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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Lise Laclautre
- 電話番号:+33473754963
- メール:promo_interne_drci@chu-clermontferrand.fr
研究場所
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-
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Clermont-Ferrand、フランス
- CHU de Clermont-Ferrand
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主任研究者:
- Livia FANTINI
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コンタクト:
- Lise Laclautre
- 電話番号:33473754963
- メール:promo_interne_drci@chu-clermontferrand.fr
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Pain evaluation according to the Brief Pain Inventory (PBI)
時間枠:at day 0
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at day 0
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Pain characteristics using the DN4 questionnaire
時間枠: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)
時間枠:at day 0
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at day 0
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Fibromyalgia using the FIRST (Fibromyalgia Rapid Screening Tool)
時間枠: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).
時間枠: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)
時間枠:at day 0
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at day 0
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Quality of life using the EQ-5D-5L
時間枠:at day 0
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at day 0
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Daytime sleepiness using Epworth Sleepiness Scale (ESS).
時間枠: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).
時間枠:at day 0
|
at day 0
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協力者と研究者
捜査官
- 主任研究者:Livia FANTINI、University Hospital, Clermont-Ferrand
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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