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

University of Zaragoza

Status: Completed

Conditions: Chronic Migraine

Treatments: Other: A health education programme using a telerehabilitation platform

Study type: Interventional

Funder types: Other

Identifiers

NCT04788667

Migraine2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

48 participants in 2 patient groups

Experimental Group

Experimental group

Description:

A health education programme using a telerehabilitation platform

Treatment:

Other: A health education programme using a telerehabilitation platform

Control Group

Active Comparator group

Description:

General recommendations using a telerehabilitation platform

Treatment:

Other: A health education programme using a telerehabilitation platform