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NCT07626307Recruiting

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)

Source: ClinicalTrials.gov · Last updated 4 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
439 (estimated)
First submitted
29 May 2026
Start date
20 Nov 2025
Primary completion date
1 Oct 2027
Lead sponsor
Istituto Auxologico Italiano
Diseases
Migraine
NCT number
NCT07626307

What you commit to

  • Study type: Interventional
  • Planned participants: 439
  • From 20 Nov 2025 to the primary completion date, 1 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous physiotherapy treatments specifically for headache management
  • Previous neurosurgical interventions involving the cervical region

Other illness

  • Neurological diseases confounding the primary objective
  • Conditions confounding the primary objective (e.g., fibromyalgia, which could limit patient evaluation by the physiotherapist)
  • 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
  • Any condition deemed contraindicating study participation according to the investigator's judgment

Who the study is looking for

  • 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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Istituto Auxologico Italiano
Coordinator of this site? Confirm its status
MilanItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.