Migraine Without AuraNCT04542811
Acupuncture In Migraine Without Aura Patients
A study testing Acupuncture in people with Migraine Without Aura and Acupuncture, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to investigate the effect of acupuncture treatment on attack frequency, pain intensity, and disability in migraine without aura patients who receive prophylaxis treatment. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Migraine Without Aura, Acupuncture
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 30 Sep 2018
- 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 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being diagnosed with migraine according to IHS (International Headache Association)
- Receiving migraine prophylaxis treatment
- Having more than four attacks per month/more than one attack per week
- Not having received acupuncture treatment before.
Who cannot join
- Being diagnosed with migraine with aura/secondary headache
- Having received acupuncture treatment for any reason within the last year
- Not giving consent for acupuncture treatment
- Having a fear of needles.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture For Preventing Of Attack Frequency And Improving Disability In Migraine Without Aura Patients
The investigators aimed to investigate the effect of acupuncture treatment on attack frequency, pain intensity, and disability in migraine without aura patients who receive prophylaxis treatment.
Read the detailed description
Acupuncture is a Traditional Chinese Medicine method that has been used for 3000 years to control symptoms, treat illnesses, and relieve pain. Acupuncture is widely used in many countries today as a complementary therapy, especially in cases of chronic pain. Migraine is one of the diseases in which acupuncture treatment is commonly used. Studies conducted so far have focused more on the effect of acupuncture on pain intensity in patients with migraine. Data comparing the impact of acupuncture on both the attack frequency and disability in migraine are relatively scarce.
- Conditions
- Migraine Without Aura, Acupuncture
- Being tested
- Acupuncture
- Keywords
- migraine, acupuncture, MIDAS
- Medical subject headings
- Migraine without Aura, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture is a complementary therapy modality which is used by needle inserted the specific points on the body.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group will take 12 sessions of acupuncture addition to their prophylaxis treatment. Acupuncture points will be bilateral LI-4, LI-11, ST-8, ST-44, SP-6, GB-1, GB-14, GB-20, LR-3, and GV-14, GV-20. Sterile and single-use stainless steel acupuncture needles measuring 0.25x25 mm will be inserted to a depth of 10 mm and be retained for 30 minute without any further stimulation. Acupuncture will be performed by an acupuncturist with an acupuncture practitioner licence from the Turkish Ministry of Health. Adverse events will be monitored for all acupuncture sessions. Receives: Other: Acupuncture |
| Control Group | No intervention | Control group will take only their migraine prophylaxis treatment. Participants will followed-up 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly attack frequency
The participants will document the each migraine attack days in a month by pain free intervals of at least 48 hours.
Measured: 3 months
Duration of attacks
Duration of the each migraine attack as hour
Measured: 3 months
Pain severity
Pain severity during migraine attacks will be measured via visual analog scale (VAS). While 0 indicates no pain, 10 indicates the most severe pain imaginable.
Measured: 3 months
Secondary outcomes (1)
Disability
Disability will measured via a questionnaire which is an ordinary rating scale to assess the migraine related disability of a patient with migraine. Migraine Disability Assessment (MIDAS) will be used. Migraine Disability Assessment (MIDAS) questionnaire is an ordinary rating scale to assess the migraine related disability of a patient with migraine. It is based on responses to five questions about disability associated with headache in the last three months. MIDAS questionnaire has four point grading system. Scores ranging from 0 to 5 indicates Grade 1 (little or none disability), scores ranging from 6 to 10 indicates Grade 2 (mild disability), scores ranging from 11 to 20 indicates Grade 3 (moderate disability), and scores 21 or greater indicates Grade 4 (severe disability).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Mar 2018
- Primary completion31 Aug 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine Without AuraStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Cayir, Ataturk University
- Investigators
- Yasemin Çayır, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542811
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/113
- Status last verified
- Sep 2020
- First submitted
- 2 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture For Preventing Of Attack Frequency And Improving Disability In Migraine Without Aura Patients
- ClinicalTrials.gov ID
- NCT04542811
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/113
- Conditions
- Migraine Without Aura, Acupuncture
- Keywords
- migraine, acupuncture, MIDAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 9 Sep 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.
The investigators aimed to investigate the effect of acupuncture treatment on attack frequency, pain intensity, and disability in migraine without aura patients who receive prophylaxis treatment.
Detailed description
Acupuncture is a Traditional Chinese Medicine method that has been used for 3000 years to control symptoms, treat illnesses, and relieve pain. Acupuncture is widely used in many countries today as a complementary therapy, especially in cases of chronic pain. Migraine is one of the diseases in which acupuncture treatment is commonly used. Studies conducted so far have focused more on the effect of acupuncture on pain intensity in patients with migraine. Data comparing the impact of acupuncture on both the attack frequency and disability in migraine are relatively scarce.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: AcupunctureIntervention group will take 12 sessions of acupuncture addition to their prophylaxis treatment. Acupuncture points will be bilateral LI-4, LI-11, ST-8, ST-44, SP-6, GB-1, GB-14, GB-20, LR-3, and GV-14, GV-20. Sterile and single-use stainless steel acupuncture needles measuring 0.25x25 mm will be inserted to a depth of 10 mm and be retained for 30 minute without any further stimulation. Acupuncture will be performed by an acupuncturist with an acupuncture practitioner licence from the Turkish Ministry of Health. Adverse events will be monitored for all acupuncture sessions. |
| Control Group | No intervention | –Control group will take only their migraine prophylaxis treatment. Participants will followed-up 3 months. |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Being diagnosed with migraine according to IHS (International Headache Association)
- Receiving migraine prophylaxis treatment
- Having more than four attacks per month/more than one attack per week
- Not having received acupuncture treatment before.
Key exclusion criteria (4 listed)
- Being diagnosed with migraine with aura/secondary headache
- Having received acupuncture treatment for any reason within the last year
- Not giving consent for acupuncture treatment
- Having a fear of needles.
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 |
|---|---|---|
| AcupunctureAcupuncture is a complementary therapy modality which is used by needle inserted the specific points on the body. | Other | Intervention group |
Primary outcome
Monthly attack frequency
Time frame: 3 months
The participants will document the each migraine attack days in a month by pain free intervals of at least 48 hours.
Duration of attacks
Time frame: 3 months
Duration of the each migraine attack as hour
Pain severity
Time frame: 3 months
Pain severity during migraine attacks will be measured via visual analog scale (VAS). While 0 indicates no pain, 10 indicates the most severe pain imaginable.
1 secondary outcome
Disability
Time frame: 3 months
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 16 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Yasemin Çayır study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Migraine Without Aura and Acupuncture, 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 4 inclusion and 4 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 16 Sep 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?
Monthly attack frequency (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2020.