Nocturnal Leg Cramps in Geneva : an Observational Study (CNMI)

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

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.

Study Overview

• Status: Completed
• Conditions: Nocturnal Leg Cramps; Sleep Wake Transition Disorders
• Intervention / Treatment: Other: observational study, no intervention

• Study Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Primary care network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients of 50 years old or more, consulting primary care physicians in Geneva

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of NLC	Voluntaries will record during two weeks the number of cramps in a daily log.	During two weeks after recruitment
Duration of nocturnal leg cramps	Voluntaries will record during two weeks the duration of cramps in a daily log.	During two weeks after recruitment
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
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
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
Patient quality of life	Voluntaries will fill a SF36 questionnaire	1 year after initial recruitment
Patient quality of sleep	Voluntaries will fill a PSQI questionnaire	1 year after initial recruitment

Collaborators and Investigators

• Sponsor: University of Geneva, Switzerland
• Investigators: Principal Investigator: Hubert Maisonneuve, MD, University of Genova

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: September 9, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimate): September 14, 2015

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Parasomnias; Muscle Cramp; Sleep-Wake Transition Disorders
• Other Study ID Numbers: CNMI