Mesotherapy Versus Systemic Therapyin Treatment of Migraine Headache

NCT ID: NCT04519346

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2020-05-01

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.

Conditions

Migraine Headache

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Compare to sistemic treatment and mesotherapy.

This is a prospective parallel randomized controlled trial conducted with patients admitted to our emergency department with migraine pain

Group Type: OTHER

intradermal injection

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Abdullah Osman KOCAK

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ataturk University

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Akbas I, Kocak MB, Kocak AO, Gur STA, Dogruyol S, Demir M, Cakir Z. Intradermal mesotherapy versus intravenous dexketoprofen for the treatment of migraine headache without aura: a randomized controlled trial. Ann Saudi Med. 2021 May-Jun;41(3):127-134. doi: 10.5144/0256-4947.2021.127. Epub 2021 Jun 1.

Reference Type: DERIVED

PMID: 34085549 (View on PubMed)

Other Identifiers

AtaturkU0002

Identifier Type: -

Identifier Source: org_study_id