Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT04788667
Status:
COMPLETED
Last Update Posted:
2024-07-29
First Post:
2021-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of a Health Education Programme for Prevention of Chronic Migraine: A Randomized Clinical Trial
Sponsor:
Universidad de Zaragoza
Organization:
Study Overview
Official Title:
Effectiveness of a Health Education Programme as a Preventive Treatment for Chronic Migraine: A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: