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The Restiffic Foot Wrap for Restless Legs Syndrome

Discussion in 'General Issues and Discussion Forum' started by Craig Payne, Jun 27, 2016.

  1. Craig Payne

    Craig Payne Moderator

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    I have been following the development of this product for a while. It is a foot wrap designed to place pressure on the foot muscles (specifically abductor hallucis and flexor hallucis brevis) to relive the symptoms of restless legs syndrome (image below).

    It caught my attention as they were using false claims that the product was FDA approved and bad science to claim how good it was.

    It went on sale earlier this month for USD$349.00

    Up until recently, the only information available was the submission to the FDA (here) and a conference abstract on a study (here). The products website which was only recently developed was short on any real useful information.

    The company was claiming that the product was FDA approved when it was not. The product was simply cleared by the FDA as safe. To claim it was approved by the FDA can open the company to action from the FDA for that claim (the FDA guidelines are clear on this). Recently the company does appear to have backed away from this claim, but they still do seem to be strongly implying that it is approved.

    The abstract of the study showed very good results; BUT it did not have a control group and uncontrolled studies tend to massively overestimate the effect size. That did not stop the company making strong claims about how effective it was. The study is now published in full (press release and abstract below). It was published in a low quality journal and it does claim to have a "control group", when it does not (which could be why a high quality journal would not publish the study). They compare the results obtained in this study with the results obtained in drugs trials of completely different studies (ie totally different patient populations!!!!). I could be easy to pick a "control" group from any other study(s) or meta-analyses of other interventions that had poor results or good results to compare the results of the Restiffic study with --> surely the problems of doing that are obvious.

    The authors and the companies use of these results do not acknowledge just how inappropriate and bad science this is! The authors do not acknowledge the issue of doing a statistical analysis between these two unrelated groups!

    I have no doubt that this product will be of some use (the within groups analysis of an uncontrolled study shows good results); but the claims being made for it need to be based on a properly controlled study and not fake claims about FDA approval and exaggerated claims from an uncontrolled study.

    I certainly do hope that the product is effective; as, in general, interventions for restless legs syndrome are typically unsatisfactory and I do have empathy for those with it.

    Below: abstract; press release; video; image

    Targeted Pressure on Abductor Hallucis and Flexor Hallucis Brevis Muscles to Manage Moderate to Severe Primary Restless Legs Syndrome
    Phyllis J. Kuhn, MS, PhD; Daniel J. Olson, DPM; John P. Sullivan, MD
    The Journal of the American Osteopathic Association, July 2016, Vol. 116, 440-450. doi:10.7556/jaoa.2016.088
    PUBLIC RELEASE: 27-JUN-2016
    Foot wrap offers alternative to medication for patients with restless legs syndrome
    Pilot study published in the Journal of the American Osteopathic Association finds targeted pressure device significantly increased sleep for those with moderate to severe symptoms
     

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    Last edited by a moderator: Sep 22, 2016
  2. Admin2

    Admin2 Administrator Staff Member

  3. Craig Payne

    Craig Payne Moderator

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  4. Craig Payne

    Craig Payne Moderator

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    Disappointing to see how many more news websites are just parroting the press release with no critical thinking skills. Poor journalism.
     
  5. drhunt1

    drhunt1 Well-Known Member

    $349 for the devices? I've got a better idea. Why not just use that money to purchase orthotics and be done with it? At least the authors have determined the foot is the source of the malady...just a little too distal.
     
  6. Craig Payne

    Craig Payne Moderator

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    Just a follow up on this bit:
    The reason you need a control group with the same characteristics as the intervention group is that in the statistical analysis you subtract the placebo effect of the control group from the treatment effect in the intervention group to get the real effect of the intervention.

    That is why uncontrolled studies massively overestimate effect sizes (like the above study).

    I know they claimed to have a "control" group, but they did not. They just used a reference group from a meta-analysis of other studies to compare their outcome to!!

    The reason I raise this again, is that this just turned up in my alerts:
    Placebo Exerts Strong Effects in Restless Legs Trials (registration needed to read)
    That throws a very big question mark over the uncontrolled study being used to market the Restiffic device.
     
  7. Craig Payne

    Craig Payne Moderator

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    6
    I knew it would not be long before posts started turning up in RLS groups on facebook. The first response is not impressed!
     

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  8. drhunt1

    drhunt1 Well-Known Member

    Reminds me of someone here berating my study because I didn't use a "placebo" orthotic...whatever that is supposed to be. A 30 patient study falls more into the category of case studies, instead of a large enough group for serious statistical analysis. In my study, the control group were those that had the treatment taken away, the symptoms returned, and then responded favorably once treatment, (orthotics), were again introduced. In case studies...there are dependant variables, independent variables and a control group.

    This device, and the study to show efficacy is doomed for failure because it doesn't address the root cause of RLS. And it sure as heck isn't iron deficiency either.
     
  9. NewsBot

    NewsBot The Admin that posts the news.

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    Last edited by a moderator: Sep 22, 2016
  10. Craig Payne

    Craig Payne Moderator

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    The company has produced this chart. One of the claims in the chart is possibly liable to action by the FTC
     

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  11. Craig Payne

    Craig Payne Moderator

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    I guess they have no idea how close they are to coming under FTC scrutiny:
     

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  12. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Press Release:
    Restiffic Restless Leg Foot Wrap Available in United Kingdom
     
  13. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Press Release:
    Restiffic Restless Leg Foot Wrap Available in Pharmacies
     
  14. Craig Payne

    Craig Payne Moderator

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    Nope. Placebo effect is strong on RLS due to involvement of dopamine pathways. As I said above, without the use of an adequate control group, they can not make these claims.
    Total horse manure. You can't compare results from an uncontrolled study to the results in other studies on different patient populations.

    Time for the FDA and/or FTC to intervene.
     
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