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  • #31
    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
    Jo Bowyer
    Chartered Physiotherapist Registered Osteopath.
    "Out beyond ideas of wrongdoing and rightdoing,there is a field. I'll meet you there." Rumi

    Comment


    • #32
      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
      John Ware, PT
      Fellow of the American Academy of Orthopedic Manual Physical Therapists
      "Nothing can bring a man peace but the triumph of principles." -R.W. Emerson
      “If names be not correct, language is not in accordance with the truth of things. If language be not in accordance with the truth of things, affairs cannot
      be carried on to success.” -The Analects of Confucius, Book 13, Verse 3

      Comment


      • #33
        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.
        Diane
        www.dermoneuromodulation.com
        SensibleSolutionsPhysiotherapy
        HumanAntiGravitySuit blog
        Neurotonics PT Teamblog
        Canadian Physiotherapy Pain Science Division (Archived newsletters, paincasts)
        Canadian Physiotherapy Association Pain Science Division Facebook page
        @PainPhysiosCan
        WCPT PhysiotherapyPainNetwork on Facebook
        @WCPTPTPN
        Neuroscience and Pain Science for Manual PTs Facebook page

        @dfjpt
        SomaSimple on Facebook
        @somasimple

        "Rene Descartes was very very smart, but as it turned out, he was wrong." ~Lorimer Moseley

        “Comment is free, but the facts are sacred.” ~Charles Prestwich Scott, nephew of founder and editor (1872-1929) of The Guardian , in a 1921 Centenary editorial

        “If you make people think they're thinking, they'll love you, but if you really make them think, they'll hate you." ~Don Marquis

        "In times of change, learners inherit the earth, while the learned find themselves beautifully equipped to deal with a world that no longer exists" ~Roland Barth

        "Doubt is not a pleasant mental state, but certainty is a ridiculous one."~Voltaire

        Comment


        • #34
          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.
          Diane
          www.dermoneuromodulation.com
          SensibleSolutionsPhysiotherapy
          HumanAntiGravitySuit blog
          Neurotonics PT Teamblog
          Canadian Physiotherapy Pain Science Division (Archived newsletters, paincasts)
          Canadian Physiotherapy Association Pain Science Division Facebook page
          @PainPhysiosCan
          WCPT PhysiotherapyPainNetwork on Facebook
          @WCPTPTPN
          Neuroscience and Pain Science for Manual PTs Facebook page

          @dfjpt
          SomaSimple on Facebook
          @somasimple

          "Rene Descartes was very very smart, but as it turned out, he was wrong." ~Lorimer Moseley

          “Comment is free, but the facts are sacred.” ~Charles Prestwich Scott, nephew of founder and editor (1872-1929) of The Guardian , in a 1921 Centenary editorial

          “If you make people think they're thinking, they'll love you, but if you really make them think, they'll hate you." ~Don Marquis

          "In times of change, learners inherit the earth, while the learned find themselves beautifully equipped to deal with a world that no longer exists" ~Roland Barth

          "Doubt is not a pleasant mental state, but certainty is a ridiculous one."~Voltaire

          Comment


          • #35
            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, 10:54 AM.
            Jo Bowyer
            Chartered Physiotherapist Registered Osteopath.
            "Out beyond ideas of wrongdoing and rightdoing,there is a field. I'll meet you there." Rumi

            Comment


            • #36
              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.

              Comment


              • #37
                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, 04:36 PM.
                Diane
                www.dermoneuromodulation.com
                SensibleSolutionsPhysiotherapy
                HumanAntiGravitySuit blog
                Neurotonics PT Teamblog
                Canadian Physiotherapy Pain Science Division (Archived newsletters, paincasts)
                Canadian Physiotherapy Association Pain Science Division Facebook page
                @PainPhysiosCan
                WCPT PhysiotherapyPainNetwork on Facebook
                @WCPTPTPN
                Neuroscience and Pain Science for Manual PTs Facebook page

                @dfjpt
                SomaSimple on Facebook
                @somasimple

                "Rene Descartes was very very smart, but as it turned out, he was wrong." ~Lorimer Moseley

                “Comment is free, but the facts are sacred.” ~Charles Prestwich Scott, nephew of founder and editor (1872-1929) of The Guardian , in a 1921 Centenary editorial

                “If you make people think they're thinking, they'll love you, but if you really make them think, they'll hate you." ~Don Marquis

                "In times of change, learners inherit the earth, while the learned find themselves beautifully equipped to deal with a world that no longer exists" ~Roland Barth

                "Doubt is not a pleasant mental state, but certainty is a ridiculous one."~Voltaire

                Comment


                • #38
                  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.
                  Barrett L. Dorko

                  Comment


                  • #39
                    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....
                    We don't see things as they are, we see things as WE are - Anais Nin

                    I suppose it's easier to believe something than it is to understand it.
                    Cmdr. Chris Hadfield on rise of poor / pseudo science

                    Pain is a conscious correlate of the implicit perception of threat to body tissue - Lorimer Moseley

                    We don't need a body to feel a body. Ronald Melzack

                    Comment


                    • #40
                      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?
                      Ryan MB Hoffman, PhD
                      Guild Certified Feldenkrais Practitioner

                      Comment


                      • #41
                        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.
                        John Ware, PT
                        Fellow of the American Academy of Orthopedic Manual Physical Therapists
                        "Nothing can bring a man peace but the triumph of principles." -R.W. Emerson
                        “If names be not correct, language is not in accordance with the truth of things. If language be not in accordance with the truth of things, affairs cannot
                        be carried on to success.” -The Analects of Confucius, Book 13, Verse 3

                        Comment


                        • #42
                          Interesting thread. Good to see new people here.


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

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