Prevalence, Main Features and Treatment of Nocturnal Leg Cramps in Geneva: A Primary Care Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Prevalence of NLC
研究概览
简要总结
Background :
Nocturnal leg cramps (NLC) are defined as painful involuntary contractions of the lower limbs occurring during prolonged periods of rest, typically during the night. They may cause severe pain and sleep disturbance, and are particularly common among older adults, though they can occur in all decades of life. They are frequently unreported to physicians. To the investigators' knowledge, no epidemiological studies have been conducted in Switzerland, but in a general population survey carried out in the UK (n=233), the overall prevalence of NLC was 37% and the disorder was more prevalent in older subjects (>80 years old: 54%). Of those who experienced NLC, 40% had cramps three or more times per week and 6% nightly. Another study performed in older US veterans (n=515) showed that 56% suffered from NLC.
The precise cause of these cramps is unclear. Most NLC occurring in adults appear to be idiopathic, but potential contributing factors include low levels of certain minerals, extracellular fluid volume depletion and prolonged sitting or inappropriate leg position during sedentary activity.
Research question :
What are the prevalence and the main features of NLC in patients consulting primary care physicians (PCPs) in Geneva, and how do PCPs treat this affection?
Primary objective :
To compute the prevalence of NLC in patients consulting PCPs in Geneva, explore its main features (number, duration, severity and sleep disturbance) and assess how PCPs treat this affection.
Study design :
Prospective observational study using questionnaire and daily log completed by patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of 50 years old or more,
- •currently presenting NLC (The definition of NLC used for the purpose of the study is any cramp in the legs or feet, occurring during the sleep (eg long rest) period).
- •coming to the practice for a planned consultation.
排除标准
- •Patients suffering from a terminal illness
- •from disorders affecting their ability to consent,
- •not speaking French
- •or not having a telephone.
结局指标
主要结局
Prevalence of NLC
时间窗: Presence or absence of NLC will be checked during the time of recruitment for each participant PCP, with expected average of 1 to 6 months.
In order to compute the prevalence of NLC, the PCPs will be asked to specify for each patient coming for a planned consultation whether he/she has NLC, meets the inclusion criteria and accept to participate (group 1), has NLC, meets the inclusion criteria but refuses to participate (group 2) or has NLC but does not meet the inclusion criteria (group 3). For patients in the group 1 doctors will record the current date, the name and the first name, the gender, the date of birth and the phone number; for patients in the group 2 they will record the current date, the gender and the date of birth; and finally for patients in the group 3 they will record the current date, the gender, the date of birth and the exclusion criterion.
次要结局
- Patient quality of sleep(1 year after initial recruitment)
- Frequency of NLC(During two weeks after recruitment)
- Severity of sleep disturbance related with nocturnal leg cramps(During two weeks after recruitment)
- Duration of nocturnal leg cramps(During two weeks after recruitment)
- Patient quality of life(1 year after initial recruitment)
- Patient expectancies for nocturnal leg cramps treatment(Two weeks after recruitment)
- Severity of pain related with nocturnal leg cramps(During two weeks after recruitment)
研究者
Maisonneuve Hubert
Maitre d'enseignement et de recherche
University of Geneva, Switzerland