Featured image caption: The restiffic compressive foot wrap is one of many non-drug therapies that should be in the armamentarium of clinicians who treat the disorder.

From exercise to sleep hygiene to foot wraps and medical devices, non-drug alternative treatments for RLS can decrease symptoms.

The primary goal of treatment for restless legs syndrome (RLS), also known as Willis-Ekbom disease (WED) or Ekbom disease (EKD), is to manage symptoms and improve patient function and quality of life.1 Treatments for this neurological disorder include non-pharmacological and pharmacological options, though the latter is generally reserved for patients with severe RLS.2 Certain lifestyle changes, exercise, and treatment modalities, as well as alternative medicine, are linked to a decrease of symptoms associated with RLS.2 This article will explore non-pharmacological alternatives for the treatment of RLS and how these solutions can benefit patients.

Importance of Non-Drug Treatments

“Pharmaceutical treatment has long been touted as the only medically proven treatment option for RLS, so it is important to raise awareness of non-drug treatment options that have been proven to be safe and effective by the FDA,” says Dean Bender, vice president of marketing & business development at medi USA, maker of the restiffic compressive foot wrap that was recently FDA cleared as a Class 1 device. “Existing drug treatments put patients at risk for addiction, worsening of RLS symptoms, negative interactions with other medical treatments, and a myriad of other dangerous and life-threatening side effects.”

Brian Koo, MD, assistant professor of neurology at Yale and director of the Yale Center for Restless Legs Syndrome, says non-pharmacologic treatments such as stretching and exercise are important because they can offer patients relief from symptoms as well as improve sleep.

Mark Buchfuhrer, MD, FRCP(C), FCCP, FASSM, consulting assistant professor at the Stanford School of Medicine and director of the SleepMed sleep lab in Cypress, Calif, says, “Patients do not like to take or be dependent upon medication. Most RLS patients would far prefer to have treatment that is more ‘natural’ and does not involve prescription medication. Using non-drug therapy might allow many patients to completely avoid drug therapy and others to reduce the amount of medication needed to control their symptoms.”

Any effective treatment that can be taken without adversely impacting the central nervous system, which some drugs may do, should be attempted first, says Ulrike Mitchell, PhD, PT, OCS, associate professor at Brigham Young University. “Non-drug treatments usually have minimal to no side effects and are therefore considered by many to be safer. That element makes non-drug treatment very important for patients and should be considered,” says Mitchell.

Advantages of Non-Drug Therapies

Advantages of non-pharmacologic treatments compared with pharmacologic agents include less or no side effects, no danger of augmentation, and less cost.2 Buchfuhrer says he will typically suggest non-drug therapy for patients with mild RLS symptoms who may be able to avoid taking drugs. “I often see patients in consultation who are already on medication (usually multiple drugs) and not doing well. When non-drug therapy is not helpful or not appropriate, I then prescribe drugs for RLS symptoms,” says Buchfuhrer. “Non-drug therapy may often help the patient get further or complete relief when combined with their current medications.”

Prescribing of non-drug treatments should include a thorough inventory of a patient’s behaviors and lifestyle, including activity, alcohol intake, herbal medicines, and over-the-counter medications, says Koo, who is also the director of the sleep medicine program at Connecticut Veterans Affairs Healthcare System and on the medical and scientific advisory board of the Restless Legs Syndrome Foundation and editor of the foundation’s magazine NightWalkers.

“I speak about level of activity with all patients. Also, I take a thorough history to make sure that the patient is not engaging in behavior or activity that can worsen RLS,” explains Koo. “It is absolutely essential to take this inventory exhaustively in every RLS patient. After this has been done, non-drug treatments are important [because] in some patients medications for RLS can be avoided.” From hot and cold packs to therapeutic massage, Koo emphasizes that there is no “best” at-home remedy; rather, it is whatever solution works best for the patient.

Mitchell, whose exposure to RLS patients has been as a researcher (she authored the paper “Nondrug-related Aspect of Treating Ekbom Disease, Formerly Known as Restless Legs Syndrome”2 and other studies), says the benefits of non-drug treatments may include partial to full relief of symptoms. Mitchell says, “[This] should improve their quality of life on different levels: they sleep better at night and, therefore, may be less tired during the day affecting their mood. They may [also] be able to resume activities that they hadn’t been able to enjoy.”

Sleep Hygiene

Proper sleep hygiene can be an essential non-drug treatment for RLS patients because, as Koo notes, sleep deprivation is an aggravator of RLS.

Koo also highlights the importance of diagnosing sleep apnea in RLS patients. “It is…essential to make sure that there is not concomitant sleep apnea as RLS can be particularly difficult to treat if sleep apnea is present and not treated,” explains Koo. “Conversely, treating sleep apnea can have profound beneficial effects on the symptoms of RLS.”

Diet

Most of what we know about diet and RLS is based on anecdotal reporting from patients, Buchfuhrer says. “Many RLS patients feel that a reduction in carbohydrates (especially refined) may be helpful while others feel eliminating gluten is helpful. Often, ice cream makes RLS worse,” he says. “I feel that eliminating or limiting alcohol intake is the most beneficial measure for most RLS patients. If a patient finds by trial and error that eliminating certain foods or adopting certain diets helps, then they should do so.”

The restriction of alcohol, as well as caffeine, can also have a positive impact on sleep. Mitchell says, “Since so many RLS sufferers have problems sleeping at night, it would be an ancillary benefit to reduce the intake of caffeine and alcohol, which may help increase the chances of getting a more restful sleep.”

Koo says there is also a link between foods high in carbohydrates and the exacerbation of RLS. As such, restricting high carbohydrate foods and adding foods that contain iron may help.

Physical Activity

A clinical trial showed that a 3-day-per-week exercise program of aerobic and lower-body resistance training significantly decreased RLS symptom severity.3

Mitchell theorizes that physical activity results in increased blood flow to the extremities, which improves oxygenation and thus decreases the urge to move that is characteristic of RLS.

Another possible reason could be the exercise-induced release of endorphins.2 A further potential mechanism is the increased release of dopamine.2

Buchfuhrer says studies and experience have shown that mild to moderate regular exercise can help reduce RLS symptoms. “Immediate physical activity relieves RLS and the longer the activity duration, the longer the relief may last after stopping the activity,” explains Buchfuhrer. “However, very vigorous exercise (like training for a marathon) may often worsen RLS symptoms.”

For Sale by Prescription

Just because a therapy is non-pharmacological doesn’t necessarily mean it is available over-the-counter. Restiffic and Relaxis are two FDA-cleared prescription-only devices that RLS patients may find helpful.

Restiffic is a compressive foot wrap. The wrap applies pressure to targeted muscles in the foot, specifically the flexor hallucis brevis and abductor hallucis muscles that are innervated by the peripheral nerve, to reduce the symptoms of RLS. “We theorize that applying pressure to these muscles counteracts the nerve signals that are causing the RLS symptoms,” explains Bender, who is also president of medi USA’s CircAid Medical division of compression products. The device can be worn at night and will not interfere with the sleep of the patient or their partner, according to the manufacturer. Its compact size also makes it travel-friendly.

Patients with various medical conditions (such as poor circulation or peripheral vascular disease) or existing injuries (including bruises and sprains) should not use the product. As such, Bender suggests patients consult a physician to ensure other medical conditions do not conflict with the use of this product.

The Relaxis system is a prescription medical device designed for the treatment of primary RLS symptoms. Fred Burbank, MD, CEO of maker Sensory NeuroStimulation Inc, explains that the system consists of a digital controller and pad that provide vibration as a counterstimulus to RLS dysphoria at the time of an attack.

Relaxis RLS Device

A patient uses the controller to adjust the vibration of the Relaxis pad placed under the legs and lower thighs.

According to Burbank, Relaxis is appropriate for newly diagnosed patients who do not want to use drugs as well as patients who currently use RLS drugs and want to decrease their dosage or stop using their medications altogether. Also, those who are experiencing drug side effects or who need additional help getting a good night’s sleep may benefit. Patients who find vibration irritating should not use Relaxis. In clinical trials, reported adverse events (mild to moderate in severity) included leg cramping, tingling, soreness, pain, and motion sickness. After discontinuing device use, all adverse events resolved without intervention. No long-term side effects were observed.

“Limited RLS drug effectiveness and high RLS drug side effect rates demand a device alternative for RLS patients. Patient choice is central to good medicine,” Burbank says. “Because historically RLS has been treated with drugs, device treatments of RLS are a new concept to the medical community. The medical community will have to widen its understanding of RLS and accept medical device treatments that have passed the rigors of the FDA as legitimate alternatives to drug treatments.”

Electrical Stimulation

Transcutaneous electrical nerve stimulation (TENS) is the application of electric current through electrodes placed on the skin, usually for pain control, and the current is produced by a portable battery-operated device.4 TENS treatments are considered safe for patients and generally tolerated well, but there is little information on the effectiveness of TENS in decreasing symptoms associated with RLS.4 “TENS is the only form of electrical stimulation mentioned in connection with RLS. In theory, TENS provides counterstimulation to the brain, overriding the impulse to move,” Mitchell explains. “Just like with natural remedies, results vary; it might work for some, so I would recommend trying it out before choosing to take drugs.”

Other Non-Drug Treatments

According to Buchfuhrer, iron therapy can be very helpful when serum ferritin/iron levels are decreased, adding that he checks the level on every new RLS patient. A serum ferritin concentration lower than 45 to 50 mcg/L (ng/mL) has been linked with increased severity of RLS, and iron replacement is suggested if the serum ferritin level is lower than 75 mcg/L.5 Iron supplementation can be supplied orally or intravenously, and monitoring is important to avoid a rare but serious complication of iron overload in patients with hemochromatosis genes.5

Many authors mention temperature (such as hot baths) and tactile (such as massage) stimulation as potential treatment options, but there are not many scientific trials to confirm their efficacy. Massage can be effective as it has been shown to increase dopamine levels in urine by an average of 28% in different conditions,6 while another speculation on the working mechanism of massage is the counterstimulation it provides to the cerebral cortex.7 The application of hot or cold packs can also help relax the muscles in the legs.8

Mental activity, such as reading, card games, or computer work, has also been suggested to decrease RLS symptoms.2 “This is especially helpful on an airplane trip when the ‘fasten your seatbelt’ sign is on and the patient can’t move,” says Buchfuhrer.

Near-infrared light (NIR), which has been used in the treatment of neuropathy and wound healing, can also be used in RLS treatment. Treatment with a vasodilator, such as NIR-induced nitric oxide, could conceivably temporarily decrease symptoms.2

On the Horizon

Medi USA’s Bender says, “We expect that non-drug therapies will experience a steady growth over the coming years as awareness increases about these alternative options and as further clinical trials prove their efficacy. Though some patients and clinicians may currently feel more familiar with pharmaceuticals, the disadvantages of pharmaceutical treatment [may] outweigh the advantages for many.”

Koo says because tissue hypoxia and/or circulatory problems are a growing area of research, a device that addresses these problems may be helpful.

Also, combination therapies may be an area of future research. Mitchell says, “There has been no research assessing the possibility of an enhanced or additive effect when using several non-drug therapies in combination. Since the etiology of this condition is most likely multifaceted, it might need this kind of comprehensive treatment approach.” Additionally, Mitchell says exploring the cause of this condition may be essential in finding effective treatments. “The problem with the treatment of RLS-associated symptoms is the uncertainty about their origin,” Mitchell explains. “I expect to see advancements in finding the actual etiology/etiologies of this disease through research. This will then help us find new, or improve already existing, non-drug therapies.”

Buchfuhrer says future developments will likely include genetic testing and treatments, as well as a better understanding of iron and RLS physiology and iron treatment for RLS. He also says healthcare professionals and patients can expect to see different devices that will help decrease the RLS symptoms by providing different types of stimuli.

Bender says, “As a manufacturer of medical devices, our goal is to provide safe and effective treatment for our patients and to improve their lives. Pharmaceutical treatment has long been touted as the only medically proven treatment option for RLS, so it is important to raise awareness of non-drug treatment options that have been proven to be safe and effective by the FDA.”

Cassandra Perez is associate editor for Sleep Review. CONTACT cperez@allied360.com

References

1. Comparative Effectiveness of Treatments for Restless Legs Syndrome – Research Protocol | AHRQ Effective Health Care Program. Agency for Healthcare Research and Quality, 16 Dec. 2011. http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=897. Accessed 12 Sept 2016.

2. Mitchell UH. Nondrug-related aspect of treating Ekbom disease, formerly known as restless legs syndrome. Neuropsychiatr Dis Treat. 2011;7:251-7.

3. Aukerman M, Aukerman D, Bayard M, Tudiver F, Thorp L, Bailey B. Exercise and restless legs syndrome: a randomized controlled trial. J Am Board Fam Med. 2006;19:487–493.

4. Mitchell UH. Medical devices for restless legs syndrome—clinical utility of the Relaxis pad. Ther Clin Risk Manag. 2015;11:1789-94.

5. Tarsy D, Silber MH. Treatment of Restless Legs Syndrome/Willis-Ekbom Disease and Periodic Limb Movement Disorder in Adults. UpToDate, n.d. Web. 12 Sept 2016.

6. Field T. Massage therapy effects. Am Psychol. 1998;53(12):1270–81.

7. Melzack R, Wall P. Pain mechanisms: a new theory. Science. 1965;150:971–9.

8. Pietrangelo A. Best Treatments for Restless Leg Syndrome. Healthline, 2013. www.healthline.com/health/restless-leg-syndrome/treatments#Overview1. Accessed 12 Sept 2016.