"Personalized Physiotherapy for Migraine: Effects on Pain, Fatigue, and Physical Function" (TIP-MIG)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine
• Intervention / Treatment: Other: Personalized Structured Physiotherapy Intervention; Other: Standard Treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: İKRA HATİCE DİNÇ, MSc; Phone Number: +905374115611; Email: ikrahatice1997@gmail.com
• Study Contact Backup: Name: Yeliz SALCI, Associate Professor; Phone Number: +905303272310; Email: fztyeliz@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Erzincan, Turkey (Türkiye), 24000
    • Erzincan Binali Yıldırım Univercity, Medicine Faculty
    • Contact: İKRA HATİCE DİNÇ, MSc; Phone Number: +905374115611; Email: ikrahatice1997@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity (VAS)	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.	Baseline, Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Frequency (MIDAS A Question)	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.	Baseline and Week 8
Fatigue (Modified Fatigue Impact Scale - MFIS)	Fatigue levels will be measured using the Modified Fatigue Impact Scale (MFIS), which evaluates physical, cognitive, and psychosocial aspects of fatigue.	Baseline and Week 8
Migraine Disability (MIDAS Total Score)	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.	Baseline and Week 8
Quality of Life (Headache Impact Test - HIT-6)	Quality of life will be evaluated using the HIT-6 questionnaire, which measures headache-related impact on daily functioning.	Baseline and Week 8
Craniovertebral Angle (Forward Head Posture)	Forward head posture will be assessed by measuring the craniovertebral angle using a goniometer, with smaller angles indicating more pronounced forward head posture.	Baseline and Week 8
Cervical Range of Motion	Cervical mobility (flexion, extension, lateral flexion, rotation) will be measured with a goniometer to assess changes in cervical spine range of motion.	Baseline and Week 8
Deep Cervical Flexor Muscle Performance	Deep cervical flexor endurance and activation will be assessed using the Stabilizer Pressure Biofeedback Unit during cranio-cervical flexion tasks.	Baseline and Week 8
Trigger Point Tenderness / Pressure Pain Threshold	Assessment with Manuel compression.	Baseline and Week 8
Neck Pain Intensity (VAS)	Neck pain intensity will be measured using a 0-10 Visual Analog Scale (VAS) to assess changes over time.	Baseline, Week 8
Dizziness Handicap (DHI)	Vestibular disability will be assessed with the Dizziness Handicap Inventory (DHI), evaluating functional, emotional, and physical impacts of dizziness.	Baseline and Week 8
Balance (Mini-BESTest)	Balance performance will be evaluated using the Mini-Balance Evaluation Systems Test (Mini-BESTest), which assesses dynamic balance and postural control.	Baseline and Week 8

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: November 22, 2025
• First Submitted That Met QC Criteria: November 22, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Migraine; Fatigue; Physical Function; Individualized Physical Therapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Migraine Disorders; Fatigue
• Other Study ID Numbers: E-10333602-050.04-291274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared. The dataset contains sensitive clinical information, and sharing is not planned. Only aggregated results will be available upon publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No