Nocturnal Leg Cramps in Geneva : an Observational Study

Nocturnal Leg Cramps Clinical Trial

— CNMI  

Official title:

Prevalence, Main Features and Treatment of Nocturnal Leg Cramps in Geneva: A Primary Care Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02548507
• Other study ID #: CNMI
• Status: Completed
• Start date: March 2015
• Est. completion date: April 2018

Study information

• Verified date: May 2018
• Source: University of Geneva, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: April 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Cramp
• Nocturnal Leg Cramps
• Sleep Wake Transition Disorders

Intervention

Other:
• observational study, no intervention

Locations

Country	Name	City	State
Switzerland	Primary care network	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of NLC	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.	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	Frequency of NLC	Voluntaries will record during two weeks the number of cramps in a daily log.	During two weeks after recruitment
Secondary	Duration of nocturnal leg cramps	Voluntaries will record during two weeks the duration of cramps in a daily log.	During two weeks after recruitment
Secondary	Severity of pain related with nocturnal leg cramps	Voluntaries will record the severity of cramps in a daily log, standardized on an analog numerical scale of 1 to 10 .	During two weeks after recruitment
Secondary	Severity of sleep disturbance related with nocturnal leg cramps	Voluntaries will record the severity of sleep disturbance related with NLC, in a daily log, standardized on an analog numerical scale of 1 to 10.	During two weeks after recruitment
Secondary	Patient expectancies for nocturnal leg cramps treatment	We will ask the voluntaries to specify the average pain and sleep disturbance related with NLC on analog numerical scale of 1 to 10. We'll then ask them what improvement they would expect from a treatment on the same analog numeric scale for pain and sleep disturbance.	Two weeks after recruitment
Secondary	Patient quality of life	Voluntaries will fill a SF36 questionnaire	1 year after initial recruitment
Secondary	Patient quality of sleep	Voluntaries will fill a PSQI questionnaire	1 year after initial recruitment