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

Study Overview
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Brief Summary
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Chronic migraine (CM) is a common and frequent disorder, which has a major impact on the quality of life of migraine sufferers, interfering with physical function, productivity at work, personal life and leisure, lifestyle and psychological well-being. The use of a prophylactic drug treatment is recommended if headache is present more than 8 days per month. In addition, several studies have shown benefits of non-pharmacological interventions such as self-management strategies, manual therapy and exercise. However, no studies have been found that analyse the beneficial effect of a combination of a preventive drug treatment and a health education programme. Thus, this project would offer a service of health education through a telerehabilitation programme for patients with chronic migraine under prophylactic drug treatment. The aim of this study is to compare the combination of a prophylactic drug therapy and a health education programme in the preventive treatment of patients with chronic migraine.based on the hypothesis that a health education program for chronic migraine patients could decrease the number of migraine days.

Detailed Description
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Design: A randomised, double-blind, controlled clinical trial will be conducted in two parallel groups, in which all patients with migraine chronic are receiving prophylactic drug treatment with Fremanezumab or Erenumab as prescribed by a physician. Moreover, patients in the experimental group will receive a health education programme and patients in the control group will receive a programme of general recommendations. Intervention: A 4-week baseline data collection period is included to record the frequency and intensity of migraine pain before starting the study. The intervention will be carried out for 6 months with a follow-up at 1, 3 and 12 months. Experimental group: Patients will receive health education through video-tutorials that can be watched on the HEFORA platform. Each video-tutorial will contain the content of an educational session, including health information in the areas of pain education, migraine neurophysiology, relaxation techniques, sleep habits, eating habits, physical exercise, coping strategies and emotion management. Control group: Patients will receive video-tutorials with general recommendations though HEFORA platform.

Official Title
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Effectiveness of a Health Education Programme as a Preventive Treatment for Chronic Migraine: A Randomized Clinical Trial

Conditions
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Chronic Migraine

Intervention / Treatment
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* Other: A health education programme using a telerehabilitation platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range 18-65 years. Patients diagnosed with CM following the ICHD-III criteria. Patients with migraine onset before the age of 50 years. Patients who have been diagnosed with chronic migraine for at least 1 year. Exclusion Criteria: Women who are pregnant or breastfeeding. Women with menstrual migraine. Patients with severe or unstable psychiatric pathology that contraindicates the use of drug treatment. Allergic patients or those who show sensitivity to components of the drug treatment. Patients who refuse to sign the informed consent form or to participate in the study. Patients who decide not to continue in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>A health education programme using a telerehabilitation platform | Other: A health education programme using a telerehabilitation platform<br>* All patients enrolled in the study will receive information through the tele rehabilitation platform, although the experimental group will have specific training/education whereas the control group will only receive some general recommendations as control/sham<br>* Other names: Regular pharmacological treatment provided by their neurologists (Botulinum Toxin);|
| Active Comparator: Control Group<br>General recommendations using a telerehabilitation platform | Other: A health education programme using a telerehabilitation platform<br>* All patients enrolled in the study will receive information through the tele rehabilitation platform, although the experimental group will have specific training/education whereas the control group will only receive some general recommendations as control/sham<br>* Other names: Regular pharmacological treatment provided by their neurologists (Botulinum Toxin);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache frequency (days/month) | 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. | baseline (30 days after intervention), month 1, month 2, month 3, month 4, month 5, month 6 (post-intervention), month 7 (follow-up 1), month 9 (follow-up 2), month 12 (follow-up 3). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache intensity | 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. | baseline (30 days after intervention), month 1, month 2, month 3, month 4, month 5, month 6 (post-intervention), month 7 (follow-up 1), month 9 (follow-up 2), month 12 (follow-up 3). | 
| Analgesic medication | Analgesic medication use (days/month). | baseline (30 days after intervention), month 1, month 2, month 3, month 4, month 5, month 6 (post-intervention), month 7 (follow-up 1), month 9 (follow-up 2), month 12 (follow-up 3). | 
| The six-item Headache Impact Test (HIT-6) | 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. | pre-intervention (day 1), month 1, month 2, month 3, month 4, month 5, month 6 (post-intervention), month 7 (follow-up 1), month 9 (follow-up 2), month 12 (follow-up 3). | 
| Migraine Disability Assessment (MIDAS) | 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. | pre-intervention (day 1), month 3, month 6 (post-intervention), month 9 (follow-up 2), month 12 (follow-up 3). | 
| Allodynia Symptom Checklist (ASC-12) | Changes in allodynia. ASC-12 assess frequency of cutaneous allodynia symptoms during headache attack, including 12 questions. | pre-intervention (day 1), month 3, month 6 (post-intervention), month 7 (follow-up 1), month 9 (follow-up 2), month 12 (follow-up 3). | 
| Pressure pain threshold (PPT) | 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). | pre-intervention (day 1), month 3, month 6 (post-intervention), month 7 (follow-up 1), month 9 (follow-up 2), month 12 (follow-up 3). | 
| Temporal summation (TS) | 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. | pre-intervention (day 1), month 3, month 6 (post-intervention), month 7 (follow-up 1), month 9 (follow-up 2), month 12 (follow-up 3). | 
| Hospital Anxiety and Depression (HADS) | 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. | pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3). | 
| Pain Catastrophizing Scale (PCS) | 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. | pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3). | 
| Tampa Scale for Kinesiophobia (TSK) | 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). | pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3). | 
| International physical activity questionnaire (IPAQ) short-form. | 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). | pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3). | 
| Pittsburg Sleep Quality Index (PSQI) | 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. | pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3). | 
| Chronic Pain Self-efficacy Scale | 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). | pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3). | 
| Satisfaction scale | 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). | month 6 (post-intervention). | 
| Pollutants | Pollutants measured through a wearable. It will measure different pollutants such as particulate matter (PM), ozone (O3), nitrogen dioxide (NO2) and sulphur dioxide (SO2). | baseline (30 days after intervention), before intervention, month 1, month 2, month 3, month 4, month 5, month 6 (post-intervention), month 7 (follow-up 1), month 9 (follow-up 2), month 12 (follow-up 3). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic migraine, Telerehabilitation, Prophylaxis, Exercise Therapy, Education