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Evaluation of the Performance of the Doraldo-Castelletti Scale in Supporting the Neurologist's Decision to Refer Migraine Patients to Physiotherapy

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)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07626307
Acronym
MIGSKA
Enrollment
439
Registered
2026-06-04
Start date
2025-11-20
Completion date
2027-10-01
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Migraine, Physiotherapy, Neurology visit, Doraldo-Castelletti scale, Headache Impact Test, Neck Disability Index

Brief summary

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.

Detailed description

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.

Interventions

OTHERDoraldo-Castelletti scale

During a routine neurological examination, the physician administers the Doraldo-Castelletti scale to the migraine patient. The scale consists of 10 multiple choice questions.

Sponsors

Istituto Auxologico Italiano
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Score of the Doraldo-Castelletti scaleAt baselineScale consisting of 10 multiple choice questions; Minimum score = 0; Maximum score = 13
Proportion of patients referred to physiotherapistAt baselineProportion of patients referred to physiotherapist on the basis of the score of the Doraldo-Castelletti scale

Countries

Italy

Contacts

CONTACTAlberto Doretti, MD
a.doretti@auxologico.it+39-0261911
CONTACTLuca G Grappiolo
luca.grappiolo@auxologico.it+39-0261911

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026