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
Authors from Lake Erie Research Institute in Pennsylvania report an adjustable foot wrap caused to treat restless legs syndrome (RLS) is 1.4 times more effective than the standard pharmaceutical treatment. The pilot study published today in The Journal of the American Osteopathic Association.
The eight-week clinical trial involved 30 otherwise healthy adults with moderate to severe restless leg syndrome. Researchers studied Clinical Global Impression responses as well as the mean change in the International Restless Leg Syndrome Study Group Study Scale (IRLSSGS). A meta-analysis was then used to compare the RLS device with three historic studies of the medication ropinirole and a placebo.
Clinical Global Impression responses indicated significantly greater improvement with the RLS device (90 percent) compared with ropinirole (63 percent), the current standard dopamine therapy for RLS. Additionally, change in IRLSSGS score was significantly greater for the RLS device (17.22) compared to historic reports for ropinirole versus the placebo (12 versus 8.9 respectively). Patients using the RLS device also reported an 82 percent decrease in sleep loss.
The RLS device was designed to put adjustable targeted pressure on two muscles in the foot known to relax symptoms of RLS, the abductor hallucis and the flexor hallucis brevis. Researchers indicate that the pressure produced by the device may also stimulate a dopamine release, similar to massage therapy or acupressure.
“By putting pressure on specific muscles in the feet, we are able to create a response in the brain that relaxes the muscles activated during RLS,” said Phyllis Kuhn, MS, PhD, and the study’s lead researcher. “It’s a near perfect example of the body regulating itself without drugs, many of which have the potential for significant adverse side effects.”
Restless leg syndrome (RLS) is a neurologic disorder causing unpleasant sensations and an urge to move the legs when at rest. The sleep loss associated with RLS can cause extreme fatigue, anxiety and depression. According to the National Institute of Health, RLS may affect as many as 10 percent of the U.S. population, with more than nine million experiencing moderate to severe symptoms.
Until recently, potent drugs including opioids, depressants and dopamine agonists have been used to ease symptoms, but each of these is accompanied by negative side effects such as dizziness, nausea, vomiting and the added risk of addiction.
“Restless legs syndrome really erodes quality of life because it causes extreme fatigue for many patients. As an osteopathic physician, it’s a challenge to balance the need to restore sleep while preventing additional harm from medication. These results show promise in otherwise healthy individuals for a nonpharmaceutical option that appears to have rather minor, temporary adverse effects for some users,” said Rob Danoff, DO, an osteopathic family physician and program at Aria Health Care in Philadelphia.
Adverse effects were reported by seven patients in the study. The effects included pain (1), pins and needles sensation (2), irritability (3), spasm (1) and warm feet (1).
Open access to the full review is available until September 1, 2016: http://jaoa.org/article.aspx?articleid=2531565.
Disclosures: Dr Kuhn worked without compensation through Lake Erie Research Institute (LERI) during the 5 years of the study of the device and is now receiving compensation for that work. She reports no financial interest in its sales. None of the other study authors reported any conflict of interest or financial disclosure relevant to the topic of this study. More details are available in the published article.
About The Journal of the American Osteopathic Association
The Journal of the American Osteopathic Association (JAOA) is the official scientific publication of the American Osteopathic Association. Edited by Robert Orenstein, DO, it is the premier scholarly peer-reviewed publication of the osteopathic medical profession. The JAOA’s mission is to advance medicine through the publication of peer-reviewed osteopathic research.
This news release about a foot wrap device to treat symptoms of restless leg syndrome tries to portray study results as newer, more novel and more distinctive than they really are. While the study was just published in the Journal of the American Osteopathic Association, the results were submitted to the FDA more than five years ago and the key findings have been used to market the device that was cleared for sale in 2013. Besides omitting the history of the study, the release promotes this foot wrap as if it were the only alternative to drug treatment, when there are other devices also on the market, as well as recommendations for massage, hot baths, lifestyle changes and other ways people can try to control bothersome leg movements.
The release would have been stronger had it noted that the device is already on the market, and at what cost. More details on the trial results, including limitations, as found in the published study, would also have been useful.
