .. ie, okay we believe it to be beneficial, now, lets see how it differs with age, who it is/is not for (ie pre-eclampsia patients, immuno compromised, etc).
 
He/she is very well versed in health related topics, specifically research ... hence the BS/DO.

I'm a he LOL. BTW JaggerPlate, I was disappointed to hear you weren't coming to NSU-COM. I love health care research and am well versed on the academic end in some small areas of it. Right now I'm working on a novel drug delivery system here at NSU. With some luck you should see a journal entry in the next 1.5-2 years.
 
I think pre-eclampsia or something in vein, I'm not sure how much viral infections would come into play. As far as dangerous to the fetus ... I'm not well versed enough in OMM, but from what I've seen, it doesn't seem overtly likely. I find it even less likely that if this was a factor, more OBs wouldn't be opposed to it, and it would receive this type of research or publication. There are definitely some questions, but frankly, I don't think I've ever read an article that didn't leave several open ends and questions unanswered. It's the nature of the beast in my opinion and probably will lead to more extensive research .. ie, okay we believe it to be beneficial, now, lets see how it differs with age, who it is/is not for (ie pre-eclampsia patients, immuno compromised, etc).

The viral infection example was merely to illustrate something that could be considered high risk in terms of OB and the ambiguity of the term. I would be particularly interested to know what the average weight, height etc. with SDs was for the patients. Would these results be applicable to obese or older mothers who seem to be making up an ever larger percentage of the population of pregnancies? I really want to see the data behind this as it seems more promising and interesting than the analysis does.
 
The problem for me is that OMM research has faced these problems before. It needs to begin addressing these issues at some point.

Frankly, I'm not totally sold on OMM. I don't consider myself a research snob either. While I'm encouraged by the papers I've seen on OMM, I'm already wishing that I could see some more study into how it actually works, or how OMM performs past the case study level. I understand that DOs as a whole are only taking their first steps (relatively) towards research and that it will take time. It is, in my eyes, a step that could be worth taking.

That said, from what I've heard, OMM recipients seem to love it. Even if the therapeutic benefit is small, if it's another tool - especially a non-chemical, non-invasive tool with little in the way of side effects - I'm game for using it. There's just more I want to understand about it. We'll see what the future brings.

I agree, but I also see the challenges it faces. To me, it's fantastic, and does help patients, and that is important. Also, there are quite a few therapies out there that are readily used, and we just don't know hot they work. Did you know we still don't know how Minoxidil, the key compound in Rogaine, actually aids in stopping hair loss? Huge, used every day, recommended by everyone, and shows significant results, but although it started as a trial drug for renal failure, we still just don't know the mechanism in which it stops hair loss??? So, you can always rely on that argument, however ...

I don't like it. I'd prefer things that both help patients and are understood. The problem is that OMT is really kind of hard to research. Like FutureCT brought up ... how can you do a double blind study with respect to both doctor and patient being unaware??? It's nearly impossible. How do you test something across the board when each practitioner is slightly different?? Etc. HOWEVER, there are decent studies with OMM that don't depend on this mentality and say okay this thing works for patients, but how. A few interesting ones ...

Nitric oxide as a possible mechanism for understanding the therapeutic effects of osteopathic manipulative medicine (Review).

Salamon E, Zhu W, Stefano GB.

Neuroscience Research Institute, State University of New York, College at Old Westbury, Old Westbury, NY 11568, USA.

Throughout the history of medicine we have seen the progression of medical therapies from the empirical to the counter-intuitive, with much pressure being placed upon the scientific community to distinguish the two. This exercise has proven the effectiveness of numerous modern therapeutic techniques that have been adapted into modern medicine with remarkable success. While it is certain that many of these techniques yield beneficial results, the mechanisms by which these results are achieved have not been fully realized. In the present report, we consider the case of osteopathic manipulative medicine (OMM), which represents a therapeutic technique developed over a century ago as a means of non-invasive treatment for numerous ailments. Our intention is to use current findings from our laboratory, as well as those of our colleagues in the area of nitric oxide (NO) research to explain the mechanism through which osteopathic manipulations aid the patient. These reports demonstrate that fluidic motions applied to vascular and nerve tissue in a manner comparable to manipulations can cause a remarkable increase in NO concentration within the blood and vasculature. These findings combined with the overwhelming amount of research into the beneficial effects of constitutive NO provide a dynamic theoretical framework to explain the therapeutic effects of OMM.

or people who want to look at other methods and work off research like this (article posted from a SDN member interested)


Mechanisms of endocannabinoid inactivation: biochemistry and pharmacology.

