- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07679087
Study of the Frequency and Characteristics of Pain Symptoms in Restless Legs Syndrome (PAIN-RLS)
Restless Legs Syndrome (RLS) is a neurological disorder affecting between 4% and 29% of adults. It is characterized by an urge to move the legs or other parts of the body, often accompanied by unpleasant and sometimes painful sensations. The pathophysiology of RLS, whether associated with pain or not, remains poorly understood, and only a limited number of studies have specifically investigated this aspect.
The aim of this study is to determine the prevalence of the painful component of symptoms in a large cohort of patients with RLS, to further characterize its clinical features, and to assess its impact on patients' quality of life. This work could improve the identification of patients experiencing pain, enhance our understanding of pain characteristics in RLS, and help optimize patient management. Furthermore, in the context of emerging therapeutic approaches such as neuromodulation, a better characterization of pain in RLS may contribute to the development and evaluation of new treatment strategies. This is particularly relevant given the high prevalence of RLS and its substantial impact on patients' quality of life.
Participants will be recruited either through their neurologist during routine follow-up visits at the Neurology Department of Clermont-Ferrand University Hospital or through the France Ekbom Association. Individuals interested in participating will be provided with access to the online questionnaire via a QR code or a dedicated web link. One thousand patients will be include in this study (RIPH type 3). The online questionnaire is expected to take approximately 30 minutes to complete. It includes the collection of demographic data (age, sex, lifestyle factors, weight, height, employment status, comorbidities, and dietary habits), as well as questions regarding the patient's medical history and sleep habits.
The questionnaire also includes validated instruments assessing sleep, pain, RLS severity, anxiety and depression, and quality of life.
At the end of the questionnaire, participants will be invited to take part in an optional ancillary study aimed at validating the French translation of the Restless Legs Syndrome Quality of Life questionnaire (RLS-QOL). Participants who agree to participate will complete the questionnaire once at baseline and will subsequently receive an email reminder to complete it a second time two weeks later. This test-retest procedure will be used to assess the reproducibility of the French-adapted version of the questionnaire.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Lise Laclautre
- Numéro de téléphone: +33473754963
- E-mail: promo_interne_drci@chu-clermontferrand.fr
Lieux d'étude
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Clermont-Ferrand, France
- CHU de Clermont-Ferrand
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Chercheur principal:
- Livia FANTINI
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Contact:
- Lise Laclautre
- Numéro de téléphone: 33473754963
- E-mail: promo_interne_drci@chu-clermontferrand.fr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Male or female participants aged 18 years or older.
- Diagnosis of Restless Legs Syndrome (RLS) according to the criteria of the International Classification of Sleep Disorders, Third Edition (ICSD-3).
- French-speaking.
Exclusion Criteria:
- Patient under guardianship, curatorship, or legal protection measures.
- Patient who has never had an appointment with a neurologist as part of their SJSR care pathway.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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RLS patient
Patients with a diagnosis of Restless Legs Syndrome (RLS) confirmed by a sleep specialist
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The online questionnaire is expected to take approximately 30 minutes to complete. It includes the collection of demographic data (age, sex, lifestyle factors, weight, height, employment status, comorbidities, and dietary habits), as well as questions regarding the patient's medical history and sleep habits. The questionnaire also includes validated instruments assessing sleep, pain, RLS severity, anxiety and depression, and quality of life. At the end of the questionnaire, participants will be invited to take part in an optional ancillary study aimed at validating the French translation of the Restless Legs Syndrome Quality of Life questionnaire (RLS-QOL). Participants who agree to participate will complete the questionnaire once at baseline and will subsequently receive an email reminder to complete it a second time two weeks later. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Pain evaluation according to the Brief Pain Inventory (PBI)
Délai: at day 0
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at day 0
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Pain characteristics using the DN4 questionnaire
Délai: at day 0
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at day 0
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RLS severity using the International Restless Legs Syndrome Rating Scale (IRLS)
Délai: at day 0
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at day 0
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Fibromyalgia using the FIRST (Fibromyalgia Rapid Screening Tool)
Délai: at day 0
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at day 0
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Biopsychosocial dimensions of pain according to the Pain Catastrophizing Scale (PCS).
Délai: at day 0
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at day 0
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Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS)
Délai: at day 0
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at day 0
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Quality of life using the EQ-5D-5L
Délai: at day 0
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at day 0
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Daytime sleepiness using Epworth Sleepiness Scale (ESS).
Délai: at day 0
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at day 0
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RLS-specific quality of life using the Restless Legs Syndrome Quality of Life questionnaire (RLS-QOL).
Délai: at day 0
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at day 0
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Livia FANTINI, University Hospital, Clermont-Ferrand
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RNI 2026 FANTINI (PAIN-RLS)
- 2026-A00401-50 (Autre identifiant: IDRCB)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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