Mesotherapy Versus Systemic Therapyin Treatment of Migraine Headache

Not Applicable

Completed

• Conditions: Migraine Headache
• Interventions: Other: intradermal injection

• Registration Number: NCT04519346
• Lead Sponsor: Ataturk University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-01
• Primary Completion: 2020-02-29
• Study Completion: 2020-05-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-18
• Last Update Submitted: 2020-08-18
• Study First Posted: 2020-08-19
• Last Update Posted: 2020-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Compare to sistemic treatment and mesotherapy.	intradermal injection	This is a prospective parallel randomized controlled trial conducted with patients admitted to our emergency department with migraine pain

Primary Outcome Measures

Name	Time	Method
change in headache intensity	0-24 hours	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).
need to use analgesics within 24 hours after treatment	0-24 hours	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.

Trial Locations

Locations (1)

Ataturk University; 🇹🇷 Erzurum, Turkey