Status:
RECRUITING
Study on 30 Outpatients with Chronic Migraine Treated with Well-Being Therapy or with a Control Therapy
Lead Sponsor:
University of Florence
Conditions:
Chronic Migraine
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Chronic migraine is a disabling type of migraine and is often resistant to treatment. Non-pharmacological interventions have been investigated as potential treatment although, unfortunately, the liter...
Detailed Description
Chronic migraine is a disabling type of migraine and is often resistant to treatment. Non-pharmacological interventions have been investigated as potential treatment although, unfortunately, the liter...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- able and interested in participating to the present research project, as proved by signed Informed consent;
- 18-65 years of age;
- Italian mother tongue;
- diagnosis of chronic migraine according to the International Classification of Headache Disorders. Thus, presenting specific features (i.e., unilateral and pulsating pain of moderate or severe intensity, which is aggravated or precipitated by routine physical activities and is combined with nausea and/or vomiting, photophobia, and phonophobia) and migraine headache on ≥ 15 days per month;
- headache chronicity for a minimum of 1 year and pattern of headache symptoms stable for a period of at least 6 months;
- no pharmacological therapy or dietary supplements use for chronic migraine OR pharmacological therapy/dietary supplement use for chronic migraine stable since at least 3 months;
- psychotropic medication allowed only if stable since at least three months.
- Exclusion criteria:
- diagnosis of medication overuse headache;
- co-occurrence of psychiatric disorder(s) according to the Diagnostic and Statistical Manual of mental disorders (DSM) 5th edition as diagnosed via the MINI International Neuropsychiatric Interview;
- co-occurrence of chronic unstable medical conditions;
- being pregnant or lactating;
- under exogeneous hormones treatment (i.e., hormonal contraceptives, postmenopausal hormone therapy);
- any other condition that, according to the Investigators' opinion, may alter the ability of the patient to follow study procedures.
Exclusion
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03404336
Start Date
October 1 2018
End Date
December 30 2026
Last Update
March 27 2025
Active Locations (2)
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1
Fiammetta COSCI
Florence, Florence, Italy, 50135
2
Centro Cefalee e Farmacologia Clinica
Florence, Italy, Italy