Effectiveness of a Health Education Programme for Prevention of Chronic Migraine: A Randomized Clinical Trial

Changes in number of days/month of headache following the criteria of "The International Classification of Headache Disorders (ICHD-III). Headache frequency will be assessed with a headache diary.

Changes in intensity of headache: 0, (no pain), 1 (mild), 2 (moderate) and 3 (intense).

Both the maximum pain and the average pain for the month will be measured.

Analgesic medication use (days/month).

Changes in the impact of headache. The HIT-6 measures the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning and psychological distress. The HIT-6 also measures the severity of headache pain. Each item is answered on a 5-point Likert scale (6 = never, 8 = rarely, 10 = sometimes, 11 = very often, 13 = always). The final score is obtained from simple summation of the six items.

Changes in headache-related disability. MIDAS questionnaire is a brief, self-administered questionnaire designed to quantify headache-related disability over a 3 month period. Once scored, the test gives the patient an idea of how debilitating his/her migraines are based on this scale: 0 to 5, MIDAS Grade I, Little or no disability; 6 to 10, MIDAS Grade II, Mild disability; 11 to 20, MIDAS Grade III, Moderate disability; 21+, MIDAS Grade IV, Severe disability.

Changes in allodynia. ASC-12 assess frequency of cutaneous allodynia symptoms during headache attack, including 12 questions.

Changes in PPT using an algometer (Wagner, FDX). To determine PPT, pressure was increased at a rate of approximately 1 kg/s and subjects were asked to say 'pain' at the point the sensation first became painful, at which point pressure was released and the readout recorded. Thresholds were taken as the average of two measures taken 30 s apart.

• 21 scalp points used in the international standard of encephalography:

o Fp2, Fp4, F8, C4, T4, P4, T6, C2, Fp1, F3, F7, C3, T3, P3, T5 y O1, Fpz, Fz, Cz, Pz y Oz.

• Upper trapezius, bilaterally (midpoint between the C7 spine and the acromion).
• Suboccipital area, bilaterally (the insertion of the suboccipital and upper trapezius muscle).
• Control point, bilaterally (distally located in the muscle belly of the medial gastrocnemius).

Changes in TS using Pin-Prick. The temporal summation assessment will be performed using a 256 mN "Pin-Prick" by performing 10 consecutive pressures of one second each with a pause interval of one second. The patient will then evaluate the intensity of pain on a visual analogue scale. It will be applied on a single point of the upper trapezius muscle.

Changes in depression and anxiety. The questionnaire comprises seven questions for anxiety and seven questions for depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.

Changes in catastrophism. The PCS is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time). The PCS is broken into three subscales being magnification, rumination, and helplessness.

Changes in kinesiophobia. TSK abbreviated version is 11 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance, scoring range from 1 (strongly disagree) to 4 (strongly agree).

Changes in physical activity. The IPAQ short-form consists of 8 items to estimate the time spent performing physical activities (moderate to vigorous) and inactivity (time spent sitting).

Changes in sleep quality. The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points.

Changes in self-efficacy. The 19-item Chronic Pain Self-efficacy Scale (CPSS) measures three domains of pain self-efficacy: pain management, physical functioning, and coping with symptoms. It consists of a Likert-type scale ranging from 0 (=I see myself as totally incapable) to 10 (=I see myself as totally capable).

Changes in satisfaction. A 5-point Likert-type scale will be used (1= Very dissatisfied; 2= Somewhat dissatisfied; 3=Indifferent; 4= Somewhat satisfied; 5= Very satisfied).

Pollutants measured through a wearable. It will measure different pollutants such as particulate matter (PM), ozone (O3), nitrogen dioxide (NO2) and sulphur dioxide (SO2).