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The first ever DNM study the planet has seen

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  • Diane
    started a topic Tip The first ever DNM study the planet has seen

    The first ever DNM study the planet has seen

    Posted originally to one of those tedious Facebook threads where fascialists and non-fascialists try to knock each other out.
    Since DNM has been raised as a topic, and a call has been made for evidence, I would like to inform Flowers and others that, yes, DNM has been subjected to preliminary study. Full data was collected on four subjects. (Yes, I know, not very many.)

    We could have collected data for just 2 weeks, pre and post: two weeks is a standard for this A-B-A study design. But I objected - I thought 2 weeks didn't really say much at all about long term improvement from a treatment which included pain education and the manual part of which focused strictly on the nervous system as a continuously self-signalling entity from skin cell to sense of self. I wanted that pre-and post treatment phase to be as long as possible. We agreed to 8 weeks.

    Treatment period was 2 weeks, and contained three treatment sessions of an hour per except for the initial visit which was 90 minutes and included interview, assessment, pain ed. and some manual treatment.

    Subjects collected and submitted standardized pain score data for 8 weeks prior to to treatment phase and 8 weeks post. We started out with 7 subjects who met inclusion criteria, but 3 dropped out post treatment (we think they just got tired of collecting and submitting), so we chose not to include their data at all. Eight weeks was too long for them, probably.

    The data, once crunched into trend lines, showed decreasing pain in three subjects, while in the 4th, pain scores declined but went back up again post treatment.

    The data showed decreased variability in pain scoring. According to Dr. Susan Tupper at U Sask, whose PhD has to do with extracting pain information from juveniles with rheumatoid arthritis, decreased variability correlates strongly with "less suffering" from pain - if it becomes less unpredictable it becomes easier for people to manage.
    Overall the data showed "weak" (because the N was small) but "statistically significant" (take that however you like) support for the method. The study is ready to be written up and published somewhere. I plan to polish it up this winter. There has been no particular rush - the basic draft has been done and final writing will have to be as precise as possible which will mean many drafts, much word smithing etc.

    It's small, but it's solid, watertight, and it's a start.
    My opinion (FWIW) is that big isn't necessarily better. Furthermore, it isn't ever going to be possible for one's explanatory model to be completely "right" when treating something as nebulous as pain with something else as nebulous as manual therapy, but I think it IS important to continually strive to become ever "less wrong" by taking heed of the whole (i.e, neuroscience, not just tissue) and continually integrate it, so that manual therapy can eventually leave its ghetto existence by laying aside all explanatory models that are clunky, restrictive, and simply no longer fit modern 21st century concepts of full human organism function.

  • angaho
    replied
    Interesting thread. Good to see new people here.


    Sent from my iPad using Tapatalk. Welcome to www.sekito.se :-)

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  • John W
    replied
    At the risk of being perceived as moderating Diane's forum, I was specifically responding to the assertion that ABA designs are "pseudoscience". That's not true, and I would think that a biostatistician would know the difference between pseudoscience and lower levels of investigation that, although less rigorous than an RCT, have a legitimate place in the process of scientific discovery, particularly in the clinical sciences.

    Having said that, I'm very glad that you decided to return, hrishi, and I did not intend to come across as unwelcoming. I apologize for my curt response.

    Leave a comment:


  • rydog
    replied
    proving causality

    hrishi:

    That ABA tests can't prove causality is a fact. I can speak about that since I'm a biostatistician.
    Okay, so proving causality is a famous problem in inference. As a statistician you should appreciate that you're using the word prove with a different connotation than a mathematical proof. Nobody can prove that "X causes Y" at the level of rigor that one can prove the Pythagorean theorem.

    So, on a scale from 1 to 10, where 10 is a math-proof-inference and 1 is a random correlation, where is a perfectly executed double-blinded placebo drug trial? Where is a perfectly executed A-B-A trial?

    We need statistics that work for N=1 evidence. It's infeasible to do clinical trials at a whole-population scale, and it's unethical to forgo clinical trials and to do inference retrospectively, at the whole-population scale (which still may not be tractable).