Link to full article

Giuffrida A, Beltramo M, Piomelli D.

Department of Pharmacology, University of California, Irvine, California 92697-4625, USA. [email protected]

The endocannabinoids, a family of endogenous lipids that activate cannabinoid receptors, are released from cells in a stimulus-dependent manner by cleavage of membrane lipid precursors. After release, the endocannabinoids are rapidly deactivated by uptake into cells and enzymatic hydrolysis. Endocannabinoid reuptake occurs via a carrier-mediated mechanism, which has not yet been molecularly characterized. Endocannabinoid reuptake has been demonstrated in discrete brain regions and in various tissues and cells throughout the body. Inhibitors of endocannabinoid reuptake include N-(4-hydroxyphenyl)-arachidonylamide (AM404), which blocks transport with IC50 (concentration necessary to produce half-maximal inhibition) values in the low micromolar range. AM404 does not directly activate cannabinoid receptors or display cannabimimetic activity in vivo. Nevertheless, AM404 increases circulating anandamide levels and inhibits motor activity, an effect that is prevented by the CB1 cannabinoid antagonist N-(piperidin-1-yl)-5-(4-chlorophenyl)-1-(2,4-dichlorophenyl)-4-methyl-1H-pyrazole-3-carboxamide hydrochloride (SR141716A). AM404 also reduces behavioral responses to dopamine agonists and normalizes motor activity in a rat model of attention deficit hyperactivity disorder. The endocannabinoids are hydrolyzed by an intracellular membrane-bound enzyme, termed anandamide amidohydrolase (AAH), which has been molecularly cloned. Several fatty acid sulfonyl fluorides inhibit AAH activity irreversibly with IC50 values in the low nanomolar range and protect anandamide from deactivation in vivo. alpha-Keto-oxazolopyridines inhibit AAH activity with high potency (IC50 values in the low picomolar range). A more thorough characterization of the roles of endocannabinoids in health and disease will be necessary to define the significance of endocannabinoid inactivation mechanisms as targets for therapeutic drugs.


This is the kind of research that goes beyond 'it works' and starts to look at how/why it works. It's out there, just not seen that much.

** note on that second article ... I know it's not really about OMT, but Drusso, an ex OMM fellow and PM&R doc posted it in Osteo awhile ago because of the potential for it's connection with OMM ... here is what he said about it:

The analgesic and psychotropic effects of physical modalities such as OMT may be grounded in the modulation of the body's various stress hormones. Recent developments in this area of research include identifying and measuring various biomarkers such as inflammatory markers, nitric oxide, endorphins, and perhaps even more promising, various endocannabinoids before and after the application of physical treatments such as OMT. This month's series of articles will overview the pharmacology of the endocannabinoids and their potential impact on future OMT research.
 
I'm a he LOL. BTW JaggerPlate, I was disappointed to hear you weren't coming to NSU-COM.

It was a tough decision. NSU was always one of my top choices, and I loved the program ... KCOM just barely inched out in the end. It came down between CCOM, NSU, and KCOM, and sending my letter that I wasn't attending NSU was horrible! I was seriously like sad and doubted what I did the whole day, hahaha.
 
I'm a he LOL. BTW JaggerPlate, I was disappointed to hear you weren't coming to NSU-COM. I love health care research and am well versed on the academic end in some small areas of it. Right now I'm working on a novel drug delivery system here at NSU. With some luck you should see a journal entry in the next 1.5-2 years.

JaggerPlate, I was dissapointed to hear that you weren't coming to LECOM-B!!!:mad:
 
JaggerPlate, I was dissapointed to hear that you weren't coming to LECOM-B!!!:mad:

Hahaha, that was another one I really liked!

I'll hang out with all of you though if you want ... ;)
 
This is an exciting article and I am happy to see it getting some publicity. People are always wanting research in the area, so a big article like this is good to see.

You have to take this with a grain of salt. It was a small study; 144 patients. These patients were young, it started in the 28-30th week and it excluded high risk patients, as defined by their OBs, which is vague. The definition of standard obstetrical care was vague and no specific technique was mentioned. This was also not mentioned to be double blinded. Overall this is a less than convincing article.

Couple points....1) In terms of the study size, 144 isn't a bad number at all. Remember, you are dealing with OMM, not medications or the like. So you are dealing with an extremely small number of physicians who are qualified to perform this procedure. Also, even though ever DO is qualified to perform this treatment, only a small number use it in practice, so that number is even smaller. Also, taking into the account of the geographic area, like JP said, I think overall the numbers are good. Yes, a larger study would be nice in the future, but this is a great start. 2) With the age, most OB pts are young, between 15-30. Outside that range of ages, you start becoming a higher risk, especially after 35. 3) High-risk pts will include those with pre-eclampsia, increased age, multiple gestations (esp. triplets or more), drug/alcohol use, previous history of complicated pregancy, etc. 4) As another poster said, doing a double-blind study with OMT is pretty difficult.

That always seems to be the problem giving "sham OMT". I would love to see an expanded study on this. My one concern is whether OMT might be dangerous to the fetus. With such a small grouping it is difficult to tell. My problem with the definition of high risk is do you mean pre-eclampsia or are active HSV infections considered high-risk? Is age a risk factor? Also how severe was the back pain? Also there may have been selection bias i.e. seeing an osteopathic OB.

OMT is not dangerous to the fetus. One would not do HVLA (racking and cracking) but rather gentler techniques.
 
This is an exciting article and I am happy to see it getting some publicity. People are always wanting research in the area, so a big article like this is good to see.



Couple points....1) In terms of the study size, 144 isn't a bad number at all. Remember, you are dealing with OMM, not medications or the like. So you are dealing with an extremely small number of physicians who are qualified to perform this procedure. Also, even though ever DO is qualified to perform this treatment, only a small number use it in practice, so that number is even smaller. Also, taking into the account of the geographic area, like JP said, I think overall the numbers are good. Yes, a larger study would be nice in the future, but this is a great start. 2) With the age, most OB pts are young, between 15-30. Outside that range of ages, you start becoming a higher risk, especially after 35. 3) High-risk pts will include those with pre-eclampsia, increased age, multiple gestations (esp. triplets or more), drug/alcohol use, previous history of complicated pregancy, etc. 4) As another poster said, doing a double-blind study with OMT is pretty difficult.



OMT is not dangerous to the fetus. One would not do HVLA (racking and cracking) but rather gentler techniques.

1) 144 is a very small study irrespective. There are certainly enough to do more than 144 OMT cases. I don't see why this number should be lower if this isn't a medication it is another treatment modality and should receive equally rigorous testing.

2) There is an increasing number of patients over the age of 30 in OB. This is an area that was not mentioned or dealt with.

3) High risk patients is an ill defined category and there was no listing of what was considered exclusionary criteria. Again what is high risk? It's in the eye of the provider. Two OBs may disagree on whether any specific case is high risk.

4) I will never be fully convinced until there is double blind studies as that is still the standard. This study while interesting is less than convincing.

OMT has not been established to be safe to the fetus and until proven safe it should not be assumed to be.
 
OMT has not been established to be safe to the fetus and until proven safe it should not be assumed to be.

You do know that medicine usually works the opposite way, right? If it seems safe and shows positive outcomes, it will be used until proven harmful.

Also, I'm sure the study is probably using "ACOGs" version of "high-risk pregnancy" and the like. Your HSV comment was a little out in left field.
 
You do know that medicine usually works the opposite way, right? If it seems safe and shows positive outcomes, it will be used until proven harmful.

Also, I'm sure the study is probably using "ACOGs" version of "high-risk pregnancy" and the like. Your HSV comment was a little out in left field.

You do recognize that this wasn't a really rigorous study. It wasn't even really single blind, patients can tell the difference between ultrasound and OMT. My comment regarding HSV is that could be defined as a high risk pregnancy. The baby needs to be delivered via C-section and neonatal herpes is potentially deadly. That was meant to illustrate that all sorts of things can make for a high risk pregnancy/delivery. Safety is usually more rigorous than comparing a tiny group like this.
 
Maybe TCOM should be closed for putting out such a bad study, or hire freshmen to design their studies.

Well, this was posted in pre-osteopathic, so I feel I can comment. TCOM should not be publishing studies that are so poorly designed. With so many biases it's no wonder OMT was effective. There might be a pro-OMT bias by virtue of seeing an osteopathic OB-GYN. There is also a flaw in using such a small number of patients, who aren't inherently representative of the whole pregnant population.
 
"I don't wanna do OMM, it's not evidence based ... research it. Oh ... I don't like the research.'


CT ...


1. How can it ever be double blind (w respect to both doctor and patient not knowing)??? Until we invent one of those little memory erasing devices ala Men in Black, the best study possible with manual therapies is single blind.

2. I'm not convinced women would be certain the ultra sound wasn't some sort of osteoopathic treatment, nor do I think this affects the study.

3. Again, like nascar was saying, this isn't a huge trial with something as simple as getting a general subject group and administering meds and placebos. You need healthy, pregnant individuals, between 28-30 weeks, who are willing and located within a limited geographical area. 144 is actually quite impressive.

