Erzincan Binali Yıldırım Univercity, Medicine Faculty
Erzincan, 24000, Turkey (Türkiye)
NCT Number: NCT07261384
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.
Trial opening soon.
Get Notified18 year–55 year
All sexes
Interventional
Not applicable
Erzincan, 24000, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Baseline and Week 8
Assessment with Manuel compression.
Time frame: Baseline, Week 8
Neck pain intensity will be measured using a 0-10 Visual Analog Scale (VAS) to assess changes over time.
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.
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.
Contact information is provided by the study sponsor or research team.
Yeliz SALCI, Associate Professor
CONTACT
İkra Hatice DİNÇ, MSC
CONTACT
Hacettepe University
Other
"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
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.
Published trials that share one or more normalized conditions with this study.
NCT06828315
Brain Diseases, Central Nervous System Diseases
Muş, Turkey (Türkiye)
View Trial DetailsNCT03768830
Anxiety Disorders, Autoimmune Diseases
Rijeka, Croatia
View Trial DetailsNCT07651839
Anxiety, Anxiety Disorders
View Trial DetailsNCT07479212
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
View Trial Details