Migraine, DysmenorrheaNCT06676670

Discussion on the Mechanism of Acupuncture on Patients with Paroxysmal Migraine Without Aura : a Randomized Controlled Clinical Trial

A study testing real acupuncture in people with Migraine, Dysmenorrhea, run by Bo Huang at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

Background: Migraine is common but poorly managed with drugs. Acupuncture, a non-pharmacological approach, has shown promise, yet its mechanisms remain unclear. This study aims to assess the efficacy and specificity of acupuncture for acute paroxysmal migraine without aura. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Migraine, Dysmenorrhea
What is being tested?: real acupuncture
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 108 participants
Where: 1 siteChina
Study dates: 19 Feb 2024to 31 May 2026
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1\They met the diagnostic criteria of migraine without aura and had a history ofmore than 1 year; 2\Age 18-65 years old;
18.5kg/m2 ≤ BMI ≤ 30.0kg / m2,right-handed; ④ The average frequency of migraine attacks in recent 6 months was ≥ 2-8 times per month; The average number of migraine attacks per month in recent 6 months was less than 15 days; The neurological examination was negative, and the CT or MRI of the head was normal; There was no experience of acupuncture or migraine prevention and treatment in recent 3 months; Able to complete the baseline migraine diary; Agree to sign the informed consent form.

Who cannot join

Other types of primary headache or secondary headache; It is complicated with serious primary diseases such as cardiovascular,cerebrovascular, liver, kidney, gastrointestinal, blood, nervous system, etc; Complicated with severe mental illness; In the past 12 weeks, migraine drugs were taken orally or headache treatment methods such as acupuncture and physiotherapy were received; Lactation, pregnant women and planned pregnant women; Participate in another clinical trial at the same time; Illiterate, unable to read comprehension scale; Poor compliance.

Trial locations and contacts

1 site in 1 country.

China1 site

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan

Other trials in China

About this study

Official title: Huazhong University of Science and Technology

Methods: A randomized, single-blind, sham-controlled trial will recruit 60 patients from Tongji Hospital, China. Patients will receive 20 sessions of Deqi or sham acupuncture over 4 weeks and be followed for 8 weeks. Treatments will occur twice within 4 hours of headache onset. Primary outcome is complete headache remission within 120 minutes after two treatments without analgesics. Secondary outcomes include headache intensity reduction, remission rates, and adverse events. Blind assessment will be conducted after at least one session. Data will be analyzed using full and per-protocol sets.

Ethics: Approved by the Clinical Trial Ethics Committee (approval no: TJ-IRB20220573). Written consent will be obtained. Results will be published in a peer-reviewed journal.

Conditions: Migraine, Dysmenorrhea
Being tested: real acupuncture, sham acupuncture
Medical subject headings: Migraine Disorders, Dysmenorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

real acupunctureOther
Real Acupuncture Group Main acupoints: Hegu (bilateral), Taichong (bilateral), Taiyang (unilateral), shuogu (unilateral), Fengchi (unilateral); Positioning: refer to the 2006 national standard of the people's Republic of China (gb/t 12346-2006) acupoint names and positioning Operation method: supine position, skin routine disinfection. The special model of acupuncture and moxibustion (0.30mm × 30mm), fix the gasket on the acupoint skin with seam free tape, and then acupuncture. After acupuncture, each acupoint will be lifted, inserted and twisted three times in small amplitude; The needle will be kept for 30 minutes. During this period, the technique of small amplitude uniform lifting, inserting and twisting (3 times) will be performed every 10 minutes. A total of four times of needling will be performed.
sham acupunctureOther
Sham acupuncture group Acupoint selection: select eight stimulation points at the neck and shoulder. Stimulation point 1: the midpoint of the line between the shoulder well and the giant bone (both sides); Stimulation point 2: 5 inches (both sides) of the inferior paraspinal process of the seventh thoracic vertebra; Stimulus point 3: the inferior paraspinal process of the eighth thoracic vertebra will be opened 5 inches (bilateral); Stimulus point 4: 5 inches (both sides) of the infraspinous process of the ninth thoracic vertebra.
Positioning: refer to the 2006 national standard of the people's Republic of China (gb/t 12346-2006) acupoint names and positioning to avoid acupoints.
Operation method: supine position, skin routine disinfection. Streitberger acupuncture (0. 300×30mm). Fix the gasket on the acupoint skin with seam free tape,and then acupuncture. After acupuncture, each acupoint will be lifted, inserted and twisted three times in small amplitude; The needle will be kept fo

Study groups in NCT06676670
Study group	Role	What they receive
real acupuncture group	Experimental	1. The patient immediately received acupuncture treatment and imaging scan on the scanning bed (acupuncture and imaging scan at the same time). Acupuncture left Hegu point to promote qi. Axial T2WI imaging for 48 seconds, fMR-BOLD imaging for 8 minutes and 11 seconds, and ASL imaging for 6 minutes and 03 seconds were simultaneously collected during acupuncture. The scanning time of each sequence was divided into 4 time periods, each time period was 1 time, each scanning sequence was 4 times, each time was 10 seconds, and the duration of acupuncture was 15 minutes and 02 seconds. 2. After acupuncture withdrawal, axial T2WI imaging was repeated for 48 seconds, fMRI-Bold imaging for 8 minutes and 11 seconds, and ASL imaging for 6 minutes and 03 seconds. Receives: Other: real acupuncture
sham acupuncture group	Sham comparator	Control group (false acupuncture group) 1. Axial imaging of DWI was performed before the patient underwent pseudoacupuncture (12 minutes 08 seconds). 2. The patient immediately underwent a sham acupuncture and imaging scan on the scanning bed (the sham acupuncture and imaging scan were performed simultaneously). Pseudoacupuncture left Hegu point. DWI axial imaging (12 minutes 08 seconds) was collected synchronously during the fake acupuncture. The scanning time during the fake acupuncture was divided into 4 time periods, with 1 needle in each time period, 4 needles in each time period, each time for 10 seconds, and the duration of the fake acupuncture was 12 minutes 08 seconds. 3. Axial DWI imaging was repeated (12 minutes and 08 seconds) after acupuncture withdrawal. Receives: Other: sham acupuncture
healthy controls	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of people with complete remission of migraine
Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Feb 202431 May 2026

First posted6 Nov 2024
Study start19 Feb 2024
Primary completion19 Feb 2026 (estimated)
Study completion31 May 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Migraine, DysmenorrheaStudies 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: Participant
Enrolment: 108 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06676670
Sponsor's protocol ID: 2021MWOATJ01
Status last verified: Feb 2024
First submitted: 5 Nov 2024
Last updated: 8 Nov 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Huazhong University of Science and Technology
ClinicalTrials.gov ID: NCT06676670
Acronym / sponsor ID: 2021MWOATJ01
Conditions: Migraine, Dysmenorrhea
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 108 participants (estimated)
Lead sponsor: Bo HuangUniversity, hospital or other
Study start: 19 Feb 2024 (actual)
Primary completion: 19 Feb 2026 (estimated)
Study completion: 31 May 2026 (estimated)
First posted: 6 Nov 2024 (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.