4 I get you were just using HSV as an example (don't know why so much emphasis is being put on that one statement), but again, this publication was from AJOBGYN ... for all we know there could have been criteria which defined 'high risk' or this could be a common phrase in OB, and the authors didn't find it necessary to elaborate. It would be like writing an article about DNA in a genetics journal and taking the time to explain what a Nucleotide is (again, simply an example ... much like the HSV comment).

5. Remember that although standards, with regards to research, are a good, necessary thing, not all studies are created equal and ALL studies have flaws (I wrote a paper on an article yesterday which created far more questions than it answered, and was still recommended by the professor). It's a good, little study. These docs/researchers weren't looking for the Noble prize here, and they were testing something which was already pretty widely accepted and used.
 
Also with regards to fetal damage...there is a lateral recombinant position for OMM that was designed to treat patients that can't receive treatment in other positions. One of these conditions is pregnancy.
 
Well, this was posted in pre-osteopathic, so I feel I can comment. TCOM should not be publishing studies that are so poorly designed. With so many biases it's no wonder OMT was effective. There might be a pro-OMT bias by virtue of seeing an osteopathic OB-GYN. There is also a flaw in using such a small number of patients, who aren't inherently representative of the whole pregnant population.

I'm sorry you feel this is poorly designed. In today's world, a fairly cynical place, what makes you think placebo effects are inherently going to drive people into false positive results and not false negatives?

Have you done any sort of research that involved performing a medical procedure on someone? You are overly critical of n=144, yes it is a small number of patients, but treating each with OMT over time and following through is very time intensive. I think nascar made a great point, it isn't medication.

How much research have you actually done? More often then not alot of peer reviewed journal articles have major flaws or have the feeling of "this doesn't seem quite finished". Studies are not meant to be the end all be all, they are meant to put the information out there so others may either build upon the same research or dispute it with conflicting research until enough studies have been performed to sway public (professional) opinions one way or another.

If someone waited for a double-blind study, of n=>50k, controlling all possible variables and accounting for any and all side-effects, etc., etc. Then nothing would ever get published and medicine/technology would never move forward.
 
Studies are not meant to be the end all be all, they are meant to put the information out there so others may either build upon the same research or dispute it with conflicting research until enough studies have been performed to sway public (proffesional) opinions one way or another.

Yup. Don't think I've ever read a study which didn't say something about repeating with larger numbers, different variables, etc, at the end.
 
My comment regarding HSV is that could be defined as a high risk pregnancy. The baby needs to be delivered via C-section and neonatal herpes is potentially deadly. That was meant to illustrate that all sorts of things can make for a high risk pregnancy/delivery. Safety is usually more rigorous than comparing a tiny group like this.

Actually OBs do pretty much agree on what is considered high risk, and nascardoc nailed it. Just fyi, in a patient with recurrent HSV2 infections, prophylactic c-section is not indicated. The only time it is recommended is if the patient has active lesions at the time of labor or is having prodromal symptoms at this time. Most OBs recommend antiviral therapy starting at the 35th or 36th week in patients who have outbreaks monthly or bimonthly. Otherwise if they just have a +history, it's watchful waiting with a vaginal delivery preferred barring any other complications. The fact that the authors didn't define "high risk" is the least of the problems with the study. I can always find ways to rip apart a study and find things wrong with it, even the super duper double decker blind placebos with cherries on top.
 
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1. How can it ever be double blind (w respect to both doctor and patient not knowing)??? Until we invent one of those little memory erasing devices ala Men in Black, the best study possible with manual therapies is single blind.

2. I'm not convinced women would be certain the ultra sound wasn't some sort of osteoopathic treatment, nor do I think this affects the study.

JP made some great points here -

1. Totally true. Think about what double blind would mean in this situation. I can't even think of a way it would be possible and safe. I can think of unsafe ways - show someone like me who's never done it how to do OMM once. Then let me try. I don't know if I did it right or not, so someone watches me on video camera. If I did it right, it counts as receiving treatment. If I did it wrong, it's placebo. Then of course you'd have to have instant results, because a person who doesn't know what they're doing won't do it right the next time, so each time point would have to be independently evaluated. That would be a mess, and unsafe.

2. Notice there did appear to be a placebo effect in the sham ultrasound group. Also notice it was sham ultrasound. While using some sort of hands-on therapy may have been a better control, this is a truer placebo, as it's actually doing nothing. Massage probably has its own benefits, hence it would become a study of massage (or any other physical contact) vs. OMM.
 
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