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.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Lise Laclautre
- 电话号码:+33473754963
- 邮箱:promo_interne_drci@chu-clermontferrand.fr
学习地点
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Clermont-Ferrand、法国
- CHU de Clermont-Ferrand
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首席研究员:
- Livia FANTINI
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接触:
- Lise Laclautre
- 电话号码:33473754963
- 邮箱:promo_interne_drci@chu-clermontferrand.fr
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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. |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Pain evaluation according to the Brief Pain Inventory (PBI)
大体时间:at day 0
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at day 0
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Pain characteristics using the DN4 questionnaire
大体时间: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)
大体时间:at day 0
|
at day 0
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Fibromyalgia using the FIRST (Fibromyalgia Rapid Screening Tool)
大体时间:at day 0
|
at day 0
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Biopsychosocial dimensions of pain according to the Pain Catastrophizing Scale (PCS).
大体时间: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)
大体时间:at day 0
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at day 0
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Quality of life using the EQ-5D-5L
大体时间:at day 0
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at day 0
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Daytime sleepiness using Epworth Sleepiness Scale (ESS).
大体时间: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).
大体时间:at day 0
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at day 0
|
合作者和调查者
调查人员
- 首席研究员:Livia FANTINI、University Hospital, Clermont-Ferrand
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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