Cross-Sectional Study: Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00557258
Recruitment Status : Completed
First Posted : November 12, 2007
Last Update Posted : February 13, 2009
Information provided by:
Boehringer Ingelheim

Brief Summary:

The proposed study is a Cross-sectional epidemiological study, performed in 330 primary care practices in Germany. The study will be conducted on a fixed day in November 2007.

Primary care surgeries throughout Germany will be asked to take part. The study material will be delivered to the surgery by a member of sales-force who will also explain the study conduct to the physician/staff. Physicians who want to take part in the study will send a signed contract to BI. Physicians will be trained to diagnose RLS.

All patients attending the participating surgeries on a fixed day will be invited to participate in the study. The patients will be handed a questionnaire to fill out while waiting for their appointment. No patient-related data apart from gender and year of birth will be recorded on the questionnaire and it will be ensured that no re-identification of patients is possible. Therefore, no written informed consent will be obtained from the participants.

The patient questionnaire will consist of the following items:

A screening questionnaire for RLS (according to Stiasny-Kolster et. al., data on file) Additional questions concerning the impact of the patients leg problems on daily life.

The practice staff will then collect the questionnaire. All patients who have answered question 1 (asking for unpleasant sensations of the legs) with ¿Yes¿ will subsequently be assessed for the diagnosis by the physician.

The physician fills out a second questionnaire, covering the following items:

Diagnosis (cause of leg problems) Concomitant diagnoses and therapies If the diagnosis of RLS was made: consequences (therapy)? Was the diagnosis of RLS pre-known? All completed questionnaires will be sent to data management by the surgery within 2 working days.

Condition or disease
Restless Legs Syndrome

Study Type : Observational
Actual Enrollment : 14956 participants
Official Title: Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs
Study Start Date : November 2007
Actual Primary Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients attending one of the participating primary care surgeries on a fixed day
  • Male or female patients of any age

Exclusion Criteria:

  • Patients who only attend the practice to get a prescription and are not seen by the doctor on that day.
  • Patients who are not able to understand the questionnaire due to mental impairment or language problems.
  • Children and adolescents under the age of 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00557258

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Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim Identifier: NCT00557258     History of Changes
Other Study ID Numbers: 248.652
First Posted: November 12, 2007    Key Record Dates
Last Update Posted: February 13, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders