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Original Research |

Pneumatic Compression Devices Are an Effective Therapy for Restless Legs Syndrome: A Prospective, Randomized, Double-Blinded, Sham-Controlled Trial

Christopher J. Lettieri, MD, FCCP*; Arn H. Eliasson, MD, FCCP
Author and Funding Information

*From Pulmonary, Critical Care, and Sleep Medicine, Walter Reed Army Medical Center, Washington, DC.

Correspondence to: Christopher J. Lettieri, MD, Pulmonary, Critical Care, and Sleep Medicine, Walter Reed Army Medical Center, 6900 Georgia Ave NW, Washington, DC 20307; e-mail: christopher.lettieri@us.army.mil

*Values are given as the mean ± SD, unless otherwise indicated.

*Values are given as No. (%), unless otherwise indicated. NA = not available.

*Values are given as the mean ± SD, unless otherwise indicated.

*Values are given as the mean ± SD, unless otherwise indicated.

*Values are given as the percentage of subjects in each randomization arm who reported any improvement in the measured variable.

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.

Aircast LLC (Summit, NJ) supplied the VenaFlow system pneumatic compression devices and matching sham devices for use in the study. Aircast LLC was not involved in this study or the preparation of this article.

The authors have reported to the ACCP that no significant conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).


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.

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.

Aircast LLC (Summit, NJ) supplied the VenaFlow system pneumatic compression devices and matching sham devices for use in the study. Aircast LLC was not involved in this study or the preparation of this article.

Aircast LLC (Summit, NJ) supplied the VenaFlow system pneumatic compression devices and matching sham devices for use in the study. Aircast LLC was not involved in this study or the preparation of this article.

The authors have reported to the ACCP that no significant conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

The authors have reported to the ACCP that no significant conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).


Chest. 2009;135(1):74-80. doi:10.1378/chest.08-1665
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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

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