The RESTIFFIC™ Foot Wrap is a foot wrap that is designed to help the symptoms of restless legs syndrome that places targeted, adjustable squeeze pressure on the abductor hallucis and flexor hallucis brevis muscles in the foot during periods of rest. An outer cloth wrap holds "T" shaped pads in place over the muscles on the bottom of the foot.
Not a lot is currently known about this device. It has been cleared by the FDA as a safe device for restless leg syndrome. The FDA application indicated that the device will be prescription only. The domain name restiffic.com was registered in Feb 2015, but as at September 2015, there was no website there and just a placeholder. In early November 2015, the website appears to being developed to sell the product with an announcement that the product would be available for sale on 6 June 2016. It is now on sale for USD$349.95.
One preliminary study has been done with the Restiffic wrap. It did not have a proper control group. There was an improvement in symptoms in the group in the study with the wrap, but uncontrolled studies (or studies with historical reference or control groups) tend to overestimate the treatment effects. The trial was registered but has only been presented as a conference abstract and not published in full; (it has now been published).
- The study that is being used to support the product has been widely criticized as not having a proper control group (it used a reference group from other studies on different patient populations). Given the placebo effect in restless legs syndrome is high, the results of the study need to be interpreted with caution.
- There has been some negative responses in social media to the price of the product.
- The FDA has cleared the product as being safe. The is not the same as the use of the phrase on the Restiffic website of "FDA approved" implying approval as to its efficacy. The FDA application linked above was an application to classify the device as a 'Class 1' and therefore exempt from the typical pre-market testing required to be "FDA approved" for high risk devices. The company is breaching the FDA labeling and marketing regulations by claiming this as the FDA do not approve de novo devices:
The Restiffic Foot Wrap for Restless Legs Syndrome (Podiatry Arena)
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