Evaluation of the Performance of the Doraldo-Castelletti Scale in Supporting the Neurologist's Decision to Refer Migraine Patients to Physiotherapy (MIGSKA)
Multicenter Interventional Study for the Evaluation of the Performance of the Doraldo-Castelletti Scale in Supporting the Neurologist's Decision to Refer Migraine Patients to Physiotherapy (MIGSKA)
Migraine is the leading cause of disability worldwide among people aged 15 to 49. Although therapies targeting the CGRP pathway have improved the management of the condition, there are large groups of patients who do not respond to medications or for whom these are contraindicated. In this context, non-pharmacological therapies such as physical therapy play a crucial role.
The scientific literature highlights a strong link between migraine and cervical disorders:
- 77% of migraine patients suffer from neck pain.
- 93% have at least three musculoskeletal dysfunctions in the cervical region.
- Patients with cervical symptoms experience more frequent attacks, greater disability, a poorer response to medication, and a higher risk of chronicity.
Despite the proven utility of physical therapy for the prevention and treatment of migraine (as demonstrated by validated physical tests and standardized questionnaires such as the NDI, HDI, and HIT-6), musculoskeletal screening is not routinely included in neurological examinations. Neurologists in headache centers generally lack the time and specific manual skills required to perform a thorough physical assessment of the cervical spine.
There is therefore a lack of a rapid and effective screening tool that serves as a "bridge" between neurology and rehabilitation.
The primary objective of the MIGSKA study is to evaluate the performance of the Doraldo-Castelletti scale in assessing the clinical need and motivation of patients with migraine to undergo physical therapy. The study will also assess the utility of this scale as a decision-making tool for neurologists in referring appropriate patients to physical therapists.
To address this gap in clinical practice, the study analyzes the Doraldo-Castelletti scale. The adoption of this tool aims to:
- Easily identify migraine patients with significant musculoskeletal dysfunction.
- Quantify the patient's attitude and motivation toward manual therapy (a determining factor for treatment success).
- Provide the neurologist with an objective and rapid criterion for prescribing a specialized physical therapy evaluation, promoting a genuine and effective multidisciplinary approach to migraine care.
調査の概要
詳細な説明
Migraine is the leading cause of disability worldwide among people aged 15 to 49. Although therapies targeting the CGRP pathway have improved the management of the condition, there are large groups of patients who do not respond to medications or for whom these are contraindicated. In this context, non-pharmacological therapies such as physical therapy play a crucial role.
The scientific literature highlights a strong link between migraine and cervical disorders:
- 77% of migraine patients suffer from neck pain.
- 93% have at least three musculoskeletal dysfunctions in the cervical region.
- Patients with cervical symptoms experience more frequent attacks, greater disability, a poorer response to medication, and a higher risk of chronicity.
Despite the proven utility of physical therapy for the prevention and treatment of migraine (as demonstrated by validated physical tests and standardized questionnaires such as the NDI, HDI, and HIT-6), musculoskeletal screening is not routinely included in neurological examinations. Neurologists in headache centers generally lack the time and specific manual skills required to perform a thorough physical assessment of the cervical spine.
There is therefore a lack of a rapid and effective screening tool that serves as a "bridge" between neurology and rehabilitation.
The primary objective of the MIGSKA study is to evaluate the performance of the Doraldo-Castelletti scale in assessing the clinical need and motivation of patients with migraine to undergo physical therapy. The study will also assess the utility of this scale as a decision-making tool for neurologists in referring appropriate patients to physical therapists.
To address this gap in clinical practice, the study analyzes the Doraldo-Castelletti scale. The adoption of this tool aims to:
- Easily identify migraine patients with significant musculoskeletal dysfunction.
- Quantify the patient's attitude and motivation toward manual therapy (a determining factor for treatment success).
- Provide the neurologist with an objective and rapid criterion for prescribing a specialized physical therapy evaluation, promoting a genuine and effective multidisciplinary approach to migraine care.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Alberto Doretti, MD
- 電話番号:2937 +39-0261911
- メール:a.doretti@auxologico.it
研究連絡先のバックアップ
- 名前:Luca G Grappiolo
- 電話番号:2894 +39-0261911
- メール:luca.grappiolo@auxologico.it
研究場所
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Milan、イタリア、20149
- 募集
- Istituto Auxologico Italiano
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コンタクト:
- Alberto Doretti, MD
- 電話番号:2937 +39-0261911
- メール:a.doretti@auxologico.it
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コンタクト:
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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
説明
Inclusion Criteria:
- Age between 18 and 70 years (inclusive)
- Diagnosis of migraine established by a neurologist specialized in headache disorders
- Headache Impact Test (HIT-6) ≥ 42
- Ability to understand the study informed consent
- Signed informed consent
- Ability to comply with the study procedures
Exclusion Criteria:
- Neurological diseases confounding the primary objective
- Conditions confounding the primary objective (e.g., fibromyalgia, which could limit patient evaluation by the physiotherapist)
- Previous physiotherapy treatments specifically for headache management
- Psychiatric disorders confounding and/or interfering with the primary objective
- Unstable psychiatric illness, cognitive impairment, dementia, or substance abuse compromising the participant's ability to provide informed consent, according to the investigator's judgment
- Previous neurosurgical interventions involving the cervical region
- Any condition deemed contraindicating study participation according to the investigator's judgment
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
- 主な目的:支持療法
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Doraldo Castelletti scale
Migraine patients are the targeted population for administration of the Doraldo-Castelletti scale during a neurological visit
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During a routine neurological examination, the physician administers the Doraldo-Castelletti scale to the migraine patient.
The scale consists of 10 multiple choice questions.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Score of the Doraldo-Castelletti scale
時間枠:At baseline
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Scale consisting of 10 multiple choice questions; Minimum score = 0; Maximum score = 13
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At baseline
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Proportion of patients referred to physiotherapist
時間枠:At baseline
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Proportion of patients referred to physiotherapist on the basis of the score of the Doraldo-Castelletti scale
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At baseline
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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
本研究に関する用語
その他の研究ID番号
- 23C513
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Doraldo-Castelletti scaleの臨床試験
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NEUROPHETAjou University Hospital, Suwon, South Korea完了
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Assistance Publique - Hôpitaux de Paris完了