- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Lise LACLAUTRE
- Numero di telefono: +33473754963
- Email: promo_interne_drci@chu-clermontferrand.fr
Luoghi di studio
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Clermont-Ferrand, Francia
- CHU de Clermont-Ferrand
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Investigatore principale:
- Livia FANTINI
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Contatto:
- Lise Laclautre
- Numero di telefono: 33473754963
- Email: promo_interne_drci@chu-clermontferrand.fr
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Pain evaluation according to the Brief Pain Inventory (PBI)
Lasso di tempo: at day 0
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at day 0
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Pain characteristics using the DN4 questionnaire
Lasso di tempo: 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)
Lasso di tempo: at day 0
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at day 0
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Fibromyalgia using the FIRST (Fibromyalgia Rapid Screening Tool)
Lasso di tempo: 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).
Lasso di tempo: 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)
Lasso di tempo: at day 0
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at day 0
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Quality of life using the EQ-5D-5L
Lasso di tempo: at day 0
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at day 0
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Daytime sleepiness using Epworth Sleepiness Scale (ESS).
Lasso di tempo: 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).
Lasso di tempo: at day 0
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at day 0
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Livia FANTINI, University Hospital, Clermont-Ferrand
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RNI 2026 FANTINI (PAIN-RLS)
- 2026-A00401-50 (Altro identificatore: IDRCB)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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