MigraineNCT02580968
Study of Key Electro-acupuncture Technique on Migraine
A study testing electro-acupuncture and flunarizine hydrochloride in people with Migraine, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
A random controlled trail to evaluate the efficacy of migraine standard electroacupuncture formula, and to analysis the regulation of the intensity-effects and to observe the peripheral NO, CGRP and NF-кB expression level of migraine patients after electroacupuncture treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- electro-acupuncture and flunarizine hydrochloride
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Dec 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- met the diagnostic criteria for migraine; suffering from migraine attacks; migraine attacks for more than 5 days per month, and lasts for 3 months; voluntarily join this study with informed consents.
Who cannot join
- other systemic, neurological and psychiatric disorders; headache caused by other diseases; not treatment compliance during the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Longhua Hospital,Shanghai University of Traditional Chinese Medicine
Shanghai, 200032
About this study
A random controlled trail to evaluate the efficacy of migraine standard electroacupuncture formula, and to analysis the regulation of the intensity-effects and to observe the peripheral NO, CGRP and NF-кB expression level of migraine patients after electroacupuncture treatment.
Read the detailed description
acupuncture group(group A): treated by acupuncture for 20 days, 1 time per day control group(group B): treated by FlunarizineHydrochloride for 20 days, 1 table per day.
- Conditions
- Migraine
- Being tested
- electro-acupuncture, flunarizine hydrochloride
- Keywords
- Electroacupuncture therapy, Migraine, Acupuncture Therapy
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electro-acupunctureDevice
electro-acupuncture on acupoints according to the traditional syndrome diagnosis.once per day, for 20 days.
flunarizine hydrochlorideDrug
Also called flunarizine
flunarizine hydrochloride ，10mg/day，for 20 days。
| Study group | Role | What they receive |
|---|---|---|
| electro-acupuncture | Experimental | 100hz, 2min. electro-acupoint: LI4(Large Intestine4) with LV3(Liver3).5times a week. lasting for 4 weeks. Receives: Device: electro-acupuncture |
| routin medicine | Active comparator | one tablet of flunarizine hydrochloride tablet per day. lasting for 20days Receives: Drug: flunarizine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine Disability Assessment Questionnaire (MIDAS)
a scientifically reliable and valid measure of migraine disability that can improve communication between patients and physicians, assess migraine severity and act as an outcome measure to monitor treatment efficacy
Measured: 20 days
Secondary outcomes (5)
The medical outcomes study 36-item short-form health survey(SF-36)
A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study
Measured: 20 days
peripheral Nitrogen Monoxide(NO) protein expression
marker
Measured: 20 days
peripheral Calcitonin gene related peptide(CGRP) protein expression
marker
Measured: 20 days
peripheral Nuclear factor-kappa B(NF-кB) protein expression
marker
Measured: 20 days
Visual Analogue Scale (VAS) to assess pain
Visual Analogue Scale (VAS) were applied to measure pain in patients
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Pei, Ph.D, Study director, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580968
- Sponsor's protocol ID
- 643857003534
- Status last verified
- Feb 2020
- First submitted
- 30 Jul 2015
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Key Electro-acupuncture Technique on Migraine
- ClinicalTrials.gov ID
- NCT02580968
- Acronym / sponsor ID
- 643857003534
- Conditions
- Migraine
- Keywords
- Electroacupuncture therapy, Migraine, Acupuncture Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 Oct 2015 (estimated)
- 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.
A random controlled trail to evaluate the efficacy of migraine standard electroacupuncture formula, and to analysis the regulation of the intensity-effects and to observe the peripheral NO, CGRP and NF-кB expression level of migraine patients after electroacupuncture treatment.
Detailed description
acupuncture group(group A): treated by acupuncture for 20 days, 1 time per day control group(group B): treated by FlunarizineHydrochloride for 20 days, 1 table per day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electro-acupuncture | Experimental | Device: electro-acupuncture100hz, 2min. electro-acupoint: LI4(Large Intestine4) with LV3(Liver3).5times a week. lasting for 4 weeks. |
| routin medicine | Active comparator | Drug: flunarizine hydrochlorideone tablet of flunarizine hydrochloride tablet per day. lasting for 20days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- met the diagnostic criteria for migraine; suffering from migraine attacks; migraine attacks for more than 5 days per month, and lasts for 3 months; voluntarily join this study with informed consents.
Key exclusion criteria (1 listed)
- other systemic, neurological and psychiatric disorders; headache caused by other diseases; not treatment compliance during the study.
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 |
|---|---|---|
| electro-acupunctureelectro-acupuncture on acupoints according to the traditional syndrome diagnosis.once per day, for 20 days. | Device | electro-acupuncture |
| flunarizine hydrochlorideAlso: flunarizineflunarizine hydrochloride ，10mg/day，for 20 days。 | Drug | routin medicine |
Primary outcome
Migraine Disability Assessment Questionnaire (MIDAS)
Time frame: 20 days
a scientifically reliable and valid measure of migraine disability that can improve communication between patients and physicians, assess migraine severity and act as an outcome measure to monitor treatment efficacy
5 secondary outcomes
The medical outcomes study 36-item short-form health survey(SF-36)
Time frame: 20 days
peripheral Nitrogen Monoxide(NO) protein expression
Time frame: 20 days
peripheral Calcitonin gene related peptide(CGRP) protein expression
Time frame: 20 days
peripheral Nuclear factor-kappa B(NF-кB) protein expression
Time frame: 20 days
Visual Analogue Scale (VAS) to assess pain
Time frame: 20 days
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 5 Feb 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.
Jian Pei, Ph.D study director
Longhua Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electro-acupuncture and flunarizine hydrochloride in people with Migraine, run by Shanghai University of Traditional 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 1 inclusion and 1 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 5 Feb 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?
Migraine Disability Assessment Questionnaire (MIDAS) (time frame: 20 days). 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 5 Feb 2020.