A new pilot study published in The Journal of the American Osteopathic Association reported that an adjustable foot wrap is 1.4 times more effective in treating restless leg syndrome (RLS) than traditional pharmaceutical therapy. Authors at Lake Erie Research Institute in Pennsylvania published this study.
Thirty otherwise healthy people with moderate to severe restless leg syndrome participated in this 8-week clinical trial. Scientists analyzed the mean changes in the International Restless Leg Syndrome Study Group Study Scale (IRLSSGS), as well as the Clinical Global Impression responses. They used a combined analysis method to compare a few historic studies of a placebo and the drug ropinirole (the current standard therapy for RLS) with the RLS foot device.
Responses on the Clinical Global Impression showed more improvement (90%) with the RLS device than was seen with ropinirole (63%). Furthermore, the IRLSSGS scores were much greater for the device at 17.22 when compared to the ripinirole versus placebo effect, which was 12 and 8.9, respectively. The individuals who were using the device reported an 82% decrease in loss of sleep.
The device for RLS was made adjustable to target pressure on two muscles in the feet that are known to have a relaxing effect for RLS sufferers. These are the flexor hallucis brevis and the abductor hallucis. The researchers report that the pressure on these muscles by the foot RLS device may also release dopamine, having a similar effect to acupuncture or massage therapy.
Dr. Phyllis Kuhn, MS, PhD, the study’s lead researcher, states that pressure on those specific muscles made it possible for them to create brain responses that relax the activated muscles in RLS cases. The researchers believe this is a prime example of the body’s ability to regulate itself without the use of pharmaceutical medications, many of which have dangerous side effects.
RLS is a neurological condition that results in extremely unpleasant sensations with an urge to move the legs constantly when at rest. RLS is often related to PLMS. This is usually most prominent when lying down to sleep, which is why this condition often results in significant sleep loss, leading to excessive fatigue, depression, and anxiety. The National Institute of Health reports that RLS may be present in at least 10% of the American population, with more than 9 million people having moderate to severe symptoms.
To ease RLS symptoms, extremely potent medications have been used, including antidepressants, opioids, and dopamine agonists. Until recently, that is. As each of these medications come with some severe side effects like nausea, vomiting, dizziness, and risk of addiction, many providers and patients are moving away from their use.
Dr. Rob Danoff, DO, believes that this condition truly interferes with quality of life because of the loss of sleep that leads to the excess fatigue. As an osteopathic practitioner, Dr. Danoff believes that the challenge is in balancing the need to restore sleep while simultaneously preventing adverse reactions and harmful effects of the medications. The results of this study offer a healthy alternative to treating RLS.
It is notable that there were some adverse effects reported in the study by seven individuals. These included one person with pain, two people with a sensation of pins and needles, three people with irritability, one person with spasm, and one person with warm feet.
Author: Rachael Herman is a professional writer with an extensive background in medical writing, research, and language development. Her hobbies include hiking in the Rockies, cooking, and reading.
© 2021 American Sleep Association.