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Study of the Frequency and Characteristics of Pain Symptoms in Restless Legs Syndrome (PAIN-RLS)

25 juni 2026 uppdaterad av: University Hospital, Clermont-Ferrand

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Beräknad)

1000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patients will be contacted through the France Ekbom Association or identified during routine consultations. Those who are interested in participating in the study will be able to access the online questionnaire via a QR code or a web link.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
RLS patient
Patients with a diagnosis of Restless Legs Syndrome (RLS) confirmed by a sleep specialist

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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Pain evaluation according to the Brief Pain Inventory (PBI)
Tidsram: at day 0
at day 0

Sekundära resultatmått

Resultatmått
Tidsram
Pain characteristics using the DN4 questionnaire
Tidsram: at day 0
at day 0
RLS severity using the International Restless Legs Syndrome Rating Scale (IRLS)
Tidsram: at day 0
at day 0
Fibromyalgia using the FIRST (Fibromyalgia Rapid Screening Tool)
Tidsram: at day 0
at day 0
Biopsychosocial dimensions of pain according to the Pain Catastrophizing Scale (PCS).
Tidsram: at day 0
at day 0
Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS)
Tidsram: at day 0
at day 0
Quality of life using the EQ-5D-5L
Tidsram: at day 0
at day 0
Daytime sleepiness using Epworth Sleepiness Scale (ESS).
Tidsram: at day 0
at day 0
RLS-specific quality of life using the Restless Legs Syndrome Quality of Life questionnaire (RLS-QOL).
Tidsram: at day 0
at day 0

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Livia FANTINI, University Hospital, Clermont-Ferrand

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juli 2026

Primärt slutförande (Beräknad)

1 augusti 2027

Avslutad studie (Beräknad)

1 augusti 2027

Studieregistreringsdatum

Först inskickad

25 juni 2026

Först inskickad som uppfyllde QC-kriterierna

25 juni 2026

Första postat (Faktisk)

1 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • RNI 2026 FANTINI (PAIN-RLS)
  • 2026-A00401-50 (Annan identifierare: IDRCB)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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