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Completed

NCT Number: NCT02548507

Nocturnal Leg Cramps in Geneva : an 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.

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Key information

Conditions

Sleep Wake Transition Disorders Mental Disorders Nervous System Diseases Nocturnal Leg Cramps Parasomnias Sleep Wake Disorders Sleep-Wake Transition Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Primary care network

Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational study, no intervention

Other

Primary outcomes

  1. Prevalence of NLC

    Time frame: 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.

Secondary outcomes

  1. Frequency of NLC

    Time frame: During two weeks after recruitment

    Voluntaries will record during two weeks the number of cramps in a daily log.

  2. Duration of nocturnal leg cramps

    Time frame: During two weeks after recruitment

    Voluntaries will record during two weeks the duration of cramps in a daily log.

  3. Severity of pain related with nocturnal leg cramps

    Time frame: During two weeks after recruitment

    Voluntaries will record the severity of cramps in a daily log, standardized on an analog numerical scale of 1 to 10 .

  4. Severity of sleep disturbance related with nocturnal leg cramps

    Time frame: During two weeks after recruitment

    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.

  5. Patient expectancies for nocturnal leg cramps treatment

    Time frame: Two weeks after recruitment

    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.

  6. Patient quality of life

    Time frame: 1 year after initial recruitment

    Voluntaries will fill a SF36 questionnaire

  7. Patient quality of sleep

    Time frame: 1 year after initial recruitment

    Voluntaries will fill a PSQI questionnaire

Sponsors and collaborators

Lead sponsor

University of Geneva, Switzerland

Other

Registry information

Official study title

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

Acronym: CNMI

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Sep 14, 2015
Registry last updated
May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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