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

Official title

"Investigation of the Effects of Individually Tailored Physiotherapy Approaches on Pain, Fatigue, and Physical Function in Individuals With Migraine: A Randomized Controlled Trial"

Overview

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

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.

Interventions

• Other 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
• 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.

Primary outcome measures

• Pain Intensity (VAS) [Time frame: Baseline, Week 8]

Secondary outcome measures (11)

• Pain Frequency (MIDAS A Question) [Time frame: Baseline and Week 8]
• Fatigue (Modified Fatigue Impact Scale - MFIS) [Time frame: Baseline and Week 8]
• Migraine Disability (MIDAS Total Score) [Time frame: Baseline and Week 8]
• Quality of Life (Headache Impact Test - HIT-6) [Time frame: Baseline and Week 8]
• Craniovertebral Angle (Forward Head Posture) [Time frame: Baseline and Week 8]
• Cervical Range of Motion [Time frame: Baseline and Week 8]
• Deep Cervical Flexor Muscle Performance [Time frame: Baseline and Week 8]
• Trigger Point Tenderness / Pressure Pain Threshold [Time frame: Baseline and Week 8]
• Neck Pain Intensity (VAS) [Time frame: Baseline, Week 8]
• Dizziness Handicap (DHI) [Time frame: Baseline and Week 8]
• Balance (Mini-BESTest) [Time frame: Baseline and Week 8]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Erzincan Binali Yıldırım Univercity, Medicine Faculty — Erzincan

Identifiers

NCT: NCT07261384 · E-10333602-050.04-291274

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