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.

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Other: Doraldo-Castelletti scale

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.

• Study Type: Interventional
• Enrollment (Estimated): 439
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alberto Doretti, MD; Phone Number: 2937 +39-0261911; Email: a.doretti@auxologico.it
• Study Contact Backup: Name: Luca G Grappiolo; Phone Number: 2894 +39-0261911; Email: luca.grappiolo@auxologico.it

Study Locations

• Italy
  • Milan, Italy, 20149
    • Recruiting
    • Istituto Auxologico Italiano
    • Contact: Alberto Doretti, MD; Phone Number: 2937 +39-0261911; Email: a.doretti@auxologico.it
    • Contact: Email: neurotrial@auxologico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Doraldo Castelletti scale; Migraine patients are the targeted population for administration of the Doraldo-Castelletti scale during a neurological visit	Other: Doraldo-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of the Doraldo-Castelletti scale	Scale consisting of 10 multiple choice questions; Minimum score = 0; Maximum score = 13	At baseline
Proportion of patients referred to physiotherapist	Proportion of patients referred to physiotherapist on the basis of the score of the Doraldo-Castelletti scale	At baseline

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: May 30, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Migraine; Physiotherapy; Neck Disability Index; Headache Impact Test; Neurology visit; Doraldo-Castelletti scale
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 23C513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No