Cold therapy for restless legs syndrome
Evidence review
Overview
Many people with restless legs syndrome report that cooling the legs eases symptoms. In a German randomized pilot of 35 patients, 2 weeks of daily 3-minute whole-body cryotherapy at -76 F, given at 6 pm, was followed by improved RLS severity, quality of life and daytime sleepiness compared with each patient's baseline, while a milder 14 F chamber and local leg cryotherapy had smaller effects. The arms were small, the comparison was within groups, and cold-water immersion has not been studied in RLS.
Key findings
- -76 F chamber, 3 min daily for 2 weeks: IRLS improved vs baseline (p=0.009), RLS-QLI (p=0.006), ESS (p=0.020); not seen with a 14 F chamber (Happe 2016, n=35)
Every study we reviewed
1 found benefit
Each study was checked on PubMed. The colored edge shows the direction of the result. The research library lists 2 studies on restless legs syndrome, across all heat and cold therapies, including case reports and older work not graded here.
Whole body and local cryotherapy in restless legs syndrome: A randomized, single-blind, controlled parallel group pilot study.
Happe S et al. J Neurol Sci. 2016. PubMed 27772790 · DOI
- Who
- patients with idiopathic restless legs syndrome (28 women, mean age 60.9) with symptoms starting by 6 pm
- What
- whole-body cryotherapy chamber at -76 F (-60 C) (n=12) vs cold-air chamber at 14 F (-10 C) (n=12) vs local cryotherapy at 1 F (-17 C) (n=11), 3 min daily at 6 pm
- Protocol
- -76 °F · 3 min · 7/wk · 2 wk
- Measured
- International RLS Study Group severity scale (IRLS, primary); sleep, sleepiness, quality of life, PLM index
- Result
- At end of follow-up, only the -76 F group improved vs its own baseline in IRLS (p=0.009), RLS quality of life (p=0.006) and sleepiness (ESS p=0.020); local cryotherapy improved quality of life and sleep quality but not IRLS; the 14 F chamber only reduced the number of night-time waking phases. No serious side effects.
- Limitations
- pilot; about 12 per arm; within-group comparisons reported, not between-group; single-blind
Protocols used in the studies
Cold-air chamber at -76 F (-60 C) for 3 minutes daily at 6 pm for 2 weeks, with 4 weeks of follow-up. No cold-water immersion protocol has been studied.
What is still unknown
Adequately powered trials with between-group analysis; durability beyond 4 weeks; whether cold-water leg or whole-body immersion has similar effects; optimal timing and temperature.
Safety
Cautions for cold therapy in this condition
- No serious side effects were reported with chamber cryotherapy in RLS (PMID 27772790).
- See general cold safety entry for cardiovascular, Raynaud's and cold urticaria cautions.
For clinicians
Suggested rationale
In a small randomized pilot (Happe 2016), daily whole-body cryotherapy at -76 F for 2 weeks was followed by improved restless legs severity and quality of life compared with baseline, as an addition to standard treatment; the evidence is preliminary and does not extend to cold-water immersion.
Suggested wording only. The treating clinician decides whether it reflects their clinical judgment for this patient.
Typical ICD-10 codes: G25.81. Examples only; the clinician assigns the code.
What a letter of medical necessity should containWho can write it: physicians, NPs, PAs and others