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% versus 1%, respectively; p = 0.03; daytime function 21% versus 6%, respectively, p = 0.02; sleep quality 16% versus 8%, respectively, p = 0.05; emotional well-being 17% versus 10%, respectively, p = 0.15). Both Epworth sleepiness scale (6.5 +/- 4.0 versus 11.3 +/- 3.9, respectively, p = 0.04) and fatigue (4.1 +/- 2.1 versus 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.

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