MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

We recently discussed the deplorable case of Larry Nassar and the fact that the ‘American Osteopathic Association’ stated that intravaginal manipulations are indeed an approved osteopathic treatment. At the time, I thought this was a shocking claim. So, imagine my surprise when I was alerted to a German trial of osteopathic intravaginal manipulations.

Here is the full and unaltered abstract of the study:

Introduction: 50 to 80% of pregnant women suffer from low back pain (LBP) or pelvic pain (Sabino und Grauer, 2008). There is evidence for the effectiveness of manual therapy like osteopathy, chiropractic and physiotherapy in pregnant women with LBP or pelvic pain (Liccardione et al., 2010). Anatomical, functional and neural connections support the relationship between intrapelvic dysfunctions and lumbar and pelvic pain (Kanakaris et al., 2011). Strain, pressure and stretch of visceral and parietal peritoneum, bladder, urethra, rectum and fascial tissue can result in pain and secondary in muscle spasm. Visceral mobility, especially of the uterus and rectum, can induce tension on the inferior hypogastric plexus, which may influence its function. Thus, stretching the broad ligament of the uterus and the intrapelvic fascia tissue during pregnancy can reinforce the influence of the inferior hypogastric plexus. Based on above facts an additional intravaginal treatment seems to be a considerable approach in the treatment of low back pain in pregnant women.
Objective: The purpose of this study was to compare the effect of osteopathic treatment including intravaginal techniques versus osteopathic treatment only in females with pregnancy-related low back pain.
Methods: Design: The study was performed as a randomized controlled trial. The participants were randomized by drawing lots, either into the intervention group including osteopathic and additional intravaginal treatment (IV) or a control group with osteopathic treatment only (OI). Setting: Medical practice in south of Germany.
Participants 46 patients were recruited between the 30th and 36th week of pregnancy suffering from low back pain.
Intervention Both groups received three treatments within a period of three weeks. Both groups were treated with visceral, mobilization, and myofascial techniques in the cervical, thoracic and lumbar spine, the pelvic and the abdominal region (American Osteopathic Association Guidelines, 2010). The IV group received an additional treatment with intravaginal techniques in supine position. This included myofascial techniques of the M. levator ani and the internal obturator muscles, the vaginal tissue, the pubovesical and uterosacral ligaments as well as the inferior hypogastric plexus.
Main outcome measures As primary outcome the back pain intensity was measured by Visual Analogue Scale (VAS). Secondary outcome was the disability index assessed by Oswestry-Low-Back-Pain-Disability-Index (ODI), and Pregnancy-Mobility-Index (PMI).
Results: 46 participants were randomly assigned into the intervention group (IV; n = 23; age: 29.0 ±4.8 years; height: 170.1 ±5.8 cm; weight: 64.2 ±10.3 kg; BMI: 21.9 ±2.6 kg/m2) and the control group (OI; n = 23; age: 32.0 ±3.9 years; height: 168.1 ±3.5 cm; weight: 62.3 ±7.9 kg; BMI: 22.1 ±3.2 kg/m2). Data from 42 patients were included in the final analyses (IV: n=20; OI: n=22), whereas four patients dropped out due to general pregnancy complications. Back pain intensity (VAS) changed significantly in both groups: in the intervention group (IV) from 59.8 ±14.8 to 19.6 ±8.4 (p<0.05) and in the control group (OI) from 57.4 ±11.3 to 24.7 ±12.8. The difference between groups of 7.5 (95%CI: -16.3 to 1.3) failed to demonstrate statistical significance (p=0.93). Pregnancy-Mobility-Index (PMI) changed significantly in both groups, too. IV group: from 33.4 ±8.9 to 29.6 ±6.6 (p<0.05), control group (OI): from 36.3 ±5.2 to 29.7 ±6.8. The difference between groups of 2.6 (95%CI: -5.9 to 0.6) was not statistically significant (p=0.109). Oswestry-Low-Back-Pain-Disability-Index (ODI) changed significantly in the intervention group (IV) from 15.1 ±7.8 to 9.2 ±3.6 (p<0.05) and also significantly in the control group (OI) from 13.8 ±4.9 to 9.2 ±3.0. Between-groups difference of 1.3 (95%CI: -1.5 to 4.1) was not statistically significant (p=0.357).
Conclusions: In this sample a series of osteopathic treatments showed significant effects in reducing pain and increasing the lumbar range of motion in pregnant women with low back pain. Both groups attained clinically significant improvement in functional disability, activity and quality of life. Furthermore, no benefit of additional intravaginal treatment was observed.

END OF QUOTE

My first thoughts after reading this were: how on earth did the investigators get this past an ethics committee? It cannot be ethical, in my view, to allow osteopaths (in Germany, they have no relevant training to speak of) to manipulate women intravaginally. How deluded must an osteopath be to plan and conduct such a trial? What were the patients told before giving informed consent? Surely not the truth!