    Or let's talk about your situation: you're an individual human, which means, among other things, that the material configuration of your organism is (overwhelmingly likely) to be unprecedented in history. Feeling better will require a series of events that are also unprecedented (as they include, at minimum, yourself). At some level of fuzziness, one can correlate your organism to the ones similar to yourself, but precisely delineating this boundary is just another flavor of the underlying inference problem. I can probably guess the number of vertebrae in your neck, but even that comes with an error bar.

    So when you say:
    I'm just a patient who's been suffering from neck pain from the past 2 years-initiated by a c56 extrusion.
    are you trying to distinguish the initiation of your pain from the cause of your pain? And how will we put an error bar on this statement?

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  • Bas Asselbergs
    replied
    Hi hrishi:
    How would you be able to differentiate placebo from the actual effect of DNM in an ABA test? I appreciate the difficulty in conducting a sham "DNM" intervention but that does not mean that an ABA test is "acceptable" evidence and an RCT is not needed.
    An important point is: what is "acceptable"?
    In many of the discussions here, evidence is the centre.
    A case history is acceptable evidence that something has been observed and is of interest.
    RCTs are impossible to design for manual interventions of the gentle kind - especially where the method involved is intricately mixed with verbal education and verbal instruction about interoception....
    @the community: if you folks feel I should not post here I'm fine with that-no intention to intrude.
    Please! I do not see this as an intrusion at all! We can certainly use input/questions/debates from any informed source - and a biostatistician brings a whole load of knowledge that I sorely lack....

    Leave a comment:


  • Barrett Dorko
    replied
    Diane says:

    By the way, DNM is not a "thing" and there are no "experts".
    I agree entirely, but we can't expect others to understand that. We have been forced to come from a different direction. Tomorrow's blog will address that. I think.

    Leave a comment:


  • Diane
    replied
    Hi hrishi, welcome back.
    I know all that.
    In manual therapy there is never any chance that correlation will ever come close enough to be considered causation no matter how fancy the testing or how randomized the control because of the impossibility of providing sham.

    See the interview with Nicolai Bogduk for more about the inherent difficulties in researching physical medicine.

    This study was a pilot study, sort of. It never got off the ground. The design was way too awkward and the obstacles insurmountable. It was basically a still-born that took years to evacuate itself. It's over. I'm never going to bother with anything so exhausting and ridiculous ever again.

    By the way, DNM is not a "thing" and there are no "experts".
    Last edited by Diane; 28-11-2015, 03:36 PM.

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  • hrishikeshvganu
    replied
    Well I see there's been a flurry of posts following my last post here. I'm not a PT/clinician but by way of introduction I'm just a patient who's been suffering from neck pain from the past 2 years-initiated by a c56 extrusion.
    I did not mean to ( and neither does my post "read" so) be disrespectful to Diane/to the community here. That ABA tests can't prove causality is a fact. I can speak about that since I'm a biostatistician.

    How would you be able to differentiate placebo from the actual effect of DNM in an ABA test? I appreciate the difficulty in conducting a sham "DNM" intervention but that does not mean that an ABA test is "acceptable" evidence and an RCT is not needed.

    "How to conduct a sham intervention" is something for the DNM experts here to think through. To start with the trial could be no-intervention vs DNM so that we can atleast prove that Placebo+DNM is better than no-intervention. This should be easier to conduct I assume?

    @the community: if you folks feel I should not post here I'm fine with that-no intention to intrude.

    Leave a comment:


  • Jo Bowyer
    replied
    Originally posted by Diane View Post
    I suspect that group was trying to show that getting cavitation was something and the "sham" wasn't.
    Whatever, both groups were getting DNM.
    Cavitation/Schmavitation. It's a party trick. This is what I took from reading the paper.

    Randomized controlled trials (RCTs) are regarded as the gold standard in clinical research. Most pharmacological RCTs are double-blinded and include placebos. However, it is impossible to conduct a double-blinded manual-therapy RCT because the person who applies the intervention is clearly un-blinded. Thus, the question that arises, is whether it is possible to include a placebo arm in a manual-therapy RCT?
    Consequently, the question remains as to whether it is possible to provide placebo intervention and maintain the blinding during the course of a typical manual-therapy treatment period, as well as question of how confident the participants are that they have had active treatment.
    Randomization
    Prepared numbered sealed lots with the two interventions, active and placebo intervention were subdivided into four subgroups by age and gender, i.e., 18–39 and 40–70 years of age and men and women, respectively. The participants drew one lot that allocated them to either the active or the placebo treatment. The blocked randomization procedure minimizes the risk of selection bias and was administered exclusively by an external party without the involvement of the clinical investigator (AC).
    Statistical analysis
    The dichotomous “yes” and “no” data were presented as percentages with 95% confidence intervals (CI), whereas the continuous 0–10 NRS outcome were presented as the means with 95% CI for each treatment group, i.e., CSMT and placebo.
    it is possible to include a valid placebo group, considering that we demonstrated successful blinding during 12 treatment sessions over three months in both active and placebo groups.
    I am not a researcher and have no plans to jump through the hoops in order to become one. However, I enjoy being a number in the trial I'm in as a patient and am happy to rock up and look at stuff as a clinician in other people's trials. It's the best I can do. There are researchers out there gagging for ideas and those of us at the coal face may be in a position to provide them.

    I like reading meta-analyses and hope that one day something I have been part of (of which I have been a part ) , will feature in one.
    Last edited by Jo Bowyer; 23-11-2015, 09:54 AM.

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  • Diane
    replied
    Originally posted by Jo Bowyer View Post
    http://www.nature.com/articles/srep11774

    Abstract


    This group appear to have made a start on the problem
    I suspect that group was trying to show that getting cavitation was something and the "sham" wasn't.
    Whatever, both groups were getting DNM.

    Leave a comment:


  • Diane
    replied
    Originally posted by John W View Post
    On what planet is an ABA test pseudoscience? That's an ignorant- and harsh- statement. I don't care how many times you've posted here.

    I'm not sorry either.


    Sent from my iPhone using Tapatalk
    Hi John,
    I can moderate my own forum.
    Thanks.

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  • John W
    replied
    On what planet is an ABA test pseudoscience? That's an ignorant- and harsh- statement. I don't care how many times you've posted here.

    I'm not sorry either.


    Sent from my iPhone using Tapatalk

    Leave a comment:


  • Jo Bowyer
    replied
    Validation of Placebo in a Manual Therapy Randomized Controlled Trial

    http://www.nature.com/articles/srep11774

    Abstract
    At present, no consensus exists among clinical and academic experts regarding an appropriate placebo for randomized controlled trials (RCTs) of spinal manipulative therapy (SMT). Therefore, we investigated whether it was possible to conduct a chiropractic manual-therapy RCT with placebo. Seventy migraineurs were randomized to a single-blinded placebo-controlled clinical trial that consisted of 12 treatment sessions over 3 months. The participants were randomized to chiropractic SMT or placebo (sham manipulation). After each session, the participants were surveyed on whether they thought they had undergone active treatment (“yes” or “no”) and how strongly they believed that active treatment was received (numeric rating scale 0–10). The outcome measures included the rate of successful blinding and the certitude of the participants’ beliefs in both treatment groups. At each treatment session, more than 80% of the participants believed that they had undergone active treatment, regardless of group allocation. The odds ratio for believing that active treatment was received was >10 for all treatment sessions in both groups (all p < 0.001). The blinding was maintained throughout the RCT. Our results strongly demonstrate that it is possible to conduct a single-blinded manual-therapy RCT with placebo and to maintain the blinding throughout 12 treatment sessions given over 3 months.
    This group appear to have made a start on the problem

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  • Diane
    replied
    Originally posted by Barrett Dorko View Post
    "Subjected to this"?

    It's time to be the way we are.
    You can be however you want or are in your forum.

    Leave a comment:


  • Diane
    replied
    Originally posted by Barrett Dorko View Post
    "Subjected to this"?

    It's time to be the way we are.
    Ahem, it's my thread, in my forum.

    Leave a comment:

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