Migraine Without AuraNCT04636359
Study the Effect of Acupuncture on Migraine Patient Without Aura Via Functional Magnetic Resonance Imaging.
A study testing Acupuncture stimulation in people with Migraine Without Aura, run by Beijing University of Chinese Medicine at 1 site in China.
Trial summary
This study recruits 30 subjects into three groups, including two experimental groups and one control group. The two experimental groups receive acupuncture treatment for 4 weeks and two times functional magnetic resonance imaging scans as well as clinical symptom assessments. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Without Aura
- What is being tested?
- Acupuncture stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2017to 1 Feb 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fitting to the standard of migraine without aura in the international classification of headache disease (ICHD-2) issued by the international headache society in 2004.
- Age from 18 to 55, male or female, with right-handedness.
- Having no depression or other serious mental illness.
- Having no psychoactive drugs taken in the past 3 months, or vasoactive drugs in the past 2 weeks.
- Having no habit of taking analgesics from a long time.
Who cannot join
- Having the first headache attack of migraine after 55 years old.
- Having a history of head injury, cluster headache, or other unclassified headaches.
- Taking medicine to prevent migraine in recent 4 weeks.
- Having the serious asymmetry or definite pathological changes in the anatomical structure of the head through the MRI scan.
- Cannot hold on the times of the MRI scan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
This study recruits 30 subjects into three groups, including two experimental groups and one control group. The two experimental groups receive acupuncture treatment for 4 weeks and two times functional magnetic resonance imaging scans as well as clinical symptom assessments. The control group receive one scan without any intervention. The aim of this study is to find the whether the effect of acupuncture treatment have diversity among migraineurs with different disease course.
Read the detailed description
This study recruits 10 patients with long course (> 5 years) without aura migraine, 10 patients with short course (< 5 years) without aura migraine and 10 healthy volunteers who meet the inclusion and exclusion criteria. Among the study, two migraine patient groups receive acupuncture treatment for 4 weeks, the frequency is 30 minutes each time, three times a week. According to the national standard of the people's Republic of China (GB / T 12346-2006) acupoint name and location, the acupuncture treatment includes SJ23 (Si Zhu Kong, unilateral), GB8 (Shuai Gu, unilateral), EX-HN5 (Tai Yang, unilateral), GB20 (Feng Chi, unilateral), LI4 (He Gu, bilateral), GB41 (Zu Lin Qi, bilateral), GB34 (Yang Ling Quan, bilateral) and SJ5 (Wai Guan, bilateral) acupoints. Both migraine patients receive scan in functional magnetic resonance imaging (Siemens 3.0T superconducting magnetic resonance scanner, Germany) and symptom scale assessment before the first acupuncture stimulation and post the last acupuncture stimulation. Healthy volunteers receive only one scanning without intervention.
- Conditions
- Migraine Without Aura
- Being tested
- Acupuncture stimulation
- Keywords
- Acupuncture, Functional magnetic resonance imaging
- Medical subject headings
- Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture stimulationBehavioural
The intervention is about acupuncture treatment, which has 4 weeks acupoint stimulation and the frequency is 30 minutes each times for 3 times per week. The acupoints include SJ23 (Si Zhu Kong, unilateral), GB8 (Shuai Gu, unilateral), EX-HN5 (Tai Yang, unilateral), GB20 (Feng Chi, unilateral), LI4 (He Gu, bilateral), GB41 (Zu Lin Qi, bilateral), GB34 (Yang Ling Quan, bilateral) and SJ5 (Wai Guan, bilateral).
| Study group | Role | What they receive |
|---|---|---|
| Long term course of migraine patient without aura | Experimental | Patients in this group have the history of migraine without aura more than 5 years. Receives: Behavioral: Acupuncture stimulation |
| Short term course of migraine patient without aura | Experimental | Patients in this group have the history of migraine without aura equal or less than 5 years. Receives: Behavioral: Acupuncture stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Intensity
The headache intensity is measured by the value of Visual Analogue Scale which limits 1 to 10. The higher value of this scale represents the worse headache.
Measured: Change from Visual Analogue Scale at 1 months.
Headache Days
The days when headache attacked. The increased day represents the worse headache.
Measured: Change from the number of day at 1 months.
Headache Frequency
The maximum times in one day during the headache attacked. The increased time represents the worse headache.
Measured: Change from the times of headache attack at 1 months.
Dataset of functional magnetic resonance imaging on brain
Dataset of functional magnetic resonance imaging on brain includes functional images, structural images and diffusion tensor images.
Measured: Changes from the dataset of subject's brain area at 1 months.
Secondary outcomes (2)
Pittsburgh Sleep Quality Index
One of the clinical measurement. The higher value represents the worse quality of sleep.
Measured: Change from the value of Pittsburgh Sleep Quality Index at 1 months.
Medical Outcomes Study Short-Form 36 questionnaire
One of the clinical measurement. The value range is 0 to 10, the higher value represents the better quality of life.
Measured: Change from the value of Medical Outcomes Study Short-Form 36 questionnaire at 1 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start30 Oct 2017
- Primary completion30 Dec 2019
- Study completion1 Feb 2020
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.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two experimental groups with different condition receive identical intervention, with control group as baseline for comparison.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Ren, Beijing University of Chinese Medicine
- Investigators
- Yi Ren, Doctor, Principal investigator, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636359
- Sponsor's protocol ID
- BeijingUCM-KWu
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data of this study includes two aspect, data of brain scans and data of clinical symptom scales. The latter data will be shared to other researchers who contact us via email. The former data, however, is a DICOM format data that hard to analysis in non specialists. Besides, the size of DICOM data is much big that we haven't enough funding to support it in website. Thus, we haven't decided to share this kind of dataset. Except for those data, other data within our study is willing to be share. Our email: clancy\_wu@bucm.edu.cn; clancy\_wu@126.com; clancy.wu94@gmail.com.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
- ClinicalTrials.gov ID
- NCT04636359
- Acronym / sponsor ID
- BeijingUCM-KWu
- Conditions
- Migraine Without Aura
- Keywords
- Acupuncture, Functional magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 19 Nov 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.
