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- Ensaio Clínico NCT07626307
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.
Visão geral do estudo
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Alberto Doretti, MD
- Número de telefone: 2937 +39-0261911
- E-mail: a.doretti@auxologico.it
Estude backup de contato
- Nome: Luca G Grappiolo
- Número de telefone: 2894 +39-0261911
- E-mail: luca.grappiolo@auxologico.it
Locais de estudo
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Milan, Itália, 20149
- Recrutamento
- Istituto Auxologico Italiano
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Contato:
- Alberto Doretti, MD
- Número de telefone: 2937 +39-0261911
- E-mail: a.doretti@auxologico.it
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Contato:
- E-mail: neurotrial@auxologico.it
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Score of the Doraldo-Castelletti scale
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 23C513
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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Ensaios clínicos em Doraldo-Castelletti scale
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Jasper A. SmitsNational Institute on Drug Abuse (NIDA)ConcluídoParar de fumar | Redução do tabagismo | Dependência de nicotina | Desejo | Fumar, cigarro | Comportamentos de fumarEstados Unidos