"Personalized Physiotherapy for Migraine: Effects on Pain, Fatigue, and Physical Function"

NCT ID: NCT07261384

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2028-01-30

Brief Summary

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Migraine is a prevalent neurological disorder associated with pain, fatigue, and reduced physical function. The aim of this randomized controlled trial is to examine the effects of a personalized and structured physiotherapy program-including cervical spine stabilization exercises, vestibular rehabilitation, and pain neuroscience education-on pain intensity, fatigue, and functional outcomes in individuals with migraine. Participants will be randomly allocated to an intervention group receiving personalized physiotherapy or a control group receiving standard physiotherapy care. Outcomes will be assessed at baseline, post-intervention, and follow-up.

Detailed Description

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Migraine is a disabling primary headache disorder characterized by recurrent attacks and frequently accompanied by cervical musculoskeletal dysfunction, vestibular symptoms, and altered pain processing mechanisms. Current evidence suggests that physiotherapy interventions targeting manual therapy, cervical stabilization, vestibular function, and pain neuroscience education may positively influence migration-related outcomes; However, studies combining these components in a personalized treatment model are limited.

This randomized controlled trial aims to investigate the effectiveness of a personalized structured physiotherapy program designed specifically for individuals with migraine. The interventions will include manual therapy, cervical spine stabilization exercises, vestibular rehabilitation strategies, and pain neuroscience education delivered by a physiotherapist. The control group will receive only pain neuroscience education.

Primary outcomes will include pain intensity and frequency. Secondary outcomes will include fatigue, disability level, cervical function, physical performance, and patient-reported functional limitations. Assessments will be conducted at baseline, immediately post-intervention, and during a follow-up period. The findings are expected to contribute to evidence-based physiotherapy approaches for migraine management.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Personalized Structured Physiotherapy Intervention

Participants will receive a personalized, structured physiotherapy program including manual therapy, cervical spine stabilization exercises, vestibular rehabilitation exercises, and pain neuroscience education. The intervention will be delivered by a licensed physiotherapist twice weekly for 8 weeks.

The manual therapy will include component, applied according to individual patient needs to reduce pain, improve mobility, and modulate neuromuscular control.

The cervical spine stabilization exercises will target deep neck flexors and cervical postural muscles to improve neuromuscular control, endurance, and motor coordination.

The vestibular rehabilitation component will include gaze stabilization, habituation, and balance exercises tailored to migraine-related vestibular symptoms.

The PNE program will consist of structured individual education sessions focusing on pain neurobiology, central sensitization, and self-management strategies.

Participants will attend supervised physio

Group Type EXPERIMENTAL

Personalized Structured Physiotherapy Intervention

Intervention Type OTHER

The manual therapy will include component, applied according to individual patient needs to reduce pain, improve mobility, and modulate neuromuscular control.

The cervical spine stabilization exercises will target deep neck flexors and cervical postural muscles to improve neuromuscular control, endurance, and motor coordination.

The vestibular rehabilitation component will include gaze stabilization, habituation, and balance exercises tailored to migraine-related vestibular symptoms.

The PNE program will consist of structured individual education sessions focusing on pain neurobiology, central sensitization, and self-management strategies.

Participants will attend supervised physiotherapy sessions twice weekly for 8 weeks, complemented by a personalized home exercise program. All components will be delivered by a licensed physiotherapist.

Standard Treatment

Participants will continue their routine migraine care, including any pharmacological treatment. During the 8-week study period, they will receive only two 40-minute Pain Neuroscience Education sessions. No additional physiotherapy or exercise interventions.

Group Type ACTIVE_COMPARATOR

Standard Treatment

Intervention Type OTHER

Participants continue routine care including medications prescribed by their physician. Only two 40-minute Pain Neuroscience Education sessions over 8 weeks. No physiotherapy or exercise intervention provided.

Interventions

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Personalized Structured Physiotherapy Intervention

The manual therapy will include component, applied according to individual patient needs to reduce pain, improve mobility, and modulate neuromuscular control.

The cervical spine stabilization exercises will target deep neck flexors and cervical postural muscles to improve neuromuscular control, endurance, and motor coordination.

The vestibular rehabilitation component will include gaze stabilization, habituation, and balance exercises tailored to migraine-related vestibular symptoms.

The PNE program will consist of structured individual education sessions focusing on pain neurobiology, central sensitization, and self-management strategies.

Participants will attend supervised physiotherapy sessions twice weekly for 8 weeks, complemented by a personalized home exercise program. All components will be delivered by a licensed physiotherapist.

Intervention Type OTHER

Standard Treatment

Participants continue routine care including medications prescribed by their physician. Only two 40-minute Pain Neuroscience Education sessions over 8 weeks. No physiotherapy or exercise intervention provided.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged between 18 and 55 years

* Diagnosed with migraine according to the International Classification of Headache Disorders - 3rd edition (ICHD-3) criteria
* Experiencing 2-8 migraine attacks per month in the last 3 months
* Able to participate in an 8-week physiotherapy intervention program
* Able to understand instructions and provide written informed consent
* Stable medication use for migraine for at least 1 month prior to participation (no changes planned during study period)

Exclusion Criteria

* • Presence of other primary headache disorders (cluster headache, tension-type headache as primary diagnosis, etc.)

* Neurological diseases (epilepsy, stroke, multiple sclerosis)
* Vestibular disorders unrelated to migraine
* Cervical radiculopathy, myelopathy, or severe cervical spine pathology
* History of neck surgery or significant cervical trauma
* Severe musculoskeletal conditions affecting posture or cervical function
* Pregnancy or breastfeeding
* Participation in another clinical trial within the last 3 months
* Inability to attend intervention sessions or complete outcome assessments
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Ikra Hatice Dinc

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Erzincan Binali Yıldırım Univercity, Medicine Faculty

Erzincan, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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İkra Hatice DİNÇ, MSC

Role: CONTACT

+905374115611

Yeliz SALCI, Associate Professor

Role: CONTACT

+905303272310

Facility Contacts

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İKRA HATİCE DİNÇ, MSc

Role: primary

+905374115611

Other Identifiers

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E-10333602-050.04-291274

Identifier Type: -

Identifier Source: org_study_id

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