Clinical trial NCT00557258: Cross-Sectional Study: Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs
Official title: Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Restless Legs Syndrome
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2007-11-12
Enrollment: 14956
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Aalen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Ahlen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Altena
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Altensteig
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Altomünster
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Alveslohe
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Annaberg-Buchholz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Apolda
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Artern
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Aschersleben
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Aub
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Babenhausen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Bevensen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Buchau
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Essen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Krozingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Laasphe
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Langensalza
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Schussenried
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bautzen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bergholz-Rehbrücke
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bernburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bernsdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bevern
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Biberach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bienenbüttel
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Birkenwerder
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bisingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bodelshausen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bodenwöhr
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bornheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Braunschweig
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bremen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Buckenhof
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Burgdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Burgheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Burgoberbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bückeburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Büdelsdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bünde
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Calbe
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Calw
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Castrop-Rauxel
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Celle
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Chemnitz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Coppenbrügge
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Cottbus
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Cuxhaven
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Daun
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Delligsen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Denkendorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Dillingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Donauwörth
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Dormagen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Dorn-Dürkheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Dortmund
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Dreieich
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Duisburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Dänischenhagen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Dörentrup
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Düren
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Edenkoben
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Eisingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Elsenfeld
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Emsdetten
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Eppelheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Erftstadt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Erfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Erlangen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Erndtebrück
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Eschau
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Essen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Esslingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Eutin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Extertal
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Falkensee
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Freiburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Freising
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Friedenfels
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Friedrichsthal
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Fulda
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Fürstenwalde
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Geiselhöring
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gelsenkirchen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gensingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Germering
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gladbeck
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Glashütten
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Greiz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Großenkneten
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Großenlüder
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Grömitz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Göttingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Haag
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hagen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Halle
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Haltern
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hamminkeln
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hanerau-Hademarschen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Harsewinkel
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hartenstein
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hattorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Heilbronn
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Heinsberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Herbertshofen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Herbrechtingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hermsdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hohenhameln
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hosena
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hude
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Ippesheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Ispringen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Jahnsdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Jever
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Jühnde
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Jünkerath
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kahl
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kalbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kamen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kassel
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Katzhütte
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kaufbeuren
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kirchardt
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kirchheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kirchlengern
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kitzingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kressbronn
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kronach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kropp
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Krumbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kuppenheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Laatzen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Lahnau
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Lahr
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Lampertheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Langenfeld
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Langen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Lauf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Leer
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Lehrberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Lengefeld
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Leonberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Leverkusen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Lienen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Lohfelden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Lohra
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Ludwigshafen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Lunzenau
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Lüderitz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Lütjenburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Magdeburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mannheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Marburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Meerbusch
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Meldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mendig
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mengkofen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Meßstetten
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mindelheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mittweida
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Moosburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mosbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mönchengladbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mühlhausen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mülheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Niederndodeleben
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Nienburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Oberdorla
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Oberursel
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Oer-Erkenschwick
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Olbernhau
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Olfen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Osnabrück
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Ostrach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Parey
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Petershagen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Pirmasens
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Plattling
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Pleidelsheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Potsdam
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Pulheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rastede
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Remscheid
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rhaunen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Roggendorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rossau
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rostock
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Röthenbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Saerbeck
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Schorndorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Schwarzenbach a Wald
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Schwerte
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Schwäbisch Gmünd
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Schönau
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Schönebeck
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Seelow
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Selfkant
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Senftenberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Siegen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Solingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Sonsbeck
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Speyer
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Sprendlingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Stadland
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Stadthagen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Straubing
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Stuhr
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Stutensee
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Suhl
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Sulzbach-Rosenberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Sulzbach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Sögel
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Teterow
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Tettnang
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Thaleischweiler-Fröschen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Troisdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Veilsdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Vellahn
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Viernheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Villingen-Schwenningen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Waghäusel
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wehrsdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Weibern
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Weimar
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Welzheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wemding
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wertingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wesel
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wesseling
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wetzendorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wetzlar
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wickede
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wiesbaden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Winsen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wöbbelin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Zschocken
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Zschopau
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Zweibrücken
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Zwickau
country: Germany
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: