Evaluating the quality of life of patients with restless legs syndrome

Clin Ther. 2004 Jun;26(6):925-35. doi: 10.1016/s0149-2918(04)90136-1.


Background: The primary morbidities of restless legs syndrome (RLS) involve sleep loss, extreme discomfort, and disruption of normal activities. Although the condition is not life-threatening, assessing the disease burden and the impact of RLS on quality of life (QOL) is critical for evaluating treatment benefits.

Objective: The purpose of this study was to assess the impact of RLS on QOL.

Methods: In this subanalysis of a specific validation study, the SF-36 (Medical Outcomes Study 36-Item Short Form health survey) was administered to 85 patients with primary RLS who had been referred to a sleep-medicine clinic. The scores were compared with published norms for the general population (N = 2474).

Results: The majority (63.5%) of RLS patients were women; the mean (SD) age was 62.4 (14.0) years; 67.1% of patients experienced RLS symptoms almost daily. The RLS group, particularly patients with more severe RLS, reported significant deficits (10-40 points on 100-points scales) in physical functioning, bodily pain, role functioning, mental health, general health, and vitality compared with the general population. The RLS sample had significantly lower scores (worse QOL) on all 8 scales of the SF-36 compared with patients with hypertension (P<0.01); compared with patients with other cardiovascular conditions (ie, congestive heart failure, myocardial infarction within the past year, and angina), the RLS group had lower scores on 6 of the 8 scales. RLS patients had lower scores on 7 of 8 scales compared with diabetes patients, and on 4 of 8 scales compared with osteoarthritis patients.

Conclusions: Comparison of the SF-36 scores of patients with RLS and the normative general population suggests that the disorder has a significant impact on patient QOL.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.
  • Validation Study

MeSH terms

  • Adult
  • Age Distribution
  • Aged
  • Aged, 80 and over
  • Female
  • Humans
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Psychometrics / instrumentation*
  • Quality of Life / psychology*
  • Restless Legs Syndrome / complications
  • Restless Legs Syndrome / physiopathology
  • Restless Legs Syndrome / psychology*
  • Sex Distribution
  • Sickness Impact Profile*
  • Surveys and Questionnaires / standards*
  • United States