Nocturnal Leg Cramps in Geneva : an Observational Study

NCT02548507 | Completed

• 1 other identifier: CNMI
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Wake Transition Disorders; Nocturnal Leg Cramps

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Frequency of NLC

  During two weeks after recruitment

• Duration of nocturnal leg cramps

  During two weeks after recruitment

• Severity of pain related with nocturnal leg cramps

  During two weeks after recruitment

• Severity of sleep disturbance related with nocturnal leg cramps

  During two weeks after recruitment

• Patient expectancies for nocturnal leg cramps treatment

  Two weeks after recruitment

Interventions

observational study, no intervention OTHER

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Geneva, Switzerland: lead

Study Sites (1)

Primary care network

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Sleep-Wake Transition Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Hubert Maisonneuve, MD

  University of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maitre d'enseignement et de recherche

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 14, 2015
• Study Start: March 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: April 1, 2018
• Last Updated: May 22, 2018

Record last verified: 2018-05

Locations

CH (1)