Nonpharmacological Considerations and Treatment of Restless Legs Syndrome

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Chapter 30 Nonpharmacological Considerations and Treatment of Restless Legs Syndrome

The nonpharmacological treatment of restless legs syndrome (RLS) should be an essential part of an integrated approach to treating this disorder. For many RLS patients, these treatments can be as effective as medications. Some RLS patients may not need any drug therapy once appropriate nonpharmacological measures have been instituted, whereas others may be able to reduce their medications significantly. This is very important, because many of the medications used to successfully treat RLS symptoms cause side effects, such as sedation, which may limit their daytime use, and these drugs also may cause addiction or tolerance. A combined drug and nondrug therapeutic plan has the best chance of long-term success with the least amount of side effects.

As with any chronic disease that affects a large percentage of the population, there are many different treatment strategies that have been developed. RLS patients who have mild or intermittent symptoms often do not seek medical care and are likely to develop treatments on their own after much trial and error. Most often, these treatments include nondrug therapies. Nondrug therapies comprise the largest group of treatments for this disorder, but most of these remedies are anecdotal and often not reproducible among other RLS sufferers. These nonpharmacological therapies are not often reported in the medical literature or studied in a scientific manner. Indeed, due to the difficult nature of performing double-blinded controlled studies with these treatments, as yet, few, if any, such reports exist in the medical literature. This chapter will cover most of the nonpharmacological therapies that have some support in the medical literature and many of the anecdotal ones that seem to work for a significant percentage of RLS patients.

Although RLS and periodic limb movements during sleep (PLMS) are two distinct disorders, it is believed that they occur from similar mechanisms. Most of the treatments that help one of the disorders help the other. This chapter reviews the treatments of both of these conditions. In much of the medical literature, studies address one of the two disorders and assume that the other will be affected one similarly.

To properly treat RLS, the physician and patient must work together as a team. Physicians must educate their patients about lifestyle changes, proper nutrition, medications that must be avoided, and other measures they can use when their medications are not helping or cannot be taken. Patients should be encouraged to learn as much as they can about these nonpharmacological measures, keep a medical alert card that lists the medications that should be avoided (available on the Internet), and join one of the many RLS support groups listed by the Restless Legs Syndrome Foundation (www.rls.org). The information in this chapter is essential for the physician to direct RLS patients on how to manage this often disabling disorder and complements the use of the various pharmacological treatments.

Lifestyle Changes

Sleep Hygiene and Daytime Schedule

One of the most frequently cited treatments for RLS in review articles is proper sleep hygiene.¹^–³ This recommendation stems from the general treatment of insomnia where sleep hygiene is very effective. RLS symptoms and PLMS follow a circadian rhythm, usually peaking between midnight and 4 A.M. and then decreasing to a minimum between 9 A.M. and 1 P.M.^4,⁵ Many RLS patients report that they take advantage of this phenomenon by delaying their bedtime by several hours, remaining active during the time when their worsening RLS symptoms would interfere with falling asleep. Getting enough sleep is important, as it has been noted that RLS symptoms and PLMS worsen with sleep deprivation and possibly fatigue.^4,⁵

RLS patients can schedule their daytime activities so they do not conflict as much with the circadian worsening of symptoms. Movies can be viewed as matinees rather than in the evening, airplane flights can be booked to leave in the morning, and reading a book or the newspaper will be easier in the morning. Activities that require walking, such as housework or exercise, may help relieve RLS symptoms if delayed until later in the day. With a bit of planning, many situations that would worsen RLS or require medication can be avoided.

Hormonal Considerations

Very commonly, female RLS sufferers notice that RLS symptoms are exacerbated a few days before menses and improve at the end of menses. In addition to this obvious hormonal influence on RLS, menopause seems to affect RLS, making it better or worse. Female RLS patients can adjust their activities during times of worsening or make sure they employ adequate extra measures for these cyclic fluctuations. Some have reported that starting, stopping, or changing the dose of hormonal medications has been helpful, and this may be worth discussing with their physicians.

Anxiety-Provoking Situations

RLS symptoms will at times wax and wane, and without checking into what is happening to your patient, it may seem obscure as to why they are worsening. Stress and the resultant anxiety it provokes often exacerbate RLS symptoms in an otherwise controlled patient. Controlling this anxiety by means such as counseling, changing to a less stressful job, adjusting lifestyle, or prescribing medication may be appropriate to improve RLS symptoms. Care should be taken not to use the anti-anxiety medications listed here, which worsen RLS.

