Pneumatic Compression Devices Are an Effective Therapy for Restless Legs Syndrome: A Prospective, Randomized, Double-Blinded, Sham-Controlled Trial – Source: Chest, Nov 18, 2008

Introduction: Pharmacotherapy for restless legs syndrome may be ineffective or complicated by side effects. Uncontrolled series using pneumatic compression devices have been shown to reduce symptoms of restless legs syndrome.

We sought to assess the efficacy of pneumatic compression devices as a nonpharmacologic treatment for restless legs syndrome.

Methods: Prospective, randomized, double-blinded, sham-controlled trial of individuals with restless legs syndrome.

Subjects wore therapeutic or sham device prior to the usual onset of symptoms for a minimum of one hour daily.

Measures of severity of illness, quality of life, daytime sleepiness and fatigue were compared at baseline and after one month of therapy.

Results: Thirty-five subjects were enrolled. Groups were similar at baseline.

• Therapeutic pneumatic compression devices significantly improved all measured variables compared to 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%, p = 0.03; daytime function 21% vs 6%, p = 0.02; sleep quality 16% vs 8%, p = 0.05; emotional well-being 17% vs 10%, p = 0.15).

• Both Epworth Sleepiness Scale (6.5 +/- 4.0 vs 11.3 +/- 3.9, p = 0.04) and fatigue (4.1 +/- 2.1 vs 6.9 +/- 2.0, p = 0.01) were improved compared to sham devices.

Complete relief occurred in one-third of subjects using therapeutic and in no subjects using sham devices.

Conclusion: Pneumatic compression devices resulted in clinically significant improvements in symptoms of restless legs syndrome compared to sham devices and may be an effective adjunctive or alternative therapy for restless legs syndrome.

Source: Chest, Nov 18, 2008 (E-pub ahead of print). PMID: 19017878, by Lettieri CJ, Eliasson AH. Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, Walter Reed Army Medical Center, Washington DC; Department of Medicine, Uniformed Services University, Bethesda, Maryland. [E-mail:]

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