Dataset Information

Managing nocturnal leg cramps--calf-stretching exercises and cessation of quinine treatment: a factorial randomised controlled trial.

ABSTRACT:

Background

Quinine is a common treatment for nocturnal leg cramps but has potential side effects. An uncontrolled study suggested that calf-stretching exercises could prevent nocturnal leg cramps (night cramps) but these findings have never been confirmed.

Aim

To assess the effect of calf-stretching exercises and cessation of quinine treatment for patients with night cramps taking quinine.

Design of study

Randomised controlled trial.

Setting

Twenty-eight general practices in southern England.

Method

One hundred and ninety-one patients prescribed quinine for night cramps were randomised to one of four groups defined by two "advice" factors: undertake exercises and stop quinine. After 6 weeks they were advised that they could take quinine and undertake the exercises freely. Documentation of cramp at 12 weeks was achieved in 181 (95%) patients. Main outcome measures were: symptom burden score, and frequency of night cramps and quinine usage.

Results

At 12 weeks there was no significant difference in number of cramps in the previous 4 weeks (exercise = 1.95, 95% confidence interval [CI] = -3.01 to 6.90; quinine cessation = 3.45, 95% CI = -1.52 to 8.41) nor symptom burden or severity of cramps. However, after 12 weeks 26.5% (95% CI = 13.3% to 39.7%) more patients who had been advised to stop quinine treatment reported taking no quinine tablets in the previous week (odds ratio [OR] = 3.32, 95% CI = 1.37 to 8.06), whereas advice to do stretching exercises had no effect (OR = 0.73, 95% CI = 0.27 to 1.98).

Conclusions

Calf-stretching exercises are not effective in reducing the frequency or severity of night cramps. Advising those on long-term repeat prescriptions to try stopping quinine temporarily will result in no major problems for patients, and allow a significant number to stop medication.

SUBMITTER: Coppin RJ

PROVIDER: S-EPMC1463088 | biostudies-literature | 2005 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Managing nocturnal leg cramps--calf-stretching exercises and cessation of quinine treatment: a factorial randomised controlled trial.

Coppin Richard J RJ Wicke Dorothy M DM Little Paul S PS

The British journal of general practice : the journal of the Royal College of General Practitioners 20050301 512

<h4>Background</h4>Quinine is a common treatment for nocturnal leg cramps but has potential side effects. An uncontrolled study suggested that calf-stretching exercises could prevent nocturnal leg cramps (night cramps) but these findings have never been confirmed.<h4>Aim</h4>To assess the effect of calf-stretching exercises and cessation of quinine treatment for patients with night cramps taking quinine.<h4>Design of study</h4>Randomised controlled trial.<h4>Setting</h4>Twenty-eight general prac ...[more]

PMID: 15808033

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Project description:ImportanceCurrently, there are no treatments for nocturnal leg cramps (NLCs) that have been proven to be both safe and effective. Seeking safe and effective approaches for managing NLCs is of crucial importance.ObjectiveTo determine whether vitamin K2 is better than placebo in managing NLCs.Design, setting, and participantsThis multicenter, double-blind, placebo-controlled randomized clinical trial was conducted in China between September 2022 and December 2023. This study used a volunteer sample comprising community-dwelling individuals 65 years and older with 2 or more documented episodes of NLCs during 2 weeks of screening. Researchers performed a history and physical screening of candidates recruited from the community through advertisements, and eligible participants were randomized in a 1:1 ratio to receive vitamin K2 or a placebo for 8 weeks.InterventionsPatients orally took capsules containing either vitamin K2 (menaquinone 7), 180 μg, or a similar-looking placebo every day for 8 weeks. The study products were custom manufactured to have identical packaging and for the capsules to have matching appearance and identical excipients that shared similar taste and weight.Main outcomes and measuresThe primary outcome was the mean number of NLCs per week between the vitamin K2 and the placebo group. Secondary outcomes included the duration of muscle cramps measured in minutes and the severity of muscle cramps assessed using an analog scale ranging from 1 to 10.ResultsAmong the 310 participants, 111 participants were excluded. Of the 199 enrolled individuals, 108 (54.3%) were female, and the mean (SD) age was 72.3 (5.5) years. A total of 103 patients (51.8%) were randomly assigned to receive vitamin K2 and 96 (48.2%) were assigned to placebo. The mean (SD) baseline weekly frequency of cramps was comparable in both the vitamin K2 group (2.60 [0.81]) and the placebo group (2.71 [0.80]). During the 8-week intervention, the vitamin K2 group experienced a reduction in the mean (SD) weekly frequency of cramps to 0.96 (1.41). Meanwhile, the placebo group maintained mean (SD) weekly frequency of cramps at 3.63 (2.20). The between-group difference was statistically significant (difference, -2.67; 95% CI, -2.86 to -2.49; P < .001). The vitamin K2 group had a more significant mean (SD) reduction in NLC severity (-2.55 [2.12] points) compared with the placebo group (-1.24 [1.16] points). The vitamin K2 group exhibited a more pronounced mean (SD) decrease in the duration of NLCs (-0.90 [0.88] minutes) than the placebo group (-0.32 [0.78] minutes). No adverse events related to vitamin K2 use were identified.Conclusions and relevanceThis randomized clinical trial showed that vitamin K2 supplementation significantly reduced the frequency, intensity, and duration of NLCs in an older population with good safety.Trial registrationClinicalTrials.gov Identifier: NCT05547750.