Patients often describe anxiety and panic resulting from their RLS symptoms, especially when they occur at unexpected times. Thus, educating and preparing RLS patients on how to deal with these situations are extremely important and may help stop RLS episodes from spiraling out of control.

Patient-Generated Treatments

Situations will arise when medications do not help RLS symptoms or when medications are unavailable or cannot be taken. Other measures will then be necessary to combat the extremely irritating RLS symptoms. Self-help actions may be essential to help RLS patients get through these very trying situations. RLS patients should be ready to institute these procedures as quickly as possible, because once RLS symptoms become active, they tend to worsen rapidly and then are much more difficult to control. Preventing these symptoms from occurring is generally vastly easier than relieving them. In addition, these worsening RLS symptoms tend to create anxiety and the resulting panic reaction may further limit the patient’s ability to control the symptoms. It is thus very important that patients be aware of the techniques detailed in this chapter so that they can try them out and have the ones that work for them ready to use when necessary. After many years of suffering, it is not unusual to see RLS patients learn new helpful techniques from other RLS patients by reading RLS newsletters or participating in Internet discussion groups and local support groups. There is now a large network of support groups for RLS, and patients should be encouraged participate.

Activities

There are many activities that may alleviate RLS symptoms (see the RLS rebel Website for suggestions, http://members.cox.net/gunzel/index.html).⁶ The simplest activity is to start walking immediately. Walking will almost always relieve symptoms at least temporarily. Unfortunately, there are many situations when walking is not feasible or is inappropriate. Some of the commonest methods noted by many RLS sufferers are performing mentally engrossing activities, such as playing video or computer games, reading an interesting book, playing a musical instrument, and doing needlepoint or crossword puzzles. This is especially helpful when patients are confined, such as when traveling on airplanes or by medical conditions that preclude movement when employing other physical measures may be difficult. Stretching exercises, including yoga, often relieve RLS symptoms temporarily. There is a wide range of stretches but most will apply tension to the calf or thigh muscles. Standing on tip-toe or holding a half deep knee bend until fatigued are other examples or exercises that help. These stretches will often help mild to moderate RLS patients reduce symptoms enough so that they can fall asleep. Exercise may benefit RLS when performed at a mild to moderate level.⁷ Higher levels of strenuous exercise will usually exacerbate RLS symptoms even if done early in the day. Many RLS patients have been frustrated when they have to curtail their level of exercise.

Physical Interventions to Legs

One of the first measures that RLS patients will try when they cannot fall asleep is to rub their legs or get their partner to massage them. This will often give temporary relief, sometimes long enough to permit sleep. The amount of pressure needed seems to vary considerably, with some reporting that they need their legs pounded whereas others prefer milder massage. Some have even purchased electric vibrators/massagers, which may be helpful despite the lack of benefit demonstrated by the one study that used vibration therapy.⁸ Leg wraps, using Ace bandages, are sometimes helpful, as are surgical support hose. Even other physical measures such as having the feet tickled can bring relief of symptoms for many hours. Baths and showers are also very often used measures. Most people prefer hot water, while some prefer cold water or even alternating hot and cold water. Others have used heating pads or electric blankets. A few patients describe using ice packs for several minutes before bed. There are others who must keep their legs free of bedding or other physical contact for relief and may find that massage or other physical contact worsens their RLS symptoms.

Sexual Stimulation

There are many anecdotal reports of sexual stimulation and, especially orgasm, helping RLS symptoms. This appears to be more prevalent among female RLS patients, who will often find that when they are not able to fall asleep due to RLS symptoms, having an orgasm may be the only measure that will alleviate their symptoms and permit them to fall asleep.

Nutritional Considerations

Proper nutrition is often mentioned as beneficial for decreasing RLS symptoms.² Despite the fact that there are no studies investigating the effects of diets on RLS or PLMS, this is one of the most frequently described interventions by RLS patients. A very common complaint is that ice cream (all flavors) seems to exacerbate RLS. A small percentage of RLS patients have found that decreasing carbohydrates or gluten and wheat (especially white flour) in their diet may be helpful.

In addition to the many anecdotal complaints from RLS patients, there is discussion in the medical literature about the benefits of avoiding caffeine, alcohol, and tobacco.^1,^3,⁹

Caffeine

Abstinence from caffeine is considered essential, based on a 1978 clinical series study ¹⁰ that reported on 10 patients who had complete relief by withdrawing from caffeine-containing beverages, food and medications, and other xanthine-containing products. Most of the patients got rapid relief from their RLS symptoms within the first few days of abstinence. Diazepam was used in five of the patients to help with anxiety and withdrawal problems, with possibly three of them using it long term. Two of the patients reported recurrence of symptoms with the resumption of caffeine consumption. The author concluded that caffeine was the cause of RLS and that eliminating caffeine would resolve its symptoms. Although most RLS patients will note worsening of their symptoms with caffeine, there are no other reports in the literature demonstrating complete resolution of RLS complaints following the cessation of caffeine intake. It may often be very difficult to avoid caffeine and other xanthines because they are present in many foods and prescription and nonprescription drugs. RLS patients should carefully examine the foods and drugs they are taking to ensure that caffeine is not present. One study looking at the risk factors of RLS in depressed or anxious patients maintained on tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRIs) found that the regular use of nonopioid analgesics (frequently combined with caffeine) appeared to be the major risk factor for RLS rather than their use of antidepressants.¹¹

Alcohol

Alcohol leads to disturbed sleep, with even a single low dose resulting in increased sleep fragmentation and number of awakenings in non–alcohol–dependent adults.¹² RLS patients will often seek hypnotics at bedtime due to the insomnia caused by their symptoms, and alcohol is a common choice due to its easy availability. Alcohol intake at bedtime shortens the time to onset of sleep but increases wakefulness in the second half of the night,¹³ which may then be further exacerbated by RLS symptoms. There are no studies on the effects of alcohol on RLS, but its effects on PLMS have been investigated. One study found a reduction in the arousals associated with PLMS in four patients but little effect on the overall frequency of the leg movements after an evening dose of alcohol.¹⁴ Aldrich and Shipley¹⁵ studied the effects of mild intake of alcohol (less than two drinks per day) compared with heavy drinkers (two or more drinks per day) using a large group of patients presenting to a sleep disorders clinic. They found that a clinically significant frequency of PLMS (more than 20 per hour) is more likely to occur in the subjects who drink two or more alcoholic beverages per day than in those who do not. Subjects did not drink the night of the sleep study. Interestingly, they found that women who drink two or more drinks per day are more likely to have a primary diagnosis of PLMS or RLS. It is not clear from this study whether the heavier alcohol use is causing more PLMS and RLS or if these patients use more alcohol to help them cope with their existing disorders. However, a more recent epidemiologic study using telephone interviews on 1803 adults in Kentucky found that RLS was associated with low alcohol consumption.¹⁶

Tobacco

The association of cigarette smoking and RLS remains uncertain. An early case study report describes a 70-year-old woman who had been a smoker for 50 years and then stopped due to underlying lung disease.¹⁷ Her RLS symptoms, which had been severe and refractory to all previous therapy, completely disappeared 1 month after smoking cessation. This relationship of RLS and smoking was not found in a 1997 epidemiologic study on 2019 Canadian adults using survey questions about RLS symptoms and smoking (included as a smoker if they smoked in the past 2 weeks).¹⁸ In addition, they studied a group of RLS/PLMD smokers (at least one cigarette per day) and nonsmokers in a sleep laboratory. No significant differences between these groups were found for sleep and motor variables. A major limitation in this study is that the measures of smoking did not take into account nicotine dose, duration of habit, or degree of dependence. An association with smoking (more than one pack per day) was found in the 2000 epidemiologic study noted earlier¹⁶ and another 2004 study that found ex-smokers and current smokers had higher risks for RLS.¹⁹

Minerals and Vitamins

Patients often use minerals and vitamins to treat RLS because they are readily available and are often recommended by friends and homeopathic practitioners. There are many anecdotal reports of benefits from calcium, magnesium, potassium, zinc, vitamins A, B, C, D, and E, niacin, folic acid, and iron. The evidence for iron is considerable and is covered in another section of this book (see Chapter 34). However, there is little evidence for all the others, except for folic acid and magnesium. There is one case report study that examined leg cramps occurring in patients treated in a dermatologic study with vitamin E.²⁰ In their series of leg cramp patients who improved with treatment, they have two patients with RLS symptoms for 10 to 20 years who obtained complete relief with 200 to 300 IU vitamin E/day.

An open-label pilot study examined the effect of oral magnesium (12.4 mmol each evening for 4 to 6 weeks) on 10 patients (with normal serum magnesium levels) with mild to moderate RLS and PLMD.²¹ There was a significant decrease in PLMS arousals from 17 per hour to 7 per hour and in the responders (five patients with subjective improvement in RLS and two with PLMS-related insomnia), there was a marked decrease of PLMS with arousals from 17.9 per hour to 3.9 per hour. In a case report, a woman with RLS of pregnancy responded to intravenous magnesium given to forestall preterm labor, which led to complete relief of RLS symptoms.²²

An early study in 1977 found the prevalence of RLS in pregnant women taking vitamin supplements with folate was only 9% compared with 80% of those taking vitamins without folate.²³ A more recent study in 2001 examined 30 women prospectively throughout their pregnancies and found that RLS symptoms, which occurred in 23%, were not significantly correlated with hemoglobin, iron or vitamin B₁₂ levels, but rather with lower folate levels.²⁴ Tunc and colleagues²⁵ found that women who developed RLS were less likely to receive iron and folate supplementation during pregnancy. When women received adequate iron and folate supplements, it appeared that those with more chronic decreased iron stores were more likely to develop RLS.²⁶

Herbal Remedies

Herbal remedies are also commonly used by RLS patients with many anecdotal reports of benefit from kava kava, St. John’s wort, butcher’s broom, amino acids such as L-tyrosine, valerian root, pycnogenol (revenol), horse chestnut, MSM (methylsulfonyl methane), quinine, brewer’s yeast, lecithin, coenzyme Q10, horse chestnut seed (Aesculus hippocastum), and grape seed extract. None of these has been studied and thus they cannot be recommended for use in RLS.

Medications to Avoid

There are many different over-the-counter and prescription medications that can worsen RLS. It is thought that worsening of RLS may occur by blocking dopaminergic pathways, which has been demonstrated to occur with the dopamine receptor antagonist pimozide.²⁷ Many of the drugs discussed later do have obvious dopamine-blocking properties, but several others do not. The reasons for their negative actions on RLS remain to be determined.

Antihistamines

Although there are no studies in the literature evaluating how antihistamines affect RLS, they are probably the most commonly used drug that worsens RLS. Many RLS patients will note that their symptoms worsen with antihistamines. It is often difficult for them to avoid antihistamines because they are combined with other drugs in many cold and cough remedies. In addition, RLS patients often purchase over-the-counter sleeping pills to help overcome the insomnia caused by their bedtime symptoms. All those sleeping aids contain antihistamines (diphenhydramine, doxylamine, etc.), which will increase RLS symptoms and worsen insomnia. The newer second-generation H₁ blockers (loratadine, fexofenadine, desloratadine) do not cross the blood-brain barrier and are less likely to exacerbate RLS symptoms. These are far preferred for treating allergic problems in RLS patients.

Antinausea and Antiemetic Drugs

Antinausea drugs that act on the dopamine system often worsen RLS symptoms. There is only one report on the commonly used antiemetic prochlorperazine, which found that 44% of emergency department patients who received this medication developed, within 1 hour, symptoms suggestive of RLS (called akathisia in this study).²⁸ Other antinausea drugs that worsen RLS include trimethobenzamide, promethazine, hydroxyzine, and meclizine. The antinausea drug metaclopramide, a dopamine blocker, often worsens RLS symptoms. However, there is only one report that found a nonsignificant trend of it worsening PLMS but no effect on RLS symptoms. RLS patients who need an antinausea drug should take domperidone (available only in Canada and Mexico), a drug that does not cross the blood-brain barrier and does not affect RLS.²⁹ There are two newer drugs, granisetron hydrochloride and ondansetron hydrochloride, that are selective serotonin₃ receptor antagonists that do not bind to the dopamine receptors.³⁰ RLS patients have reported that these newer drugs work very well without exacerbating RLS, but the medications are indicated for preventing nausea from chemotherapy and are still very expensive.

Antidepressant Medications

Antidepressant drugs generally worsen RLS symptoms. The older tricyclic antidepressants are the most common group to affect RLS and PLMS. This effect was first examined in 1987 by Garvey, who found 30 of 98 depressed patients treated with various tricyclic antidepressants reported that they developed mild leg myoclonic jerks in the evening.³¹ Nine other patients complained of moderate to severe myoclonus but only two subjects reported PLMS during sleep (the others had jaw or arm jerks during the daytime).

Currently, the most commonly prescribed antidepressants are the SSRIs, and they also tend to worsen RLS and PLMS. Dorsey and colleagues,³² using polysomnographic (PSG) evaluations, studied fluoxetine in young (average age, 24 years) depressed patients who complained of sleep maintenance insomnia or morning fatigue. The fluoxetine-treated group had mild PLMS (PLM index of 15 per hour or less) in 44% of subjects compared with no PLMS noted in the control depressed group. Paroxetine was found to exacerbate RLS in a case report study of a 33-year-old man who was given the drug and after a week developed marked worsening of previously mild RLS symptoms.³³ Despite improvement in his depression, he stopped the paroxetine and the RLS symptoms resolved. He was then put back on paroxetine, which resulted in his RLS symptoms returning but was then treated for RLS with lormetacepam in the evening. After 3 months, the paroxetine was discontinued and his RLS symptoms resolved again. Sertraline worsening RLS was first reported in a case report of a 71-year-old man who had mild intermittent RLS, which became severe within 1 week on the drug.³⁴ Due to marked worsening of his RLS symptoms, he discontinued the drug and reported complete resolution of these symptoms within 3 days. There is one retrospective study that reviewed 113 consecutive patients attending a hospital medical clinic who had been prescribed SSRIs (sertraline, paroxetine, or fluoxetine) and found that most patients who had preexisting RLS symptoms (65% of the 113 SSRI patients) experienced improvement with their treatment.³⁵ In this study, there was a reduction in leg restlessness in 58%, complete resolution in 12%, worsening in 12%, and no change in 30%. The results of this study may be questioned due to the retrospective nature of the study, which was unblinded and derived from self-selected questionnaire respondents, which yielded a very high 65% of RLS patients from this SSRI group. There is only one study abstract in the literature supporting SSRIs suppressing PLMS.³⁶ This study retrospectively evaluated a group of 70 patients sent for sleep apnea studies. They compared a group of 35 patients taking SSRI medications with 35 subjects who were not and found that PLMS were significantly fewer (22.8 movements per hour) in the SSRI group than in the control group (36.4 movements per hour).

The newer antidepressant venlafaxine, an inhibitor of reuptake of both serotonin and norepinephrine, was found to cause PLMS (more than 25 per hour) in 75% of eight normal volunteers treated with the drug and compared with baseline by PSG evaluations.³⁷ Two of the eight patients developed symptoms of RLS, which continued for about 1 week after the drug was discontinued. There are four case reports of mirtazapine worsening RLS. The first reports on a 33-year-old man who developed RLS symptoms in the evening 30 minutes after his dose of mirtazapine 15 mg that he had taken for 1 week to treat his depression.³⁸ His RLS symptoms resolved after a week off the drug. The second presents a 56-year-old Korean woman who developed RLS symptoms after 5 days on mirtazapine 15 mg that persisted until she was changed to paroxetine.³⁹ The third case describes a 78-year-old woman with a personal and family history of RLS who had worsening of her RLS symptoms when treated with mirtazapine for her depression and then improved when the drug was withdrawn.⁴⁰ The last case reports on a 45-year-old man with depression who did not have a problem with mirtazapine at 15 mg but developed RLS symptoms at night and 41 PLMS per hour on PSG after being increased to 30 mg.⁴¹ His symptoms were treated with clonazepam and he was maintained on the drug.

The mechanism by which these antidepressant drugs worsen RLS or PLMD is not understood. They do not act on the dopamine system like many of the other drugs that worsen RLS. What is more puzzling is that a significant minority of patients report improvement of their RLS symptoms on these drugs. Anxiety tends to worsen RLS, so it may be that by reducing anxiety, these drugs decrease RLS symptoms. The reduction in anxiety will also enable RLS patients to fall asleep more readily, thus reducing the bedtime RLS problem. Many of the older tricyclic antidepressants have significant sedative properties which may further help to promote sleep.

If the patient finds that the antidepressant treatment cannot be changed and is essential for the patient’s well-being, then the drug can be continued and RLS symptoms treated with currently recommended RLS medications. The other option for RLS patients not tolerating their antidepressants is to change to bupropion, which does not generally worsen RLS or PLMS. This drug has the unique theoretical advantage of possessing mild dopaminergic effects.⁴² In fact, Nofzinger and associates⁴³ demonstrated that five depressed patients who had PLMS on PSG had significant reduction in their PLMS (14.9 per hour to 9.1 per hour) and a nonsignificant trend for reduction in their PLM arousals (90 to 33). Trazodone may be another alternative choice, as most RLS patients do not worsen with this medication, although there is one case report of severe myoclonic jerking of the upper extremities in a female after 5 weeks on this drug.⁴⁴ Another study compared PLMS in six depressed patients on and off trazodone.⁴⁵ They found that PLMS averaged 66 per hour off trazodone, whereas only 36 per hour occurred when off the drug.

Neuroleptic Medications

The neuroleptic medications have also been problematic when used by RLS patients as they decrease dopamine neurotransmission.⁴⁶ In fact, the older neuroleptics such as chlorpromazine are similar to the antinausea drugs and have been used for that purpose. The neuroleptics are known to produce akathisia, a condition that shares many clinical features with RLS.⁴⁷ Staedt and coworkers⁴⁸ studied 10 schizophrenic patients on chronic chlorpromazine therapy with PSG evaluations and found that all of them had much higher than expected PLMS and PLM microarousals. There was no control group in this study but the PLMS were much higher than expected. Olanzapine has also been shown to cause RLS and PLMS in a case report on a 41-year-old schizophrenic patient.⁴⁹ The patient’s RLS symptoms completely resolved immediately after he refused to take the medication any longer. PLMS and PLM arousals were higher as examined by PSG when on olanzapine and then off the drug. Another case report study examined a 31-year-old schizophrenic patient who developed typical symptoms of RLS and PLMS on PSG testing during treatment with risperidone (after being switched from clozapine).⁵⁰ The patient was switched to haloperidol and the RLS symptoms persisted but resolved when he was changed to quetiapine (including normalization of PLMS from 12.6 per hour to 1.5 per hour). Lithium has been implicated in causing RLS in one case report where RLS symptoms occurred at a high dose of the drug (1000 mg/day) and resolved permanently with a decrease in dosage (400 mg/day).⁵¹

Different results were noted in a study of 243 RLS patients who sought help for anxiety and/or depression and were treated with an antidepressant (tricyclics and/or SSRIs) for at least 6 months.¹¹ The researchers found a higher-than-expected incidence of RLS in their patients of 27% that was due to the subject’s use of caffeine-containing nonopioid analgesics rather than from the use of antidepressants or neuroleptics. They concluded that antidepressants and neuroleptics are not responsible for worsening RLS. This study’s methods have been criticized in a review by Berger, who did not think that the study’s conclusions were valid.⁵²

Other Treatments Still Under Investigation

Varicose Vein Treatments

Kanter ⁵³ screened 1379 patients, who presented at a vein treatment center, for RLS and found that 22% of them had this disorder. One hundred thirteen of these patients with RLS (36%) agreed to have sclerotherapy. Of the 113 patients, 111 (98%) reported relief from their RLS symptoms. Relief was defined as either complete resolution or sustained marked improvement of symptoms. Forty percent responded to one treatment and 78% to two treatments. At 2 years, 28% (12 of 43) who were available for follow-up had recurrences of their RLS symptoms. Kanter thought that further sclerotherapy would result in improvement of these recurrences. The subjects all had Doppler ultrasound examinations of their leg veins, and those with reflux in any saphenous trunk were classified as Doppler positive whereas those without were Doppler negative. The Doppler negative group represented 61% of all the patients who were screened and had RLS and 57% of the patients who elected to have sclerotherapy. These Doppler negative patients do not have obvious large rope-like varicose veins and might easily not be identified by primary care physicians. At the end of his article, Kanter indicates that a multicenter study using the RLS rating scale and PSG evaluations before and after sclerotherapy was in progress but no further studies have been published replicating his results. A different viewpoint on RLS and varicose veins is presented in a large study on 1566 patients in Edinburgh, Scotland.⁵⁴ RLS and other leg symptoms were assessed by a self-administered questionnaire and the subjects’ legs were examined visually to determine if varicose veins were present. The study found that RLS was no more prevalent in subjects with or without varicose veins. It is thus difficult to recommend sclerotherapy or other varicose vein treatment for RLS at this time. There are many anecdotal reports of surgical support hose helping RLS symptoms, but mechanism of this effect may have nothing to do with the treatment of varicose veins.

