Migraine, Migraine Disease, Migraine Disorder, Migraine Disorders, Brain, Headache, Headache (Migraine), Headache Disorders, Headache Disorders, Primary, Aerobic Exercise, Pain Management, Sensory Disorders, Psychosocial Factors, Quality of Life
Conditions
Keywords
migraine, aerobic exercise, sensory perception, exercise, headache, disability, musculoeskeletal alterations, quality of life, neck pain, cervical pain, Sensory Thresholds, Psychosocial Factors, Physical Fitness, Exercise Intervention, Central Sensitization, Physical Therapy, Migraine Management, Non-pharmacological Treatment, Clinical Trial, Headache Relief, sensitization
Brief summary
Migraine is a neurological disorder associated with high levels of disability and changes in sensory processing, musculoskeletal function, and psychosocial factors. Aerobic exercise is a low-cost, non-pharmacological strategy that has shown potential benefits for migraine management, but its effects on sensory perception and musculoskeletal function are not yet fully understood. This randomized controlled trial will investigate the effects of a supervised aerobic exercise program combined with pain neuroscience education compared with an active control condition in women aged 18 to 48 years diagnosed with migraine. Participants will be randomly allocated to either an intervention group, which will perform supervised aerobic exercise three times per week for 16 weeks and receive one session of pain neuroscience education, or a control group, which will receive recommendations for unsupervised physical activity at home. Outcomes related to migraine-related disability, self-reported symptoms, sensory sensitivity, and musculoskeletal function will be assessed at baseline and after the intervention period. Questionnaires will also be collected at a 6-month follow-up. The results of this study may contribute to the development of accessible and low-risk non-pharmacological treatment strategies for people with migraine.
Detailed description
Migraine is a complex neurological disorder characterized by sensory dysfunction, musculoskeletal alterations, and psychosocial impairments, often resulting in substantial disability. Although aerobic exercise and pain neuroscience education are recognized as promising non-pharmacological approaches for migraine management, their combined effects on sensory, musculoskeletal, and self-reported outcomes remain insufficiently explored. This study is a randomized controlled trial designed to evaluate the effects of a supervised aerobic exercise program combined with pain neuroscience education compared with an active control condition in women with migraine. A total of 100 participants aged 18 to 48 years with a diagnosis of migraine will be randomly allocated in a 1:1 ratio to either an intervention group or a control group. The intervention group will participate in supervised aerobic exercise sessions performed three times per week for 16 weeks, with exercise intensity individually prescribed based on cardiovascular assessment, and will receive structured pain neuroscience education. The control group will receive recommendations for physical activity to be performed at home without supervision during the same period. Assessments will be conducted at baseline and immediately after the 16-week intervention period. A follow-up assessment at 6 months will include self-reported outcome measures only. Primary and secondary outcomes include migraine-related disability, self-reported symptoms, quality of life, psychosocial factors, sensory sensitivity, and musculoskeletal function, assessed using validated questionnaires and physical tests. The findings of this trial are expected to provide evidence regarding the effectiveness of aerobic exercise combined with pain neuroscience education as a low-risk, accessible treatment strategy for individuals with migraine and to improve understanding of the sensory and musculoskeletal mechanisms involved in this condition.
Interventions
BEHAVIORALSupervised Aerobic Exercise plus Pain Neuroscience Education
This intervention consists of a supervised aerobic exercise program combined with a single session of pain neuroscience education. Aerobic exercise will be performed on a treadmill three times per week for 16 weeks, with intensity individually prescribed based on heart rate reserve. Pain neuroscience education will be delivered in one structured session at the beginning of the intervention, focusing on migraine mechanisms, central sensitization, and the benefits of safe movement.
BEHAVIORALPhysical Activity Recommendations
Participants will receive general recommendations to increase physical activity levels, consisting of either achieving 10,000 steps per day or completing at least 150 minutes of physical activity per week for 16 weeks. No supervision, structured education, or motivational strategies will be provided.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
No
Inclusion criteria
* Women aged between 18 and 48 years. * Diagnosed with migraine by an experienced neurologist specialized in headaches, following the criteria of the International Classification of Headache Disorders (ICHD). * Frequency of headache between 3 and 8 days per month, to ensure adherence to the treatment.
Exclusion criteria
* Presence of any other type of concurrent headache. * Medical conditions affecting sensitivity and autonomic modulation, such as peripheral neuropathies, autonomic disorders, severe neurological diseases, and others. * Conditions that prevent physical activity, such as severe musculoskeletal injuries, cardiovascular diseases, or related conditions. * Premature ovarian failure. * Regular physical exercise in the past year. * Body Mass Index (BMI) above 30.0. * Smokers or individuals using drugs that interfere with sensitivity and cardiac modulation (e.g., beta-blockers). * Abuse of abortive medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache-related disability | 16 weeks (measured before and after the 16-week intervention period). | Headache-related disability will be assessed using the Headache Impact Test-6 (HIT-6), a validated questionnaire that evaluates the impact of headache on daily functioning. The total score ranges from 36 to 78, with higher scores indicating greater headache-related disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pressure pain threshold | 16 weeks (measured before and after the 16-week intervention period). | Mechanical pain sensitivity will be assessed by pressure pain threshold (PPT) using a digital algometer (DDK-20, Kratos®). Pressure will be applied at a constant rate to predefined anatomical sites, including: 1. the cephalic point of the V1 dermatome (periorbital region), 2. the midpoint of the upper trapezius muscle, and 3. an extracranial point corresponding to the L4 dermatome (tibialis anterior muscle), bilaterally. Participants will be instructed to indicate the moment when pressure first becomes painful. Three measurements will be obtained at each site, and the mean value (kgf) will be used for analysis. |
| Self-efficacy | 16 weeks (measured before and after the 16-week intervention period). | Headache-related self-efficacy will be assessed using the 10-item Headache Management Self-Efficacy Scale (HMSE-10). Items are rated on a 7-point Likert scale, and total scores are calculated by summing item responses, with higher scores indicating greater perceived self-efficacy in managing headaches. |
| Cervical range of motion | 16 weeks (measured before and after the 16-week intervention period). | Cervical range of motion (ROM) will be assessed using the Multi-Cervical Unit (MCU; BTE Technologies, Inc.), which measures cervical movement in degrees. Active cervical flexion, extension, lateral flexion, and rotation will be evaluated. For each movement, three trials will be performed, and the mean value will be used for analysis. A composite cervical ROM score, calculated as the sum of all movements, will be used as the outcome measure. |
Countries
Brazil
Contacts
CONTACTAmanda Rodrigues, PhD student
CONTACTDébora Bevilaqua Grossi, PhD
Outcome results
None listed