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

NCT04788667 | Completed DMC

• 1 other identifier: Migraine2021
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Migraine

Keywords

chronic migraine; Telerehabilitation; Prophylaxis; Exercise Therapy; Education

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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)

  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)

  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)

  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).

Study Arms (2)

Experimental Group

EXPERIMENTAL

A health education programme using a telerehabilitation platform

Other: A health education programme using a telerehabilitation platform

Control Group

ACTIVE COMPARATOR

General recommendations using a telerehabilitation platform

Other: A health education programme using a telerehabilitation platform

Interventions

A health education programme using a telerehabilitation platform OTHER

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

Also known as: Regular pharmacological treatment provided by their neurologists (Fremanezumab o Erenumab), Regular pharmacological treatment provided by their neurologists (Botulinum Toxin)

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Zaragoza: lead
• Universidad San Jorge: collaborator
• Hospital Clínico Universitario Lozano Blesa: collaborator

Study Sites (1)

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

MeSH Terms

Interventions

Botulinum Toxins

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 9, 2021
• Study Start: April 19, 2021
• Primary Completion: April 22, 2024
• Study Completion: July 26, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

ES (1)