Project description:ImportanceMagnesium supplements are widely marketed for prophylaxis of nocturnal leg cramps (NLC) despite no evidence of significant benefit.ObjectiveTo determine whether magnesium oxide is better than placebo for NLC prophylaxis.Design, setting, and participantsA randomized, double-blind, placebo-controlled clinical trial of 2 weeks eligibility screening followed by 4 weeks of treatment was conducted in northern Israel, from February to October 2013. An intention-to-treat data analysis was performed from March 22, 2014, to April 17, 2016. We used a volunteer sample of community-dwelling individuals experiencing NLC, 21 years or older, with 4 or more documented episodes of NLC during 2 weeks of screening.InterventionsCapsules containing either magnesium oxide or a similar-looking placebo to be taken orally, once daily at bedtime for a period of 4 weeks.Main outcomes and measuresThe primary outcome was the difference in the mean number of NLC per week between the screening and treatment phases. Secondary outcomes included severity and duration of NLC, quality of life, and quality of sleep.ResultsOf the 166 volunteers, 72 (43%) were excluded, of whom 15 declined to participate and 57 did not meet the inclusion criteria. Of the 94 individuals (39% male; mean [SD] age, 64.9 [11.1] years) randomly assigned to magnesium oxide (48) or placebo (46), 6 did not complete the study protocol (3 in each group). Mean (SD) change of NLC was -3.41 (4.05) (from 7.84 [5.68] to 4.44 [5.66]) and -3.03 (4.53) (from 8.51 [5.20] to 5.48 [4.93]) per week in the magnesium oxide and placebo groups, respectively, a difference between groups of 0.38 (0.48) NLC per week (P = .67 in an intention-to-treat analysis). There were no between-group differences in the severity and duration of NLC, quality of life, or quality of sleep.Conclusions and relevanceOral magnesium oxide was not superior to placebo for older adults experiencing NLC. The decrease in the mean number of NLC per week, from the screening to the treatment phase in both groups, is probably a placebo effect that may explain the wide use of magnesium for NLC.Trial registrationclinicaltrials.gov Identifier: NCT01709968.

Project description:BackgroundNocturnal leg cramps (NLC) are common and poorly understood.ObjectiveTo determine the prevalence of NLC and associations with cardiometabolic, sleep, and behavioral risk factors in the US population.DesignCross-sectional epidemiology.ParticipantsNational Health and Nutrition Examination Survey, 2005-2006 and 2007-2008 waves.Main outcome(s) and measure(s)NLC were assessed with, "In the past month, how often did you have leg cramps while trying to sleep?" Responses were categorized as None, Mild, or Moderate-Severe. Demographics, medical history, sleep disturbances, and cardiometabolic risk factors were evaluated using the 2005-2006 dataset. Variables that demonstrated significant relationships to NLC after adjusting for age, sex, education, and BMI were assessed in the 2007-2008 dataset. Variables that were still significant were entered into a forward stepwise regression model combining both waves, to determine which variables best explained the variance in NLC.ResultsPrevalence was 24-25% reporting mild and 6% reporting moderate-severe NLC. NLC increased with age, lower education, unemployment, shorter sleep duration, all assessed sleep symptoms (nocturnal "leg jerks", snoring, snorting/gasping, difficulty falling asleep, difficulty maintaining sleep, non-restorative sleep, sleepiness, use of sleep medications), higher BMI, smoking, medical history (hypertension, heart failure, angina, stroke, arthritis, respiratory disease, and cancer), depression symptoms, and biomarkers (CRP, HbA1c, calcium, cadmium, red blood cells). Stepwise analysis showed that moderate-severe nocturnal leg cramps were associated with (in decreasing order of partial R2): leg jerks, poor overall health, arthritis, difficulty falling asleep, age, nonrestorative sleep, red blood cell count, lower education, angina, and difficulty maintaining sleep.Conclusions and relevanceBased on this first large, representative study, NLC occurring >5x per month are reported by 6% of the adult US population. Sleep disturbance symptoms and health conditions are associated with higher frequency of NLC, suggesting that NLC is a marker, and possibly contributor, to poor sleep and general health.

Project description:IntroductionNocturnal leg cramps (NLCs) are sudden contractions of the leg muscles, usually in the posterior calf muscles at night, affecting sleep quality. Because the precise pathophysiology of NCLs is unclear, different interventions have been proposed. There is conflicting evidence regarding the efficacy of conventional interventions in preventing cramps. Thus, the present study aims to investigate the effects of vitamin K2 for NLCs in a prospective randomized, double-blind, controlled trial.Methods and analysisThis 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. Participants will be randomized to receive vitamin K2 or a similar-looking placebo for 8 weeks in a 1:1 ratio. Follow-up visits will be scheduled each week at the beginning of 4-week intervention, then participants will be visited semimonthly. The primary outcome is the difference in the mean number of NLCs per week in the vitamin K2 and placebo arms. The secondary outcomes include the severity and duration of NLCs in the vitamin K2 and placebo arms. 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.DiscussionNocturnal Leg Cramps (NLCs) are a common musculoskeletal disorder in the general population, but effective and safe interventions have not been established. 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. 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. The findings of this RCT will encourage the studies of vitamin K2 in musculoskeletal disorders.Clinical trial registrationwww.ClinicalTrials.gov, identifier, NCT05547750.

Dataset Information

Managing nocturnal leg cramps--calf-stretching exercises and cessation of quinine treatment: a factorial randomised controlled trial.

Background

Aim

Design of study

Setting

Method

Results

Conclusions

Publications

Managing nocturnal leg cramps--calf-stretching exercises and cessation of quinine treatment: a factorial randomised controlled trial.

Similar Datasets

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