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

NCT07261384 | Not Yet Recruiting

• 1 other identifier: E-10333602-050.04-291274
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Migraine

Keywords

Migraine; Fatigue; Pain; Physical Function; Individualized Physical Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Pain Frequency (MIDAS A Question)

  Baseline and Week 8

• Fatigue (Modified Fatigue Impact Scale - MFIS)

  Baseline and Week 8

• Migraine Disability (MIDAS Total Score)

  Baseline and Week 8

• Quality of Life (Headache Impact Test - HIT-6)

  Baseline and Week 8

• Craniovertebral Angle (Forward Head Posture)

  Baseline and Week 8

Study Arms (2)

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

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.

Other: Standard Treatment

Interventions

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.

Personalized Structured Physiotherapy Intervention

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.

Standard Treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Erzincan Binali Yıldırım Univercity, Medicine Faculty

Erzincan, 24000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders; Fatigue; Pain

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Central Study Contacts

İkra Hatice DİNÇ, MSC

CONTACT

+905374115611; ikrahatice1997@gmail.com

Yeliz SALCI, Associate Professor

CONTACT

+905303272310; fztyeliz@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)