- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lise Laclautre
- Número de teléfono: +33473754963
- Correo electrónico: promo_interne_drci@chu-clermontferrand.fr
Ubicaciones de estudio
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Clermont-Ferrand, Francia
- CHU de Clermont-Ferrand
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Investigador principal:
- Livia FANTINI
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Contacto:
- Lise Laclautre
- Número de teléfono: 33473754963
- Correo electrónico: promo_interne_drci@chu-clermontferrand.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Pain evaluation according to the Brief Pain Inventory (PBI)
Periodo de tiempo: at day 0
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at day 0
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Pain characteristics using the DN4 questionnaire
Periodo de tiempo: 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)
Periodo de tiempo: at day 0
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at day 0
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Fibromyalgia using the FIRST (Fibromyalgia Rapid Screening Tool)
Periodo de tiempo: 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).
Periodo de tiempo: 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)
Periodo de tiempo: at day 0
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at day 0
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Quality of life using the EQ-5D-5L
Periodo de tiempo: at day 0
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at day 0
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Daytime sleepiness using Epworth Sleepiness Scale (ESS).
Periodo de tiempo: 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).
Periodo de tiempo: at day 0
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at day 0
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Livia FANTINI, University Hospital, Clermont-Ferrand
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RNI 2026 FANTINI (PAIN-RLS)
- 2026-A00401-50 (Otro identificador: IDRCB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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