Have you or your loved ones been diagnosed with nocturnal leg cramps?

You may be eligible to participate in a nocturnal leg cramps clinical trial.

Have you or your loved ones been diagnosed with nocturnal leg cramps? You may be eligible to participate in a nocturnal leg cramps clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Nocturnal Leg Cramps Clinical Trial in Geneva

NCT02548507 | Observational patient registry

Have you or your loved ones been diagnosed with nocturnal leg cramps?

You may be eligible to participate in a nocturnal leg cramps clinical trial.

Have you or your loved ones been diagnosed with nocturnal leg cramps? You may be eligible to participate in a nocturnal leg cramps clinical trial.

Completed

Male & Female

50 Years +

This study has recruited 129 Participants

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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Details for the study

Population

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

Brief Title

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

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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

Study 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.