Clinical trial NCT02548507: Nocturnal Leg Cramps in Geneva : an Observational Study
Official title: Prevalence, Main Features and Treatment of Nocturnal Leg Cramps in Geneva: A Primary Care Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Wake Transition Disorders
Nocturnal Leg Cramps
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 129
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of 50 years old or more, consulting primary care physicians in Geneva

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients suffering from a terminal illness
* from disorders affecting their ability to consent,
* not speaking French
* or not having a telephone.

Primary outcomes:
measure: Prevalence of NLC
timeFrame: 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.
Secondary outcomes:
measure: Frequency of NLC
timeFrame: During two weeks after recruitment
measure: Duration of nocturnal leg cramps
timeFrame: During two weeks after recruitment
measure: Severity of pain related with nocturnal leg cramps
timeFrame: During two weeks after recruitment
measure: Severity of sleep disturbance related with nocturnal leg cramps
timeFrame: During two weeks after recruitment
measure: Patient expectancies for nocturnal leg cramps treatment
timeFrame: Two weeks after recruitment
measure: Patient quality of life
timeFrame: 1 year after initial recruitment
measure: Patient quality of sleep
timeFrame: 1 year after initial recruitment
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Primary care network
Study officials:
affiliation: University of Geneva
name: Hubert Maisonneuve, MD
role: PRINCIPAL_INVESTIGATOR
References: