Mesotherapy Versus Systemic Therapyin Treatment of Migraine Headache

Migraine Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04519346
• Other study ID #: AtaturkU0002
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: August 2020
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 1, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Other:
• intradermal injection
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

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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