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NCT Number: NCT07261384

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erzincan Binali Yıldırım Univercity, Medicine Faculty

Erzincan, 24000, Turkey (Türkiye)

Location contact

İKRA HATİCE DİNÇ, MSc

CONTACT

[email protected]

+905374115611

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalized Structured Physiotherapy Intervention

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

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.

Primary outcomes

  1. Pain Intensity (VAS)

    Time frame: Baseline, Week 8

    Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Measurements will be taken at baseline, and at the completion of the 8-week intervention.

Secondary outcomes

  1. Pain Frequency (MIDAS A Question)

    Time frame: Baseline and Week 8

    Pain frequency will be assessed using Question A of the Migraine Disability Assessment Questionnaire (MIDAS), which evaluates the number of headache days over the previous 3 months.

  2. Fatigue (Modified Fatigue Impact Scale - MFIS)

    Time frame: Baseline and Week 8

    Fatigue levels will be measured using the Modified Fatigue Impact Scale (MFIS), which evaluates physical, cognitive, and psychosocial aspects of fatigue.

  3. Migraine Disability (MIDAS Total Score)

    Time frame: Baseline and Week 8

    Migraine-related disability will be assessed with the MIDAS total score, which quantifies the impact of migraine on daily activities over the past 3 months.

  4. Quality of Life (Headache Impact Test - HIT-6)

    Time frame: Baseline and Week 8

    Quality of life will be evaluated using the HIT-6 questionnaire, which measures headache-related impact on daily functioning.

  5. Craniovertebral Angle (Forward Head Posture)

    Time frame: Baseline and Week 8

    Forward head posture will be assessed by measuring the craniovertebral angle using a goniometer, with smaller angles indicating more pronounced forward head posture.

  6. Cervical Range of Motion

    Time frame: Baseline and Week 8

    Cervical mobility (flexion, extension, lateral flexion, rotation) will be measured with a goniometer to assess changes in cervical spine range of motion.

  7. Deep Cervical Flexor Muscle Performance

    Time frame: Baseline and Week 8

    Deep cervical flexor endurance and activation will be assessed using the Stabilizer Pressure Biofeedback Unit during cranio-cervical flexion tasks.

  8. Trigger Point Tenderness / Pressure Pain Threshold

    Time frame: Baseline and Week 8

    Assessment with Manuel compression.

  9. Neck Pain Intensity (VAS)

    Time frame: Baseline, Week 8

    Neck pain intensity will be measured using a 0-10 Visual Analog Scale (VAS) to assess changes over time.

  10. Dizziness Handicap (DHI)

    Time frame: Baseline and Week 8

    Vestibular disability will be assessed with the Dizziness Handicap Inventory (DHI), evaluating functional, emotional, and physical impacts of dizziness.

  11. Balance (Mini-BESTest)

    Time frame: Baseline and Week 8

    Balance performance will be evaluated using the Mini-Balance Evaluation Systems Test (Mini-BESTest), which assesses dynamic balance and postural control.

Study contacts

Contact information is provided by the study sponsor or research team.

Yeliz SALCI, Associate Professor

CONTACT

[email protected]

+905303272310

İkra Hatice DİNÇ, MSC

CONTACT

[email protected]

+905374115611

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Acronym: TIP-MIG

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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