This study recruits 30 subjects into three groups, including two experimental groups and one control group. The two experimental groups receive acupuncture treatment for 4 weeks and two times functional magnetic resonance imaging scans as well as clinical symptom assessments. The control group receive one scan without any intervention. The aim of this study is to find the whether the effect of acupuncture treatment have diversity among migraineurs with different disease course.
Detailed description
This study recruits 10 patients with long course (> 5 years) without aura migraine, 10 patients with short course (< 5 years) without aura migraine and 10 healthy volunteers who meet the inclusion and exclusion criteria. Among the study, two migraine patient groups receive acupuncture treatment for 4 weeks, the frequency is 30 minutes each time, three times a week. According to the national standard of the people's Republic of China (GB / T 12346-2006) acupoint name and location, the acupuncture treatment includes SJ23 (Si Zhu Kong, unilateral), GB8 (Shuai Gu, unilateral), EX-HN5 (Tai Yang, unilateral), GB20 (Feng Chi, unilateral), LI4 (He Gu, bilateral), GB41 (Zu Lin Qi, bilateral), GB34 (Yang Ling Quan, bilateral) and SJ5 (Wai Guan, bilateral) acupoints. Both migraine patients receive scan in functional magnetic resonance imaging (Siemens 3.0T superconducting magnetic resonance scanner, Germany) and symptom scale assessment before the first acupuncture stimulation and post the last acupuncture stimulation. Healthy volunteers receive only one scanning without intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two experimental groups with different condition receive identical intervention, with control group as baseline for comparison.
| Arm | Type | Receives |
|---|---|---|
| Long term course of migraine patient without aura | Experimental | Behavioral: Acupuncture stimulationPatients in this group have the history of migraine without aura more than 5 years. |
| Short term course of migraine patient without aura | Experimental | Behavioral: Acupuncture stimulationPatients in this group have the history of migraine without aura equal or less than 5 years. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Fitting to the standard of migraine without aura in the international classification of headache disease (ICHD-2) issued by the international headache society in 2004.
- Age from 18 to 55, male or female, with right-handedness.
- Having no depression or other serious mental illness.
- Having no psychoactive drugs taken in the past 3 months, or vasoactive drugs in the past 2 weeks.
- Having no habit of taking analgesics from a long time.
Key exclusion criteria (5 listed)
- Having the first headache attack of migraine after 55 years old.
- Having a history of head injury, cluster headache, or other unclassified headaches.
- Taking medicine to prevent migraine in recent 4 weeks.
- Having the serious asymmetry or definite pathological changes in the anatomical structure of the head through the MRI scan.
- Cannot hold on the times of the MRI scan.
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 |
|---|---|---|
| Acupuncture stimulationThe intervention is about acupuncture treatment, which has 4 weeks acupoint stimulation and the frequency is 30 minutes each times for 3 times per week. The acupoints include SJ23 (Si Zhu Kong, unilateral), GB8 (Shuai Gu, unilateral), EX-HN5 (Tai Yang, unilateral), GB20 (Feng Chi, unilateral), LI4 (He Gu, bilateral), GB41 (Zu Lin Qi, bilateral), GB34 (Yang Ling Quan, bilateral) and SJ5 (Wai Guan, bilateral). | Behavioural | Long term course of migraine patient without aura, Short term course of migraine patient without aura |
Primary outcome
Headache Intensity
Time frame: Change from Visual Analogue Scale at 1 months.
The headache intensity is measured by the value of Visual Analogue Scale which limits 1 to 10. The higher value of this scale represents the worse headache.
Headache Days
Time frame: Change from the number of day at 1 months.
The days when headache attacked. The increased day represents the worse headache.
Headache Frequency
Time frame: Change from the times of headache attack at 1 months.
The maximum times in one day during the headache attacked. The increased time represents the worse headache.
Dataset of functional magnetic resonance imaging on brain
Time frame: Changes from the dataset of subject's brain area at 1 months.
Dataset of functional magnetic resonance imaging on brain includes functional images, structural images and diffusion tensor images.
2 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: Change from the value of Pittsburgh Sleep Quality Index at 1 months.
Medical Outcomes Study Short-Form 36 questionnaire
Time frame: Change from the value of Medical Outcomes Study Short-Form 36 questionnaire at 1 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 20 Nov 2020.
- Individual participant dataSharing planned: No. The data of this study includes two aspect, data of brain scans and data of clinical symptom scales. The latter data will be shared to other researchers who contact us via email. The former data, however, is a DICOM format data that hard to analysis in non specialists. Besides, the size of DICOM data is much big that we haven't enough funding to support it in website. Thus, we haven't decided to share this kind of dataset. Except for those data, other data within our study is willing to be share. Our email: clancy_wu@bucm.edu.cn; clancy_wu@126.com; clancy.wu94@gmail.com.
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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.
Yi Ren, Doctor principal investigator
Dongzhimen Hospital, Beijing
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 stimulation in people with Migraine Without Aura, run by Beijing University of Chinese Medicine at 1 site in China.
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 5 inclusion and 5 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 20 Nov 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 China. 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?
Headache Intensity (time frame: Change from Visual Analogue Scale at 1 months.). The study lists 4 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 20 Nov 2020.