My second thoughts were about the scientific validity of this study: the hypothesis which this trial claims to be testing is a far-fetched extrapolation, to put it mildly; in fact, it is not a hypothesis, it’s a very daft idea. The control-intervention is inadequate in that it cannot control for the (probably large) placebo effects of intravaginal manipulations. The observed outcomes are based on within-group comparisons and are therefore most likely unrelated to the treatments applied. The conclusion is as barmy as it gets; a proper conclusion should clearly and openly state that the results did not show any effects of the intravaginal manipulations.

In summary, this is a breathtakingly idiotic trial, and everyone involved in it (ethics committee, funding body, investigators, statistician, reviewers, journal editor) should be deeply ashamed and apologise to the poor women who were abused in a most deplorable fashion.

18 Responses to Intravaginal manipulations by (German) osteopaths: a new low point for clinical research into alternative medicine?

  • “an approved osteopathic treatment” for what?
    More bizarre nonsense from non-med. What next, SCT for back pain? Anything is possible for people for whom medicine is up to the imagination.

  • This is a rare example of a trial with an A+B vs B design in which A did not show a beneficial effect.

    This is not to detract from the main issue: “breathtakingly idiotic” seems to me a restrained characterization of this ridiculous trial.

  • A few years ago, a vicar in Sheffield, trying different ways of enticing people into his cult,organised ‘evening services’, and was put on trial for conning naive, gullible women into agreeing to what he called ‘ internal massage’.
    The Lord does, indeed, move in mysterious ways.

  • Licciardone et al. 2010, found usual obstetrical care (UOC) and osteopathic manipulative treatment (OMT) to be more effective than usual care alone (Roland Morris-Disability Questionnaire to assess back-specific functioning) but not more effective than usual obstetric care and sham ultrasound treatment (SUT). No between group significance was found for back pain. This trial had 144 subjects.

    The authors concluded: “Osteopathic manipulative treatment slows or halts the deterioration of back-specific functioning during the third trimester of pregnancy.”
    https://www.ncbi.nlm.nih.gov/pubmed/19766977

    I don’t believe any comment is necessary.

    In May 2017 Licciardone commented on a larger study by Hensel et al. (PROMOTE), on 400 women:

    …it failed to demonstrate a significant benefit in any primary outcome in women receiving OMT as compared with those receiving placebo ultrasound therapy.2(Table 4) In fact, women who received OMT reported worse outcomes on both the composite measure of pain and RMDQ. Although significant benefits were reported for composite pain and RMDQ when comparing OMT+UOC vs UOC,2(Table 4) neither outcome reflected a treatment effect that was clinically relevant according to evidence standards.
    http://jaoa.org/article.aspx?articleid=2625275

    Hardly a ringing endorsement of OMT for back pain in pregnancy.

    Certainly no reason for supposing that intravaginal manipulation might be of any use whatsoever during pregnancy.

    A classic example of how sandcastles are built upon sandcastles upon… in the sandcastles-all-the-way-down world of CAM.

  • Please read Appendix F, pages 2 and 3 – the submission of the Manitoba Chiropractors Association (MCA) to our provincial government on the safety of high neck manipulation. In the MCA’s submission, the MCA include a summary of their pending submission related to reserved actions being sought by the MCA. Reserved acts are acts that pose a significant risk of harm to the public and that are reserved for only health professions that have the expertise, skill and training to perform those reserved acts.

    I must be reading this wrong, I must be!!!

    https://www.gov.mb.ca/health/rhpa/docs/appendix_f.pdf

    • Wow! Items 4(e) and 4 (f) relate directly to the theme of this blog post and suggest that osteopaths don’t have a monopoly in this area. Maybe chiros have found a new use for their ‘activator’ clickety sticks?

  • Having received a full training in OMM/OMT Osteopathic Manipulative Medicine/ Osteopathic Manipulative Treatment including a full training in Visceral Manipulation and a full training in Osteopathy in the Cranial Field and being legally licensed as an osteopath by the Swiss health department authorities and being an advisor for the Board of the biggest German Osteopathic Association for a few years I must say:

    All “therapists” and responsible persons involved in this “study” must send a written apology to the women taking part in this “study” quoted in the link above.

    After Larry Nassar an US osteopathic physician D.O. was sentenced on Jan. 24th 2018 to 40 to 175 years in prison for the abuse of hundreds of children and young women in the name of Visceral Osteopathy with intravaginal fondling so called “intravaginal manipulation” (former Thure Brandt Massage) such visceral trainings and “treatments” and “studies” in this subject must be terminated at once by the authorities of US osteopathic physician´s D.O. or B.Sc. or M.Sc. or other osteopathic trainings around the world at universities university colleges or colleges. Visceral Osteopathy is without any evidence for reliability of diagnosis or clinical efficacy but it can be harmful. The application of such “intraanal or intravaginal techniques” on babies children and young people must be prohibited at once by the health department authorities.
    See:
    Reliability of diagnosis and clinical efficacy of visceral osteopathy: a systematic review.
    17th February 2018
    https://www.ncbi.nlm.nih.gov/pubmed/29452579

    • “being an advisor” is cramatically incorrect. I want to mention the correct facts: I terminated my membership in this German association of osteopaths and my function as an advisor to the board years ago. The reason was that I couldn´t see any option and had no chance to stop the pseudoscientific and esoteric tendencies which are the mainstream in European and Commonwealth “osteopathy” nowadays.

      • The last insurrection I took part in was at the ESO in Maidstone in an M.Sc. (ost) course “Osteopathy in Obstetrics” as we as students refused to listen to a French osteopath D.O. teaching manipulative techniques for the pelvic floor using explanations of transgenerational osteopathy and Tarot cards for diagnosis. This was a laughing stock as part of an M.Sc. program offered together with the University of Greenwich.

  • An important question: Why do we have all these alternative treatments to lower back pain?

    Answer: Because science-based medicine is so inefficient in treating lower back pain. If science-based medicine was effective in treating LBP there would be little demand for alternative treatments. So, if you are a proponent of science-based medicine, instead of putting effort on showing how bad an alternative treatment is, try to improve science-based treatments. The same applies to any medical problem: if science-based medicine provides good treatment there is smaller demand for alternatives.

    • are you saying that, as long as there is no perfect method of bomb-detecting, it is ok to sell fake bomb-detectors?

      • No, I am not saying that. I am not talking about bomb detectors, but treatments for lower back pain. They are two different things.

        The problem is that medical science does not provide effective treatments for many musculoskeletal problems and pain. The current opioid epidemic in America is one result of this problem. Because doctors have no effective treatment for a condition, they prescribe opioids heavily advertised by pharmaceutical companies, many patients get addicted, and 50,000 people die yearly in America.

        The demand for alternative treatments is caused by the lack of effective science-based treatments. These alternative treatments are in general even less effective, but they do not cause the death of 50,000 people yearly in America.

        • “These alternative treatments are in general even less effective, but they do not cause the death of 50,000 people yearly in America.”
          neither does good, responsible medicine do that!
          the opioid epidemic is a phenomenon of bad US medicine.

        • The demand for alternative treatments is caused by the lack of effective science-based treatments

          Wrong. The demand for alternative treatments is primarily caused by alternative practitioners who lure patients with false claims of solutions that real medicine can’t offer. The fact that many of these alternative practitioners also suffer from self-deception about their purported knowledge and skills does not change this in any fundamental way – because they still knowingly and willingly choose to ignore the huge body of scientific evidence that what they’re doing is useless quackery.

          IOW: Saying that a lack of effective regular treatments drives the demand for alternative treatments is like saying that a lack of money drives the demand for Ponzi schemes. It steers away from the fundamental fact of deception taking place.
          What there is, however, is a demand for effective treatments. Which unfortunately don’t exist for many conditions.

    • Rephrasing the important question: Why do we have all these ineffective (or at best as effective as conventional) alternative treatments to lower back pain?

      • Because lower back pain is one of the quack guild’s favourite conditions:
        – very common
        – no well-understood etiology
        – no effective treatment
        – largely unpredictable in onset, progression, and resolution
        – relatively sensitive to placebo treatments, at least in the short term
        – quite burdensome yet usually harmless.
        All this together means that almost any type of quackery can (and will) sooner or later evoke an illusion of improvement, without any serious risk of harm.

  • More evidence based critical comments and relevant professional studies on „osteopathy / Osteopathie“ and “VM-Visceral Manipulation / Visceral Osteopathy” and “Cranial Osteopathy” posted by an osteopathic manual practitioner and naturopath having professional licenses granted by Swiss and German health departments and who is fully trained in all of such subjects you might find under:

    https://plus.google.com/u/0/b/106852599210601350980/collection/AsbPMF

    https://plus.google.com/u/0/b/106852599210601350980/collection/gC8DTE

  • The study was carried out in association with the Osteopathic Research Institute in Hamburg. Therefore, I do not wonder why the ethics committee allowed the research:
    https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00010416
    It was registered restospectively. The hole process seems to be deeply problematic. A private research institute establishes there own ethics committee and proceeds human studies. Is this an established procedure for alternative medicine? Is this a larger problem?
    Even though the University of Hamburg seems to be involved, according to the registration of the study, the ethics committee of the university is not mentioned in the registration. This seems to be problematic as well.

    The conclusion of the study is so fishy formulated. Saying there had been statistic significant recovery of pain, which has nothing to do with the intervention. Taken together with the method part with naming it “randomized control study” is clearly missleading.

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