Mesotherapy Versus Systemic Therapyin Treatment of Migraine Headache

Study Overview
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Brief Summary
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Introduction:Migraine is a prevalent disabling primary headache disorder which is classified in two major types; migraine without aura and migraine with aura. The aim of this study was to compare the efficiency of mesotherapy with systemic therapy in pain controlin patients with headache related tomigraine without aura. Methods: We conducted this prospective parallel randomized controlled trial with the patients admitted to the emergency department with headache related to migraine without aura. One group was treated with mesotherapy, and the control group with intravenous dexketoprofen. Changes in pain intensity at 30th minute, 60th minute, 120th minute and 24th hours after treatment using Visual Analogue Scale (VAS), need to use analgesic drug within 24 hours,re-admission with same complaint to emergency department (ED) within 72 hours, and adverse effect rate of the methods were compared between groups.

Official Title
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Comparison of Intradermal Mesotherapy With Systemic Therapy in the Treatment of Migraine Headache: A Prospective Randomized Study

Conditions
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Migraine Headache

Intervention / Treatment
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* Other: intradermal injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older age, and (2) Admission to Emergency Department (ED) with headache related to the migraine without aura. Exclusion Criteria: Taking analgesic drugs before admission, Having VAS score of lower than 4 on admission, Having diabetes mellitus, Body mass index>30 kg/m2, Pregnancy, Lactation, Having active bleeding or bleeding disorder, Having active or recurrent gastrointestinal hemorrhage or ulcer, or history of these conditions, Having a serious or life-threatening condition (stroke, intracranial hemorrhage, heart attack, cardiac tamponade, pneumothorax, hemothorax, flail chest, etc.).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Compare to sistemic treatment and mesotherapy.<br>This is a prospective parallel randomized controlled trial conducted with patients admitted to our emergency department with migraine pain | Other: intradermal injection<br>* Mesotherapy was performed by an experienced and trained physician using disposable 4 mm and 6 mm long 30 Gauge needles (Meso-relle, Biotekne SRL, Italy)to the pericarotid region, glabella, and the area between the eyes and ears, and to the area of the head where pain occurred (such as frontal, parietal, occipital region) for each patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in headache intensity | Visual Analog Score(points between 0-10. the most severe pain 10 points, no pain 0 points) scores at 30th, 60th and 120th minutes, and 24th hours from the baseline VAS score (at the beginning of the treatment). | 0-24 hours | 
| need to use analgesics within 24 hours after treatment | We defined this as a requirement of any type analgesics for painkilling at any time within 24 hours of treatment, and this was evaluated by patients, subjectively. we will learn by asking by phone. | 0-24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mesotherapy, Migraine