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NCT Number: NCT07626307

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doraldo-Castelletti scale

Other

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

Primary outcomes

  1. Score of the Doraldo-Castelletti scale

    Time frame: At baseline

    Scale consisting of 10 multiple choice questions; Minimum score = 0; Maximum score = 13

  2. Proportion of patients referred to physiotherapist

    Time frame: At baseline

    Proportion of patients referred to physiotherapist on the basis of the score of the Doraldo-Castelletti scale

Study contacts

Contact information is provided by the study sponsor or research team.

Alberto Doretti, MD

CONTACT

[email protected]

+39-0261911 ext. 2937

Luca G Grappiolo

CONTACT

[email protected]

+39-0261911 ext. 2894

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

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)

Acronym: MIGSKA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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