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

  • STATUS
    Recruiting
  • days left to enroll
    82
  • participants needed
    182
  • sponsor
    Universidad de Zaragoza
Updated on 19 April 2022

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.

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.

Details
Condition Chronic Migraine
Treatment A health education programme using a telerehabilitation platform
Clinical Study IdentifierNCT04788667
SponsorUniversidad de Zaragoza
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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