Abstract and Introduction
Background: Pharmacotherapy for restless legs syndrome (RLS) may be ineffective or complicated by side effects. Uncontrolled series using pneumatic compression devices (PCDs) have been shown to reduce symptoms of RLS. We sought to assess the efficacy of PCDs as a nonpharmacologic treatment for RLS.
Methods: We performed a prospective, randomized, double-blinded, sham-controlled trial of individuals with RLS. Subjects wore a therapeutic or sham device prior to the usual onset of symptoms for a minimum of 1 h daily. Measures of severity of illness, quality of life, daytime sleepiness, and fatigue were compared at baseline and after 1 month of therapy.
Results: Thirty-five subjects were enrolled. Groups were similar at baseline. Therapeutic PCDs significantly improved all measured variables more than shams. Restless Legs Severity Score improved from 14.1 ± 3.9 to 8.4 ± 3.4 (p = 0.006) and Johns Hopkins Restless Legs Scale improved from 2.2 ± 0.5 to 1.2 ± 0.7 (p = 0.01). All quality of life domains improved more with therapeutic than sham devices (social function 14% vs 1%, respectively; p = 0.03; daytime function 21% vs 6%, respectively, p = 0.02; sleep quality 16% vs 8%, respectively, p = 0.05; emotional well-being 17% vs 10%, respectively, p = 0.15). Both Epworth sleepiness scale (6.5 ± 4.0 vs 11.3 ± 3.9, respectively, p = 0.04) and fatigue (4.1 ± 2.1 vs 6.9 ± 2.0, respectively, p = 0.01) improved more with therapeutic devices than sham devices. Complete relief occurred in one third of subjects using therapeutic and in no subjects using sham devices.
Conclusion: PCDs resulted in clinically significant improvements in symptoms of RLS in comparison to the use of sham devices and may be an effective adjunctive or alternative therapy for RLS.
Trial Registration: Clinicaltrials.gov Identifier: NCT00479531
Restless legs syndrome (RLS) is a common sensorimotor disorder manifested by unpleasant sensations in the limbs that occur at rest and produce an irresistible urge to move.[1,2,3,4,5,6,7,8] These sensations frequently produce discomfort and may cause significant impairments in quality of life.[2,3,4,7,8,9] RLS symptoms commonly delay sleep onset or disrupt sleep continuity, leading to excessive daytime sleepiness (EDS), fatigue, mood changes, social withdrawal,[2,3,4,5,6,7,8,9] eroding daytime function and sense of well-being.[4,5,6,7,8,9,10,11,12]
It is estimated that 10% of adults have RLS, with women affected twice as often as men.[2,4,5,6,7,8,9,10] Symptoms can occur at any age, and 12% of patients develop RLS before age 10.[3,7] Prevalence rises with increasing age and may affect 29% of subjects > 50 years old and 44% > 65 years old.[9,11]
Pharmacologic agents used in RLS include dopamine agonists, benzodiazepines, opioids, and anti-epileptics. However, success rates are highly variable, and all of these drugs can cause intolerable side effects.[7,9,12,13,14,15,16,17,18,19,20,21,22,23,24,25] Iron administration has been shown to improve or resolve symptoms of RLS.[24,25] However, iron therapy is not universally successful, and recurrences of symptoms may occur despite the achievement of elevated ferritin levels.[8,24,25] In view of the variable success rates and potential for side-effects, a reliable nonpharmacologic option would have advantages over current medical therapies.
Prior experience has shown that pneumatic compressive devices (PCDs) may improve symptoms associated with RLS. In a pilot study of nine patients with moderate to severe RLS, we found that PCDs improved symptoms in all patients. Complete resolution of symptoms occurred in one third of subjects, and partial relief occurred in two thirds. No patients reported lack of response or worsening of their RLS symptoms.
We sought to validate the findings of our prior pilot study in a prospective, randomized, sham-controlled trial. We hypothesized that PCDs can effectively reduce the severity of RLS, improve sleep, decrease EDS, and improve quality of life measures.
The opinions expressed herein are those of the authors and should not to be construed as official or as reflecting the policies of either the Department of the Army or the Department of Defense.
CHEST. 2009;135(1):74-80. © 2009 American College of Chest Physicians