Mechanical Treatments

Although counterstimulation such as massage or striking the legs has been found by patients to relieve RLS sensations, there is very little in the literature concerning such mechanical treatments. An early study done in 1984 examined the effect of a battery-operated mechanical vibrator applied to one sural region for at least 15 minutes at bedtime for 1 week after a week on clonazepam 1 mg daily.⁸ Clonazepam helped the RLS patients but there was no significant effect from vibration therapy. An unblinded study of external counterpulsation found some benefit,⁵⁵ but the benefit could not be confirmed in a subsequent parallel double-blind study.⁵⁶ However, the issue may still be open because another open study subsequently published found benefit with sequential compression devices.⁵⁷ There is also a case report of a lumbar corset producing RLS relief.⁵⁸

Neuromuscular Stimulation Treatment

A pilot study done in 1991 examined eight patients with PSG-proved PLMS and sleep fragmentation using the EMS-250 Neuromuscular Stimulator applied for 30 minutes before bedtime to dorsiflexors of the feet and toes of both lower extremities to obtain a muscle contraction resulting in extension of the foot and toes.^55,⁵⁹ PLMS were reduced from 44.6 per hour to 14 per hour and PLM arousals from 28.9 per hour to 7.2 per hour. Indices of sleep did not change. The authors recommended more extensive controlled studies of this treatment, but no further studies have duplicated these results.

Biofeedback Therapy

Thermal biofeedback therapy was first studied on one subject who had been found to have PLMS and who complained of cold feet.⁶⁰ The authors, after hearing many anecdotal reports of cold feet from patients with PLMS, conducted a survey on 84 older patients (over age 65) with proved PLMS and found that 36% complained about cold feet. They then studied one of the patients with thermal biofeedback. A Cyborg Thermal J42 biofeedback unit was used with a thermistor attached to the ventral surface of the right big toe. Visual and audio feedback was monitored by the subject in 30-minute training sessions with an attempt to reach a criterion temperature of 95° F. The subject had 25 training sessions and increased his foot temperature by 8.0° F, reaching the criterion temperature of 95° F only during the final minute of the post-baseline no-feedback session. Two PSG studies were done before and after the course of thermal biofeedback therapy with the mean PLM index decreasing from 61.7 to 3.6. These findings were not duplicated in thermal biofeedback performed on seven subjects with significant PLMS (average PLMS per hour of 66) and could not find any improvement of PLMS or quality of sleep as judged by PSG evaluation despite effective increases in hand and foot temperatures.⁶¹ Another case study on a 49-year-old woman with PLMS and cold feet showed an increase in the PLM index (from an average of 86 per hour to 144 per hour based on two PSG studies) after successfully completing a 12-week course of thermal biofeedback therapy.⁶²

Cognitive-Behavioral Therapy

Edinger and colleagues ⁶³ performed a pilot study comparing clonazepam with cognitive-behavioral therapy (CBT) for treating sleep disturbances among PLMD patients. The CBT consisted of sleep education and a combination of stimulus control and sleep restriction. Two groups of eight subjects with PLMS were randomly assigned to either clonazepam or CBT for 4 weeks. In the CBT group, there were no significant differences in the PLM index before and after treatment but there was a 20% decrease in the PLM arousal index compared with an 18% and 44% decrease, respectively, for clonazepam. Both treatments equally improved sleep, but only CBT decreased daytime napping. Further studies would be necessary to recommend this therapy for PLMD.

Acupuncture and Acupressure

There is only one case report in the medical literature discussing the effect of acupuncture on RLS.⁶⁴ The author presents the case of a 55-year-old German engineer with symptoms that are very suggestive of RLS. Scalp and body acupuncture treatments were applied to the points along the gallbladder channel of the affected limb for 10 minutes twice daily. After five treatments, the symptoms were completely resolved but then they returned. He was then treated for 10 more treatments with complete relief of symptoms. Five more treatments were given for consolidation, and at 3-month follow-up, the patient was symptom free. Acupuncture has not made much impact on RLS in the Western world, because very few RLS patients have reported benefitting from this treatment.