MigraineTIP-MIGNCT07261384
"Personalized Physiotherapy for Migraine: Effects on Pain, Fatigue, and Physical Function"
A study testing Personalized Structured Physiotherapy Intervention and Standard Treatment in people with Migraine, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Migraine
- What is being tested?
- Personalized Structured Physiotherapy Intervention and Standard Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- • 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
Show all 9Show fewer
- Pregnancy or breastfeeding
- Participation in another clinical trial within the last 3 months
- Inability to attend intervention sessions or complete outcome assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Erzincan Binali Yıldırım Univercity, Medicine Faculty
Erzincan, 24000
İKRA HATİCE DİNÇ, MSc, +905374115611, ikrahatice1997@gmail.com
About this study
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"
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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Personalized Structured Physiotherapy Intervention, Standard Treatment
- Keywords
- Migraine, Fatigue, Pain, Physical Function, Individualized Physical Therapy
- Medical subject headings
- Migraine Disorders, Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Structured Physiotherapy InterventionOther
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 TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Structured Physiotherapy Intervention | Experimental | 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 Receives: Other: Personalized Structured Physiotherapy Intervention |
| Standard Treatment | Active comparator | 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. Receives: Other: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 8
Trigger Point Tenderness / Pressure Pain Threshold
Assessment with Manuel compression.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ikra Hatice Dinc, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261384
- Sponsor's protocol ID
- E-10333602-050.04-291274
- Acronym
- TIP-MIG
- Status last verified
- Nov 2025
- First submitted
- 22 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT07261384
- Acronym / sponsor ID
- TIP-MIG / E-10333602-050.04-291274
- Conditions
- Migraine
- Keywords
- Migraine, Fatigue, Pain, Physical Function, Individualized Physical Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Structured Physiotherapy Intervention | Experimental | Other: Personalized Structured Physiotherapy InterventionParticipants 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 |
| Standard Treatment | Active comparator | Other: Standard TreatmentParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged between 18 and 55 years
Key exclusion criteria (9 listed)
- • Presence of other primary headache disorders (cluster headache, tension-type headache as primary diagnosis, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Structured Physiotherapy InterventionThe 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. | Other | Personalized Structured Physiotherapy Intervention |
| Standard TreatmentParticipants 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. | Other | Standard Treatment |
Primary outcome
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Structured Physiotherapy Intervention and Standard Treatment in people with Migraine, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İkra Hatice DİNÇ, MSC (+905374115611, ikrahatice1997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (VAS) (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.