![]() Factors that may lead to leg cramps attacks include hemodialysis, electrolyte imbalance, metabolic disorders, and congenital disorders ( 4). The medical history and physical examination are usually sufficient to differentiate nocturnal leg cramps from other conditions, such as restless legs syndrome, claudication, myositis, and peripheral neuropathy. Patients might wake up with pain during attacks, making it difficult to sleep for a short period. The gastrocnemius is commonly involved ( 1), lasting from a few seconds to a few minutes ( 2). Nocturnal leg cramps (NLCs) are spontaneous contractions of muscles. ![]() The findings of this RCT will encourage the studies of vitamin K2 in musculoskeletal disorders.Ĭlinical Trial Registration: identifier, NCT05547750. This randomized controlled trial (RCT) of rigorous methodological design will help to establish the effectiveness of vitamin K2 for the management of NLCs in older population. Our previous study has shown vitamin K2 was effective to reduce the frequency, severity, and duration of dialysis-related muscle cramps with a good safety profile. Two hundred patients will be needed, for this two-treatment parallel design study, to achieve a probability is 90% that the study will detect a treatment difference at a two-sided 0.04 significance level, if the difference between treatments is 3.6 (difference in means between treatment arms) NLC events.ĭiscussion: Nocturnal Leg Cramps (NLCs) are a common musculoskeletal disorder in the general population, but effective and safe interventions have not been established. The secondary outcomes include the severity and duration of NLCs in the vitamin K2 and placebo arms. The primary outcome is the difference in the mean number of NLCs per week in the vitamin K2 and placebo arms. Follow-up visits will be scheduled each week at the beginning of 4-week intervention, then participants will be visited semimonthly. Participants will be randomized to receive vitamin K2 or a similar-looking placebo for 8 weeks in a 1:1 ratio. Methods and analysis: This multicenter, randomized, double-blind, placebo-controlled clinical study will enroll older age (≥65-year-old) with two or more documented episodes of NLCs during 2 weeks of screening. Thus, the present study aims to investigate the effects of vitamin K2 for NLCs in a prospective randomized, double-blind, controlled trial. There is conflicting evidence regarding the efficacy of conventional interventions in preventing cramps. Because the precise pathophysiology of NCLs is unclear, different interventions have been proposed. Introduction: Nocturnal leg cramps (NLCs) are sudden contractions of the leg muscles, usually in the posterior calf muscles at night, affecting sleep quality. 3Department of Neurology, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, China.2School of Clinical Medicine, North Sichuan Medical College, Nanchong, Sichuan, China.1Department of Hematology, Chengdu Third People's Hospital, Chengdu, Sichuan, China.Ying Li 1,2 †, Rui Zhu 1,2 †, Li Wang 3 and Jing Tan 1 *
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