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).
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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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