Restless leg syndrome (RLS) is a common but poorly understood neurological condition that leads to discomfort in the lower legs. For most individuals, the symptoms are mild and mainly impact sleep. For those with more severe symptoms, the discomfort in the legs can also be bothersome during the day.
More than nine million people in the US may be dealing with moderate to severe RLS. Several times that many have milder symptoms or similar conditions they may confuse for RLS. That means that many millions of people may be misled by a news release that misstates the novelty of a foot wrap device and the study being used to promote it. The potential for confusion is demonstrated by the number of news organizations that apparently believed these study results are new, when they’ve been circulating for years and used in product marketing since at least early 2015.
The release does not mention that this foot wrap sells for $350 per pair. This may be less expensive than the cost of medicines used to treat RLS, something that could have been pointed out as a favorable thing.
The release reports summaries of two types of measures of restless leg syndrome. However, the release would have been better if, in addition to the numerical results for the two scales, it had offered some definition of what the numbers mean in more common terms, such as how many nights per week people lost a lot of sleep because of leg movements. Or, since this treatment is focused on improving sleep, one could have focused on the number of nights with uninterrupted sleep.
And as noted below, the release offers a comparison only to one type of drug, without any reference to numerous alternatives.
The release reports the number of participants who had problems including “pain (1), pins and needles sensation (2), irritability (3), spasm (1) and warm feet (1).”
Although the release calls the study a “pilot” and reports that it was an 8-week open label test involving just 30 people, and that the comparison to drug treatment used a statistical method for comparing this new trial with published reports of earlier trials done by drug companies, overall the release soft-pedals these limitations and fails to mention others. For instance, the release does not mention that originally 47 people were enrolled, with 11 being dropped for various reasons before being given the foot wrap and then six more dropping out during the trial. The study used a method of accounting for drop outs known as “last observation carried forward.” which means that they filled in the empty data points with the same report as the last one received before a patient dropped out. This method can indicate greater efficacy than assuming that an intervention produces no benefit after a person drops out. The release could have more clearly pointed out that there was no placebo control or blinding.
The release includes a quote from one of the researchers claiming that with this device “we are able to create a response in the brain that relaxes the muscles activated during RLS.” when actually there was nothing in this study that reveals anything about how the foot wrap might work. It would have been better for the release to stick to the language used in the journal article, in which the researchers proposed their ideas about how the device might affect nerve signals, without claiming this study supports any particular proposed mechanism.
The release quotes the National Institute [sic] of Health as saying more than nine million people in the US experience moderate to severe restless leg symptoms similar to those of the participants in this trial. However, it would have been helpful for the release to also point out that the NIH says 70 to 80 percent of people with RLS have a milder form, and that people who report leg movements during sleep have different conditions, such as “periodic limb movement of sleep” (PLMS).
We will give the release credit for clearly noting that one of the authors works with the Lake Erie Research Institute, which developed the foot wrap, and that she is receiving compensation for her research work. The release also points out that further disclosure details are listed in the journal article. However, the release could have also specifically mentioned that the additional disclosure information includes the fact that the institute receives royalties from the company that bought the rights to the foot wrap.
While at first glance it appears that the trial and the release are a comparison with the existing alternative of drug treatment, the release makes no reference to lifestyle changes, massage, hot or cold packs, hot baths, compression sleeves or an FDA-approved vibrating pad (brand name Relaxis), which has gone through far more extensive testing than this foot wrap. Since the main point of the release is to promote an alternative to drug treatment of RLS, failing to mention the FDA-approved vibration device is a serious omission.
Oddly, the release does not say that this foot wrap was cleared for sale by the FDA in 2013 and is already on the market (brand name restiffic).
As noted above, the release does not mention compression sleeves or other similar devices. Nor does the release mention that data from this “new” study was submitted to the FDA more than five years ago and has been widely used to market the restiffic device.
The release doesn’t use sensationalist language. But it’s still a problem that the release presents this foot wrap as if it were the first and only non-drug treatment for RLS and thus offers something entirely new to patients.