Effectiveness of a Health Education Programme for Prevention of Chronic Migraine: A Randomized Clinical Trial
Primary Purpose
Chronic Migraine
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
A health education programme using a telerehabilitation platform
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Migraine focused on measuring chronic migraine, Telerehabilitation, Prophylaxis, Exercise Therapy, Education
Eligibility Criteria
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.
Sites / Locations
- Hospital Clínico Universitario Lozano BlesaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control Group
Arm Description
A health education programme using a telerehabilitation platform
General recommendations using a telerehabilitation platform
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Analgesic medication
Analgesic medication use (days/month).
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.
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.
Allodynia Symptom Checklist (ASC-12)
Changes in allodynia. ASC-12 assess frequency of cutaneous allodynia symptoms during headache attack, including 12 questions.
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).
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.
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.
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.
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).
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).
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.
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).
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).
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).
Full Information
NCT ID
NCT04788667
First Posted
March 4, 2021
Last Updated
May 10, 2023
Sponsor
Universidad de Zaragoza
Collaborators
Universidad San Jorge, Hospital Clínico Universitario Lozano Blesa
1. Study Identification
Unique Protocol Identification Number
NCT04788667
Brief Title
Effectiveness of a Health Education Programme for Prevention of Chronic Migraine: A Randomized Clinical Trial
Official Title
Effectiveness of a Health Education Programme as a Preventive Treatment for Chronic Migraine: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza
Collaborators
Universidad San Jorge, Hospital Clínico Universitario Lozano Blesa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine
Keywords
chronic migraine, Telerehabilitation, Prophylaxis, Exercise Therapy, Education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
182 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
A health education programme using a telerehabilitation platform
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
General recommendations using a telerehabilitation platform
Intervention Type
Other
Intervention Name(s)
A health education programme using a telerehabilitation platform
Other Intervention Name(s)
Regular pharmacological treatment provided by their neurologists (Fremanezumab o Erenumab), Regular pharmacological treatment provided by their neurologists (Botulinum Toxin)
Intervention Description
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
Primary Outcome Measure Information:
Title
Headache frequency (days/month)
Description
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.
Time Frame
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 Measure Information:
Title
Headache intensity
Description
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.
Time Frame
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).
Title
Analgesic medication
Description
Analgesic medication use (days/month).
Time Frame
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).
Title
The six-item Headache Impact Test (HIT-6)
Description
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.
Time Frame
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).
Title
Migraine Disability Assessment (MIDAS)
Description
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.
Time Frame
pre-intervention (day 1), month 3, month 6 (post-intervention), month 9 (follow-up 2), month 12 (follow-up 3).
Title
Allodynia Symptom Checklist (ASC-12)
Description
Changes in allodynia. ASC-12 assess frequency of cutaneous allodynia symptoms during headache attack, including 12 questions.
Time Frame
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).
Title
Pressure pain threshold (PPT)
Description
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).
Time Frame
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).
Title
Temporal summation (TS)
Description
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.
Time Frame
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).
Title
Hospital Anxiety and Depression (HADS)
Description
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.
Time Frame
pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
Title
Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
Title
Tampa Scale for Kinesiophobia (TSK)
Description
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).
Time Frame
pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
Title
International physical activity questionnaire (IPAQ) short-form.
Description
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).
Time Frame
pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
Title
Pittsburg Sleep Quality Index (PSQI)
Description
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.
Time Frame
pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
Title
Chronic Pain Self-efficacy Scale
Description
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).
Time Frame
pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
Title
Satisfaction scale
Description
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).
Time Frame
month 6 (post-intervention).
Title
Pollutants
Description
Pollutants measured through a wearable. It will measure different pollutants such as particulate matter (PM), ozone (O3), nitrogen dioxide (NO2) and sulphur dioxide (SO2).
Time Frame
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pablo Herrero, PhD
Phone
+34646168248
Email
pherrero@unizar.es
First Name & Middle Initial & Last Name or Official Title & Degree
Pablo Herrero, PhD
Phone
+34 646168248
Facility Information:
Facility Name
Hospital Clínico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Santos, MD
First Name & Middle Initial & Last Name & Degree
Sonia Santos, MD
First Name & Middle Initial & Last Name & Degree
María Pilar Navarro, MD
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of a Health Education Programme for Prevention of Chronic Migraine: A Randomized Clinical Trial
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