An adjustable foot wrap that applies pressure to two muscles in the foot may offer patients with restless legs syndrome an effective alternative to drugs as a way to ease symptoms when trying to rest or go to sleep. In a pilot study, researchers found the device was 1.4 times as effective as a standard drug treatment.
The study, led by Dr. Phyllis Kuhn of the Lake Erie Research Institute in Girard, PA, is published in The Journal of the American Osteopathic Association.
Restless legs syndrome (RLS), also known as Willis-Ekbom disease, is a common disorder of the nervous system that causes unpleasant sensations and an overwhelming, irresistible urge to move the legs when at rest.
Sleep loss associated with RLS can cause extreme fatigue and lead to anxiety and depression.
Estimates suggest RLS may affect as many as 10 percent of Americans, with over 9 million individuals experiencing moderate to severe symptoms.
Strong drugs - including dopamine agonists that increase dopamine in the brain - can be used to relieve RLS symptoms, but they bring unpleasant side effects such as nausea, vomiting, and dizziness. There is also the risk that patients can become dependent or addicted to the medication.
The adjustable foot wrap works by applying pressure to two muscles in the foot - the abductor hallucis and the flexor hallucis brevis - a method that is known to relieve symptoms of RLS.
Applying pressure to these muscles may also stimulate the release of dopamine in the brain, creating an effect similar to that of massage therapy or acupressure.
'Example of the body regulating itself without drugs'
Dr. Kuhn and colleagues carried out an 8-week clinical trial of the adjustable foot wrap in 30 adults (22 women and eight men aged 30-75) who were healthy, apart from experiencing moderate to severe RLS.
The participants wore the adjustable foot wrap - one on each foot - for set periods intermittently throughout the course of the study.
The researchers used standard questionnaires - the Clinical Global Impression and the International Restless Leg Syndrome Study Group Study Scale (IRLSSGS) - to assess outcomes.
They then pooled and analyzed the results with those of three other studies that used the same measures to assess effectiveness of the medication ropinirole and a placebo. Ropinirole, a dopamine agonist, is a standard drug treatment for RLS.
On the Clinical Global Impression measure, the foot wrap had a 90 percent improvement, compared with 63 percent for ropinirole. Also, on the IRLSSGS, the foot wrap scored 17.22 compared to ropinirole versus placebo (12 versus 8.9, respectively).
Participants using the foot wrap also reported an 82 percent drop in sleep loss.
Seven of the participants reported experiencing side effects, including irritability (3 participants), sensations like pins and needles (2), pain (1), spasm (1), and warm feet (1).
"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. It's a near perfect example of the body regulating itself without drugs, many of which have the potential for significant adverse side effects."
Dr. Phyllis Kuhn
In the following video, Dr. Kuhn explains in more detail how the approach works: