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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Alberto Doretti, MD
- Telefoonnummer: 2937 +39-0261911
- E-mail: a.doretti@auxologico.it
Studie Contact Back-up
- Naam: Luca G Grappiolo
- Telefoonnummer: 2894 +39-0261911
- E-mail: luca.grappiolo@auxologico.it
Studie Locaties
-
-
-
Milan, Italië, 20149
- Werving
- Istituto Auxologico Italiano
-
Contact:
- Alberto Doretti, MD
- Telefoonnummer: 2937 +39-0261911
- E-mail: a.doretti@auxologico.it
-
Contact:
- E-mail: neurotrial@auxologico.it
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Doraldo Castelletti scale
Migraine patients are the targeted population for administration of the Doraldo-Castelletti scale during a neurological visit
|
During a routine neurological examination, the physician administers the Doraldo-Castelletti scale to the migraine patient.
The scale consists of 10 multiple choice questions.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Score of the Doraldo-Castelletti scale
Tijdsspanne: At baseline
|
Scale consisting of 10 multiple choice questions; Minimum score = 0; Maximum score = 13
|
At baseline
|
|
Proportion of patients referred to physiotherapist
Tijdsspanne: At baseline
|
Proportion of patients referred to physiotherapist on the basis of the score of the Doraldo-Castelletti scale
|
At baseline
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 23C513
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .