Clinical trial NCT04788667: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Migraine
Keywords: chronic migraine
Telerehabilitation
Prophylaxis
Exercise Therapy
Education
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
Collaborators: name: Universidad San Jorge
name: Hospital Clínico Universitario Lozano Blesa
First posted: 2021-03-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Headache frequency (days/month)
timeFrame: 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:
measure: Headache intensity
timeFrame: 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).
measure: Analgesic medication
timeFrame: 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).
measure: The six-item Headache Impact Test (HIT-6)
timeFrame: 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).
measure: Migraine Disability Assessment (MIDAS)
timeFrame: pre-intervention (day 1), month 3, month 6 (post-intervention), month 9 (follow-up 2), month 12 (follow-up 3).
measure: Allodynia Symptom Checklist (ASC-12)
timeFrame: 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).
measure: Pressure pain threshold (PPT)
timeFrame: 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).
measure: Temporal summation (TS)
timeFrame: 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).
measure: Hospital Anxiety and Depression (HADS)
timeFrame: pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
measure: Pain Catastrophizing Scale (PCS)
timeFrame: pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
measure: International physical activity questionnaire (IPAQ) short-form.
timeFrame: pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
measure: Chronic Pain Self-efficacy Scale
timeFrame: pre-intervention (day 1), month 3, month 6 (post-intervention), month 12 (follow-up 3).
measure: Satisfaction scale
timeFrame: month 6 (post-intervention).
measure: Pollutants
timeFrame: 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).
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
Study officials:
References: