Mesotherapy Versus Systemic Therapyin Treatment of Migraine Headache

NCT04519346 | Completed

• 1 other identifier: AtaturkU0002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Mesotherapy; Migraine

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Compare to sistemic treatment and mesotherapy.

OTHER

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

Other: intradermal injection

Interventions

intradermal injection 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

Compare to sistemic treatment and mesotherapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older age, and (2)
• Admission to Emergency Department (ED) with headache related to the migraine without aura.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34085549 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Injections, Intradermal

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 19, 2020
• Study Start: December 1, 2019
• Primary Completion: February 29, 2020
• Study Completion: May 1, 2020
• Last Updated: August 19, 2020

Record last verified: 2020-08

Locations

TU (1)