Chronic MigraineNCT04788667
Effectiveness of a Health Education Programme for Prevention of Chronic Migraine: A Randomized Clinical Trial
A study testing A health education programme using a telerehabilitation platform in people with Chronic Migraine, run by Universidad de Zaragoza at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- A health education programme using a telerehabilitation platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 19 Apr 2021to 26 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Health Education Programme as a Preventive Treatment for Chronic Migraine: A Randomized Clinical Trial
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.
Read more
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.
Read the 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.
- Conditions
- Chronic Migraine
- Being tested
- A health education programme using a telerehabilitation platform
- Keywords
- chronic migraine, Telerehabilitation, Prophylaxis, Exercise Therapy, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A health education programme using a telerehabilitation platformOther
Also called Regular pharmacological treatment provided by their neurologists (Fremanezumab o Erenumab), Regular pharmacological treatment provided by their neurologists (Botulinum Toxin)
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | A health education programme using a telerehabilitation platform Receives: Other: A health education programme using a telerehabilitation platform |
| Control Group | Active comparator | General recommendations using a telerehabilitation platform Receives: Other: A health education programme using a telerehabilitation platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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).
Secondary outcomes (15)
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.
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).
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).
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.
Measured: 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.
Measured: 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.
Measured: 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:
- 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start19 Apr 2021
- Primary completion22 Apr 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad San Jorge, Hospital Clínico Universitario Lozano Blesa
- Responsible party
- Principal investigator, Dr. Pablo Herrero Gallego, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788667
- Sponsor's protocol ID
- Migraine2021
- Status last verified
- Jul 2024
- First submitted
- 4 Mar 2021
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Health Education Programme as a Preventive Treatment for Chronic Migraine: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04788667
- Acronym / sponsor ID
- Migraine2021
- Conditions
- Chronic Migraine
- Keywords
- chronic migraine, Telerehabilitation, Prophylaxis, Exercise Therapy, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Collaborators
- Universidad San Jorge, Hospital Clínico Universitario Lozano Blesa
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: A health education programme using a telerehabilitation platformA health education programme using a telerehabilitation platform |
| Control Group | Active comparator | Other: A health education programme using a telerehabilitation platformGeneral recommendations using a telerehabilitation platform |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A health education programme using a telerehabilitation platformAlso: Regular pharmacological treatment provided by their neurologists (Fremanezumab o Erenumab), Regular pharmacological treatment provided by their neurologists (Botulinum Toxin)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 | Other | Control Group, Experimental Group |
Primary outcome
Headache frequency (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).
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.
15 secondary outcomes
Headache intensity
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).
Analgesic medication
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).
The six-item Headache Impact Test (HIT-6)
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).
Migraine Disability Assessment (MIDAS)
Time frame: 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)
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).
Pressure pain threshold (PPT)
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).
Temporal summation (TS)
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).
Hospital Anxiety and Depression (HADS)
Time frame: pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
Pain Catastrophizing Scale (PCS)
Time frame: pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
Tampa Scale for Kinesiophobia (TSK)
Time frame: pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
International physical activity questionnaire (IPAQ) short-form.
Time frame: pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
Pittsburg Sleep Quality Index (PSQI)
Time frame: pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
Chronic Pain Self-efficacy Scale
Time frame: pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
Satisfaction scale
Time frame: month 6 (post-intervention).
Pollutants
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A health education programme using a telerehabilitation platform in people with Chronic Migraine, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache frequency (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.