Ethics: Approved by the Clinical Trial Ethics Committee (approval no: TJ-IRB20220573). Written consent will be obtained. Results will be published in a peer-reviewed journal.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
real acupuncture group	Experimental	Other: real acupuncture1. The patient immediately received acupuncture treatment and imaging scan on the scanning bed (acupuncture and imaging scan at the same time). Acupuncture left Hegu point to promote qi. Axial T2WI imaging for 48 seconds, fMR-BOLD imaging for 8 minutes and 11 seconds, and ASL imaging for 6 minutes and 03 seconds were simultaneously collected during acupuncture. The scanning time of each sequence was divided into 4 time periods, each time period was 1 time, each scanning sequence was 4 times, each time was 10 seconds, and the duration of acupuncture was 15 minutes and 02 seconds. 2. After acupuncture withdrawal, axial T2WI imaging was repeated for 48 seconds, fMRI-Bold imaging for 8 minutes and 11 seconds, and ASL imaging for 6 minutes and 03 seconds.
sham acupuncture group	Sham comparator	Other: sham acupunctureControl group (false acupuncture group) 1. Axial imaging of DWI was performed before the patient underwent pseudoacupuncture (12 minutes 08 seconds). 2. The patient immediately underwent a sham acupuncture and imaging scan on the scanning bed (the sham acupuncture and imaging scan were performed simultaneously). Pseudoacupuncture left Hegu point. DWI axial imaging (12 minutes 08 seconds) was collected synchronously during the fake acupuncture. The scanning time during the fake acupuncture was divided into 4 time periods, with 1 needle in each time period, 4 needles in each time period, each time for 10 seconds, and the duration of the fake acupuncture was 12 minutes 08 seconds. 3. Axial DWI imaging was repeated (12 minutes and 08 seconds) after acupuncture withdrawal.
healthy controls	No intervention	–

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

1\They met the diagnostic criteria of migraine without aura and had a history ofmore than 1 year; 2\Age 18-65 years old;

Key exclusion criteria (1 listed)

Other types of primary headache or secondary headache; It is complicated with serious primary diseases such as cardiovascular,cerebrovascular, liver, kidney, gastrointestinal, blood, nervous system, etc; Complicated with severe mental illness; In the past 12 weeks, migraine drugs were taken orally or headache treatment methods such as acupuncture and physiotherapy were received; Lactation, pregnant women and planned pregnant women; Participate in another clinical trial at the same time; Illiterate, unable to read comprehension scale; Poor compliance.

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
real acupunctureReal Acupuncture Group Main acupoints: Hegu (bilateral), Taichong (bilateral), Taiyang (unilateral), shuogu (unilateral), Fengchi (unilateral); Positioning: refer to the 2006 national standard of the people's Republic of China (gb/t 12346-2006) acupoint names and positioning Operation method: supine position, skin routine disinfection. The special model of acupuncture and moxibustion (0.30mm × 30mm), fix the gasket on the acupoint skin with seam free tape, and then acupuncture. After acupuncture, each acupoint will be lifted, inserted and twisted three times in small amplitude; The needle will be kept for 30 minutes. During this period, the technique of small amplitude uniform lifting, inserting and twisting (3 times) will be performed every 10 minutes. A total of four times of needling will be performed.	Other	real acupuncture group
sham acupunctureSham acupuncture group Acupoint selection: select eight stimulation points at the neck and shoulder. Stimulation point 1: the midpoint of the line between the shoulder well and the giant bone (both sides); Stimulation point 2: 5 inches (both sides) of the inferior paraspinal process of the seventh thoracic vertebra; Stimulus point 3: the inferior paraspinal process of the eighth thoracic vertebra will be opened 5 inches (bilateral); Stimulus point 4: 5 inches (both sides) of the infraspinous process of the ninth thoracic vertebra. Positioning: refer to the 2006 national standard of the people's Republic of China (gb/t 12346-2006) acupoint names and positioning to avoid acupoints. Operation method: supine position, skin routine disinfection. Streitberger acupuncture (0. 300×30mm). Fix the gasket on the acupoint skin with seam free tape,and then acupuncture. After acupuncture, each acupoint will be lifted, inserted and twisted three times in small amplitude; The needle will be kept fo	Other	sham acupuncture group

Primary outcome

Proportion of people with complete remission of migraine
Time frame: 2 hours

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.

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 real acupuncture in people with Migraine, Dysmenorrhea, run by Bo Huang 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 2 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: status not confirmed, as of the sponsor's last update on 8 Nov 2024. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

Proportion of people with complete remission of migraine (time frame: 2 hours). 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 NCT06676670.

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 8 Nov 2024.