Abstract
BACKGROUND: Leg cramps are common among older adults and often lead to sleep disturbances and reduced quality of life. However, there is no consensus on how to treat this condition. This study aimed to evaluate the effectiveness of compression stockings in preventing leg cramps in individuals aged 50 to 85. METHODS: This study was a three-arm, parallel-group, partially blinded, randomized placebo-controlled trial conducted in Finland. Participants were recruited nationwide through online advertisements and primary care centers. Eligible individuals had experienced at least two leg cramps per week during the previous 4 weeks. Participants were randomized to receive either knee-high medical compression stockings, magnesium hydrochloride, or placebo pills, to be used daily for 4 weeks. The primary outcome was the change in leg cramp frequency at week 8. Secondary outcomes included the number of leg cramp-related nocturnal awakenings and the perceived pain intensity on an ordinal scale. RESULTS: A total of 121 participants were randomized, and 109 (90.1%) completed the trial. The primary outcome analysis included 114 participants. The mean age was 65.8 years (SD 7.8), and 87 (71.9%) were women. At baseline, the median number of weekly leg cramps was 4 (IQR 3-7). At week 8, the median weekly leg cramp frequency was 2 (IQR 1-2.5) in the compression stockings group, 3 (IQR 2-6) in the magnesium group, and 3 (IQR 2-5) in the placebo group. The baseline-adjusted mean difference in leg cramp frequency between the compression stockings and placebo group was -1.43 (95% CI -2.36 to -0.50; P = .001). No significant difference was observed between the magnesium and placebo groups, with an adjusted mean difference of -0.20 (95% CI -1.49 to 1.09; P = 0.929). Four participants discontinued compression stockings due to adverse reactions. No serious adverse events were reported. CONCLUSIONS: Among older adults, daily use of compression stockings was effective in reducing the frequency and pain intensity of leg cramps, as well as the number of nocturnal awakenings caused by them. TRIAL REGISTRATION: ClinicalTrials.gov NCT04694417. Registered on 4 January 2021.