"Investigation of the Effects of Individually Tailored Physiotherapy Approaches on Pain, Fatigue, and Physical Function in Individuals With Migraine: A Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain Intensity (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •• 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
研究组 & 干预措施
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
干预措施: Personalized Structured Physiotherapy Intervention (Other)
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.
干预措施: Standard Treatment (Other)
结局指标
主要结局
Pain Intensity (VAS)
时间窗: 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.
次要结局
- 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)
- Cervical Range of Motion(Baseline and Week 8)
- Deep Cervical Flexor Muscle Performance(Baseline and Week 8)
- Trigger Point Tenderness / Pressure Pain Threshold(Baseline and Week 8)
- Neck Pain Intensity (VAS)(Baseline, Week 8)
- Dizziness Handicap (DHI)(Baseline and Week 8)
- Balance (Mini-BESTest)(Baseline and Week 8)
研究者
Ikra Hatice Dinc
Principal Investigator
Hacettepe University