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Recruiting NCT07626307

NCT07626307 Evaluation of the Performance of the Doraldo-Castelletti Scale in Supporting the Neurologist's Decision to Refer Migraine Patients to Physiotherapy

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Clinical Trial Summary
NCT ID NCT07626307
Status Recruiting
Phase —
Sponsor Istituto Auxologico Italiano
Condition Migraine
Study Type INTERVENTIONAL
Enrollment 439 participants
Start Date 2025-11-20
Primary Completion 2027-10-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 70 Years
Study Type INTERVENTIONAL
Interventions
Doraldo-Castelletti scale

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 439 participants in total. It began in 2025-11-20 with a primary completion date of 2027-10-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Alberto Doretti, MD

✉ a.doretti@auxologico.it

📞 +39-0261911

Frequently Asked Questions

Who can join the NCT07626307 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07626307 currently recruiting?

Yes, NCT07626307 is actively recruiting participants. Contact the research team at a.doretti@auxologico.it for enrollment information.

Where is the NCT07626307 trial being conducted?

This trial is being conducted at Milan, Italy.

Who is sponsoring the NCT07626307 clinical trial?

NCT07626307 is sponsored by Istituto Auxologico Italiano. The trial plans to enroll 439 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: November 2026  ·  Data Methodology