Study of the Frequency and Characteristics of Pain Symptoms in Restless Legs Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients with RLS.
- Who it may be relevant to
- Registry conditions: RLS. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Patients with RLS
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 b
Primary outcome measures
- Pain evaluation according to the Brief Pain Inventory (PBI) [Time frame: at day 0]
Secondary outcome measures (8)
- Pain characteristics using the DN4 questionnaire [Time frame: at day 0]
- RLS severity using the International Restless Legs Syndrome Rating Scale (IRLS) [Time frame: at day 0]
- Fibromyalgia using the FIRST (Fibromyalgia Rapid Screening Tool) [Time frame: at day 0]
- Biopsychosocial dimensions of pain according to the Pain Catastrophizing Scale (PCS). [Time frame: at day 0]
- Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS) [Time frame: at day 0]
- Quality of life using the EQ-5D-5L [Time frame: at day 0]
- Daytime sleepiness using Epworth Sleepiness Scale (ESS). [Time frame: at day 0]
- RLS-specific quality of life using the Restless Legs Syndrome Quality of Life questionnaire (RLS-QOL). [Time frame: at day 0]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 1 center
- CHU de Clermont-Ferrand — Clermont-Ferrand
Identifiers
NCT: NCT07679087 · RNI 2026 FANTINI (PAIN-RLS) · 2026-A00401-50