title: Whole body and local cryotherapy in restless legs syndrome: A randomized, single-blind, controlled parallel group pilot study.
abstract: OBJECTIVE
  Treatment of restless legs syndrome (RLS) is primarily based on drugs. Since many patients report improvement of symptoms due to cooling their legs, we examined the efficacy of cryotherapy in RLS.
  
  
  METHODS
  35 patients (28 women, 60.9±12.5years) with idiopathic RLS and symptoms starting not later than 6pm were randomized into three groups: cold air chamber at -60°C (n=12); cold air chamber at -10°C (n=12); local cryotherapy at -17°C (n=11). After a two week baseline, the different therapies were applied three minutes daily at 6pm over two weeks, followed by a four week observation period. The patients completed several questionnaires regarding RLS symptoms, sleep, and quality of life on a weekly basis (IRLS, ESS), VAS and sleep/morning protocol were completed daily, MOSS/RLS-QLI were completed once in each period. Additionally, the PLM index was measured by a mobile device at the end of baseline, intervention, and follow-up. The IRLS score was chosen as primary efficacy parameter.
  
  
  RESULTS
  At the end of follow-up, significant improvement of RLS symptoms and quality of life could be observed only in the -60°C group as compared to baseline (IRLS: p=0.009; RLS-QLI: p=0.006; ESS: p=0.020). Local cryotherapy led to improvement in quality of life (VAS4: p=0.028; RLS-QLI: p=0.014) and sleep quality (MOSS: p=0.020; MOSS2: p=0.022) but not in IRLS and ESS. In the -10°C group, the only significant effect was shortening of number of wake phases per night. Serious side-effects were not reported.
  
  
  CONCLUSIONS
  Whole body cryotherapy at -60°C and, to a less extent, local cryotherapy seem to be a treatment option for RLS in addition to conventional pharmacological treatment. However, the exact mode of cryotherapy needs to be established.
authors: Department of Neurology, Klinik Maria Frieden, Telgte, Germany; Institute of Clinical Neurophysiology, Klinikum Bremen-Ost/University of Göttingen, Germany.
authors: Svenja
authors: S
authors: Happe
authors: Krankenhaus Lindenbrunn, Department of Neurology, Germany. Electronic address: everss@uni-muenster.de.
authors: Stefan
authors: S
authors: Evers
authors: Department of Neurology, Klinik Maria Frieden, Telgte, Germany; Institute of Clinical Neurophysiology, Klinikum Bremen-Ost/University of Göttingen, Germany.
authors: Christian
authors: C
authors: Thiedemann
authors: Institute of Clinical Neurophysiology, Klinikum Bremen-Ost/University of Göttingen, Germany.
authors: Sabine
authors: S
authors: Bunten
authors: Institute of Physical Medicine and Rehabilitation, Klinikum Bremen-Ost/University of Göttingen, Germany.
authors: Rudolf
authors: R
authors: Siegert
mesh_terms: D017679:Cryotherapy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011788:Quality of Life; D012148:Restless Legs Syndrome / Q000628:therapy*; D012720:Severity of Illness Index; D016037:Single-Blind Method; D012890:Sleep; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: Cold chamber; Coldness; Cryotherapy; Restless legs syndrome