Mesotherapy Versus Systemic Therapyin Treatment of Migraine Headache
Primary Purpose
Migraine Headache
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
intradermal injection
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Headache focused on measuring Mesotherapy, Migraine
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.).
Sites / Locations
- Ataturk University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Compare to sistemic treatment and mesotherapy.
Arm Description
This is a prospective parallel randomized controlled trial conducted with patients admitted to our emergency department with migraine pain
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04519346
Brief Title
Mesotherapy Versus Systemic Therapyin Treatment of Migraine Headache
Official Title
Comparison of Intradermal Mesotherapy With Systemic Therapy in the Treatment of Migraine Headache: A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
Keywords
Mesotherapy, Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Compare to sistemic treatment and mesotherapy.
Arm Type
Other
Arm Description
This is a prospective parallel randomized controlled trial conducted with patients admitted to our emergency department with migraine pain
Intervention Type
Other
Intervention Name(s)
intradermal injection
Intervention Description
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
Primary Outcome Measure Information:
Title
change in headache intensity
Description
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).
Time Frame
0-24 hours
Title
need to use analgesics within 24 hours after treatment
Description
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.
Time Frame
0-24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.).
Facility Information:
Facility Name
Ataturk University
City
Erzurum
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34085549
Citation
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.
Results Reference
derived
Learn more about this trial
Mesotherapy Versus Systemic Therapyin Treatment of Migraine Headache
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