Whole body and local cryotherapy in restless legs syndrome: A randomized, single-blind, controlled parallel group pilot study

Published:September 08, 2016DOI:


      • Patients with restless legs syndrome often experience relief by cold.
      • Cold chamber treatment (−60 °C) resulted in symptom relief in these patients.
      • Cryotherapy might be used as an additional treatment option in restless legs syndrome.



      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.

      Patients and methods

      35 patients (28 women, 60.9 ± 12.5 years) with idiopathic RLS and symptoms starting not later than 6 pm 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 6 pm 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.


      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.


      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.


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