Migraine HeadacheNCT04519346
Mesotherapy Versus Systemic Therapyin Treatment of Migraine Headache
A study testing intradermal injection in people with Migraine Headache, run by Ataturk University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Headache
- What is being tested?
- intradermal injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older age, and (2)
- Admission to Emergency Department (ED) with headache related to the migraine without aura.
Who cannot join
- 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,
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- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intradermal Mesotherapy With Systemic Therapy in the Treatment of Migraine Headache: A Prospective Randomized Study
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
- Being tested
- intradermal injection
- Keywords
- Mesotherapy, Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intradermal injectionOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: intradermal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Dec 2019
- Primary completion29 Feb 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Osman KOCAK, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519346
- Sponsor's protocol ID
- AtaturkU0002
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34085549
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intradermal Mesotherapy With Systemic Therapy in the Treatment of Migraine Headache: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04519346
- Acronym / sponsor ID
- AtaturkU0002
- Conditions
- Migraine Headache
- Keywords
- Mesotherapy, Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compare to sistemic treatment and mesotherapy. | Other | Other: intradermal injectionThis is a prospective parallel randomized controlled trial conducted with patients admitted to our emergency department with migraine pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years and older age, and (2)
- Admission to Emergency Department (ED) with headache related to the migraine without aura.
Key exclusion criteria (9 listed)
- Taking analgesic drugs before admission,
- Having VAS score of lower than 4 on admission,
- Having diabetes mellitus,
- Body mass index>30 kg/m2,
- Pregnancy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intradermal injectionMesotherapy 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 | Other | Compare to sistemic treatment and mesotherapy. |
Primary outcome
change in headache intensity
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Derived from this study: PubMed 34085549Akbas 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intradermal injection in people with Migraine Headache, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in headache intensity (time frame: 0-24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04519346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.