Aerobic Exercise and Its Impact on Sensory, Musculoskeletal, and Psychosocial Aspects in Migraine

Not Applicable

Not yet recruiting

• Conditions: Migraine; Aerobic Exercise; Pain Management; Sensory Disorders; Psychosocial Factors; Neck Pain; Quality of Life; Migraine Disease; Migraine Disorder; Migraine Disorders, Brain

• Registration Number: NCT06716489
• Lead Sponsor: University of Sao Paulo

Brief Summary

Migraine is a complex neurological disorder often associated with high levels of disability and alterations in the sensory and musculoskeletal systems. Aerobic exercise is a promising non-pharmacological treatment that may help reduce the frequency and severity of migraine attacks, but its effects on sensory perception and musculoskeletal changes in patients with migraine remain unclear.

This study will evaluate the effects of a 16-week aerobic exercise program on sensory perception, musculoskeletal alterations, and psychosocial factors in women aged 18-40 years old diagnosed with migraine. Participants will undergo assessments of headache-related disability, neck pain, physical fitness, neck performance, balance, and sensory thresholds, among other clinical and physical tests.

The exercise program includes treadmill sessions three times per week, with individualized intensity based on cardiovascular assessments. Expected outcomes include reduced headache disability, improved sensory and musculoskeletal parameters, and improved overall quality of life. This study aims to explore the feasibility of future clinical trials and provide evidence for accessible and low-risk treatment options for migraine management.

Detailed Description

Background: Migraine can be considered a disease of the sensory system. These patients have a high level of disability due to the complexity of the disease. Currently, there are several non-pharmacological treatments, including physical exercise, especially aerobic exercise, which aims to reduce the frequency and intensity of attacks. However, the effects of aerobic exercise on the sensory and musculoskeletal changes that these patients present are not known. Objectives: To examine the effects of an aerobic exercise program on sensory perception, musculoskeletal changes, and psychosocial factors in patients with migraine. Methods: Sixty-eight women diagnosed with migraine between the ages of 18 and 40 will be selected and their anthropometric and clinical characteristics and questionnaires will be collected to assess disability related to headache and neck pain, quality of life, level of physical activity, kinesiophobia, cutaneous allodynia, central sensitization, migraine-related symptoms, self-efficacy and patient perception of global change. Physical tests include assessment of cervical strength, cervical range of motion, cervical endurance, flexion rotation test (FRT), craniocervical flexion test (CCFT), joint position error (JPE), thermal sensitivity threshold and mechanical pain by pressure pain threshold, balance by sensory organization test (SOT), two-point discrimination, Borg scale, and ergospirometry test. A 16-week aerobic training protocol will be performed on a treadmill, 3 times per week, with intensity adjusted for each patient according to cardiovascular assessment. Expected results: The training protocol is expected to be able to reduce headache-related disability, increase sensory thresholds, and improve musculoskeletal changes and overall quality of life in these patients, in addition to verifying the feasibility of conducting a future clinical trial with this group varying the exercise protocol.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-28
• Last Update Submitted: 2024-11-28
• Study Start: 2024-12-01
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Primary Completion: 2028-11
• Study Completion: 2028-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

• Women aged between 18 and 40 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Thermal sensory threshold	16 weeks (the duration of the intervention, with assessments made before and after the 16-week aerobic exercise program).	Thermal sensitivity will be assessed using Quantitative Sensory Testing (QST) equipment (Thermal Sensory Analyzer 2001; Medoc, Ramat Yishai, Israel), which measures sensory thresholds for cold and heat pain in degrees Celsius. A 30x3x30 mm² sensor will be applied under constant pressure to cephalic points of dermatomes V1, V3, and C3 (right and left periorbital regions, mandibular region, and neck at vertebral level C3) and to an extracephalic point in dermatome T1 on the ventral region of the forearm. Data will be reported as the mean change in sensory thresholds (in °C) from baseline to post-intervention.
Pressure pain threshold	16 weeks (measured before and after the 16-week intervention period).	Mechanical pain will be assessed by pressure pain threshold using a digital hand dynamometer adapted for algometry (DDK-20 Kratos®). A constant pressure of 1.0 kg/cm²/s will be applied, with the device ideally positioned perpendicular to the anatomical surfaces assessed at the upper trapezius, temporalis, sternocleidomastoid, suboccipital, anterior scalene and levator scapulae points. Participants will be asked to signal as soon as they feel pain. Both tests will be repeated three times and the individual's average threshold in Kg/F will be calculated.
Cutaneous allodynia	16 weeks (measured before and after the 16-week intervention period).	The severity of cutaneous allodynia will be assessed based on pain and discomfort when carrying out daily activities and measured using the Allodynia Symptom Checklist-12 Items (ASC-12) questionnaire. The maximum score is up to 24 points, obtained from the sum of 12 questions which can be classified as no allodynia (0-2 points), mild allodynia (3-5 points), moderate allodynia (6-8 points) or severe allodynia (9 or more points).
Headache-related disability	16 weeks (measured before and after the 16-week intervention period).	The Headache Impact Test-6 (HIT-6) questionnaire will be used to assess headache-related disability. The participant answers according to a 5-point scale (6= never, 8= rarely, 10= sometimes, 11= often, 13= always). The final score varies between 36 and 78, and is classified as little or no impact (≤49 points), some impact (50-55 points), considerable impact (56-59 points), and severe impact (≥60 points).

Secondary Outcome Measures

Name	Time	Method
Quality of Life	16 weeks (measured before and after the 16-week intervention period).	The Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ) assesses the quality of life of individuals with migraine and is subdivided into three domains: Emotional Function (EF, 5 items), Preventive Function (RF, 7 items) and Social Function (SF, 9 items). The questionnaire is scored by calculating the domains, ranging from 0 (worst quality of life related to migraine) to 100 points (best quality of life related to migraine).
Neck Pain Disability	16 weeks (measured before and after the 16-week intervention period).	The Neck Disability Index (NDI) measures the degree of disability related to neck pain, a very common factor in patients with migraine. It contains 10 questions about the influence of neck pain on daily tasks, such as personal care, sleep and reading. Each item is scored out of a maximum of 5 points and the total score can be the sum of the scores ranging from 0 to 50 points, classifying the individual into: no disability (0 - 4 points), mild disability (5 - 14 points), moderate disability (15 - 24 points), severe disability (25 - 35 points) and total disability (36 or more points).
Physical Activity Level	16 weeks (measured before and after the 16-week intervention period).	The level of physical activity will be measured using the International Physical Activity Questionnaire Short Form (IPAQ-Short Form). There are 7 questions covering four main areas of physical activity: vigorous physical activity, moderate physical activity, walking and sitting time. The questions are open-ended and the individual reports the time spent on each of the tasks. The final IPAC-Short Form score is the sum of the total energy expenditure calculation in Metabolic Equivalent of Task (MET) - minutes per week per domain.
Perceived Global Change	16 weeks (measured after the 16-week intervention period).	At the end of the training, the Patient Global Impression of Change Scale (PGIC) will be applied to capture individuals' personal perception of the improvement or worsening of their clinical condition. It consists of a seven-point scale ranging from much worse, no change to much better, which generates a classification when scored from 0-3 points as deterioration of the disease, 4 points as stable disease or 5-7 points as improvement of the disease).
Self-efficacy	16 weeks (measured before and after the 16-week intervention period).	Patients' self-efficacy will be assessed using the Brazilian version of the Headache Management Self-Efficacy Scale (HMSE-100). The HMSE-10 scale consists of 10 items that assess the individual's perception of their ability to take measures to prevent and manage headache episodes, as well as headache-related disability. Participants will answer the scale items on a 7-point Likert scale, ranging from "strongly disagree" to "strongly agree". The total score will be calculated by adding up the answers, with higher scores indicating greater perceived self-efficacy.
Neck Strength	16 weeks (measured before and after the 16-week intervention period).	Neck strength will be measured using the Multi-Cervical Unit (MCU, BTE technologies, Inc, 2006), a tool that measures the level of strength in kilograms. The subject will be positioned on the device's chair and their head will be held by supports to perform flexion, extension, lateral tilts and rotations. Three repetitions will be performed for each movement and the peak force will be collected after 10 seconds of maximum isometric contraction in Kg/f.
Two-point discrimination test	16 weeks (measured before and after the 16-week intervention period).	The two-point discrimination test on the neck assesses the sensory capacity of the skin to distinguish between two different points when touched simultaneously. To carry out the test, participants will be seated on a bench in front of a table, with their foreheads resting on a folded towel. The third cervical vertebra will be located and marked for evaluation with a ballpoint pen. The assessment will be made from a radius of 2 cm horizontally from the midpoint of the third vertebra, with the intensity standardized up to the first whitening of the skin. The shortest distance in cm at which the patient can discriminate between two different points is recorded, providing a measure of tactile acuity.
Cardiovascular Performance (Cardiopulmonary Exercise Test)	16 weeks (measured before and after the 16-week intervention period).	The ramp protocol will be used for the ergospirometry test to assess cardiorespiratory function and also to adjust the intensity of the participants' aerobic training. The test will be carried out on a treadmill (Super ATL Millenium®, Inbramed/Inbrasport, Porto Alegre, RS, Brazil) and cardiac electrical activity will be measured using an electrocardiogram (ECG) with nine leads (MC5, DI, DII, V1-V6) and oxygen consumption will be monitored using a metabolic analyzer (Ultima™ CardiO2, Medical Graphics Corp., St. Paul, Minneapolis, USA). Exhaled volume (VE), O2 consumed volume (VO2), CO2 exhaled volume (VCO2), metabolic equivalent, VE/VO2 and VE/VCO2 ratio and anaerobic threshold, blood pressure (BP), electrocardiogram, heart rate (HR) and recovery HR at the first, third and sixth minutes will be collected.
Balance (Sensory Organization Test)	16 weeks (measured before and after the 16-week intervention period).	The Sensory Organization Test measures the integration of sensory information from the central nervous system to maintain balance. It is carried out using the Equitest-Neurocom® device, which contains a force platform sensitive to movements, displacements of the center of gravity and a visual camera. The test consists of six different conditions, (1) fixed platform and eyes open, (2) fixed platform and eyes closed, (3) fixed platform and oscillation of the visual camera, (4) moving platform and eyes open, (5) moving platform and eyes closed and (6) moving platform and moving visual camera, which are performed 3 times for 20 seconds. The final score ranges from 0-100, with higher scores indicating better balance.
Kinesiophobia	16 weeks (measured before and after the 16-week intervention period).	The Tampa Scale for Kinesiophobia (TSK) will be used to assess kinesiophobia, that is the aversion to movement. Composed of 17 items, the score varies according to (1) totally disagree, (2) partially disagree, (3) partially agree, and (4) totally agree, with a total score between 17 and 68.
Central sensitization	16 weeks (measured before and after the 16-week intervention period).	Symptoms of central sensitization will be assessed by the Central Sensitization Intentory (CSI), which identifies symptoms related to central sensitization based on two topics subdivided into part A, containing 25 questions that assess the presence and intensity of symptoms associated with central sensitization, and part B, with questions related to the individual's medical history. Part A is made up of a 5-point Likert scale ranging from "0- never" to "4- always" and is scored by the sum of the 25 items ranging from 0-100, obtaining classifications such as 0-29: low probability of central sensitization; 30-39: moderate probability of central sensitization; 40-49: high probability of central sensitization and 50-100: very high probability of central sensitization.
Cervical range of motion	16 weeks (measured before and after the 16-week intervention period).	Cervical range of motion will be measured using the Multi-Cervical Unit (MCU, BTE technologies, Inc, 2006), a tool that measures cervical ROM in degrees. The subject will be positioned on the device's chair and their head will be held by supports to perform flexion, extension, lateral tilts and rotations. For each movement and test, 3 repetitions will be performed, and the ADM will be measured by the maximum movement of the individual without making any compensations. The average of the three repetitions will be used to analyze the results.
Neck endurance	16 weeks (measured before and after the 16-week intervention period).	Neck endurance will be assessed using the Multi-Cervical Unit (MCU, BTE technologies, Inc, 2006), the load will be determined from 25% of the average peak force previously achieved. Participants will be positioned in the same way as for the assessment of cervical strength and ROM. The endurance of the cervical flexor and extensor muscles will be assessed at an interval of three times the endurance time achieved in the assessment, and with a 3-minute interval between flexion and extension. Patients will also be familiarized with the test and instructed to maintain the load targets, which will be provided through visual biofeedback during the assessment. Verbal feedback will be offered to reduce the force if it exceeds 10%, and the test will be stopped if performance falls below 10% of the target due to muscle fatigue or neck pain.
Upper cervical range of motion	16 weeks (measured before and after the 16-week intervention period).	The Flexion Rotation Test (FRT) assesses the mobility of the upper cervical spine, made up of the C1-C2 vertebrae. The test is carried out in the supine position using the Cervical Range of Motion (CROM®) device, which is attached to the participant's head and measures the rotation of the cervical spine in degrees after maximum passive flexion by the evaluator. The FRT is positive for upper vertebral limitation when the result is less than 34°.
Performance of deep flexor cervical muscles	16 weeks (measured before and after the 16-week intervention period).	The Craniocervical Flexion Test measures the ability of the deep flexor muscles of the neck to perform the craniocervical flexion movement and maintain it for 10 seconds. A biofeedback pressure unit measured in millimeters of mercury (mmHg) (Stabilizer Chattanooga South Pacific; USA) is inflated to 20mmHg and the patient, positioned in dorsal decubitus with the unit in the suboccipital region, is asked to perform the subtle movement of yes, without removing the head from contact with the stretcher. The test consists of 5 stages ranging from 22-30mmHg, in which the last stage the patient reaches without compensations is recorded, such as opening the mouth, flexing the neck and contracting the superficial cervical muscles, observed by the evaluator's manual palpation.
Cervical proprioception	16 weeks (measured before and after the 16-week intervention period).	The Cervical Joint Position Error assesses cervical proprioception for flexion, extension and rotation movements. The patient is positioned, with a laser implanted in their head, sitting on a chair 90 cm from a target. The starting point is marked at 0° on the target and the individual is asked to perform the movement to be assessed with their eyes closed and when they return to the final position, the goal being to return to 0°, the distance between the point the participant has reached is assessed in centimeters. Three repetitions are performed and the degrees of positioning error are calculated using the formula: angle= tan-1(positioning error/90 cm). Values of less than 4.5° are considered to be normal cervical proprioception.

Trial Locations

Locations (1)

Ribeirão Preto Medical School - University of São Paulo (FMRP-USP); 🇧🇷 Ribeirao Preto, São Paulo, Brazil