Menstrual MigraineNCT03702114
Detecting Auricular Points in MMG by a Novel APD ( APD-MMG )
An observational study of Menstrual Migraine, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This pilot study is designed to validate the diagnostic ability of a novel APD for auricular point detection among patients with menstrual migraine (MMG), as compared with an already commercialized device. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Migraine
- What is being tested?
- auricular point detection
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Oct 2018to 31 Mar 2019
- Phase
- Observational
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Eligible menstrual migraine patients will be recruited from the Sassoon Road Clinic of the School of Chinese Medicine, the University of Hong Kong.
Who may be able to join
- When attacks, average migraine pain severity >=5 point measured by a 10-point VAS scale;
- Diagnosed pure menstrual migraine without aura or menstrually related migraine without aura according to The International Classification of Headache Disorders: 2nd edition;
- Provide written inform consent;
- Free of any other diagnosed psychological conditions;
Who cannot join
- with any other diseases such as cardiovascular, renal, neurological, digestive, hepatic, respiratory disease
- Pregnancy or lactation
- Participation in a clinical study that may interfere with participation in this study
- History of or current tobacco, alcohol use
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
- Unable to provide written informed consent due to any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detecting Auricular Points Among Patients With Menstrual Migraine by A Novel Auricular Point Detector (APD): A Pilot Diagnostic Accuracy Study
This pilot study is designed to validate the diagnostic ability of a novel APD for auricular point detection among patients with menstrual migraine (MMG), as compared with an already commercialized device.
Read the detailed description
This pilot study is designed to evaluate the diagnostic ability of a novel APD for auricular point detection among patients with menstrual migraine (MMG), as compared with an already commercialized device. The investigators will test if the novel APD could provide a more reliable and quantifiable diagnosis of MMG-related auricular point than traditional devices currently available in the market; The study will also use the APD device to test whether the cutaneous electrical impedance detected from the corresponding auricular points by the novel device is the lowest in the reproductive organ and facial area in the MMG population. As a pilot study, 12 patients with MMG will be recruited from the School of Chinese Medicine, the University of Hong Kong. 12 healthy subjects will be recruited from the university community. Auricular acupoint detection will be accomplished with the new device and a control device. The electrical impedance will be measured and recorded. Patient's condition will also be evaluated by the visual analogue scale (VAS) and the Modified New England Center of Headache (NECH) headache calendar. The specificity and sensitivity of the auricular point detection by the APD device will be calculated. Cohen's kappa coefficient (κ) will be used to test the inter-methods reliability, test-retest reliability, and inter-tester reliability. Moreover, the Pearson Correlation Coefficient will be used to test the correlation between the electrical impedance of the auricular point and the pain intensity score.
- Conditions
- Menstrual Migraine
- Being tested
- auricular point detection
- Keywords
- menstrual migraine, auricular point, diagnostic accuracy, Auricular Point Detection device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auricular point detectionDevice
This device is only for auricular detection. No additional intervention will be delivered.
| Study group | Role | What they receive |
|---|---|---|
| MMG group | Patients in this group will receive auricular point detection which is accomplished by the novel auricular point detector device. There is no addition to the patient's routine care. Receives: Device: auricular point detection | |
| Control group | This group includes healthy subject, for whom no treatment will be performed. Only auricular point detection by the auricular point detector will be conducted. Receives: Device: auricular point detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
cohen's kappa coefficient
The Cohen's kappa coefficient is a statistical test used to validate the inter-method reliability, test-retest reliability and inter-observer reliability of the device.
Measured: baseline
Secondary outcomes (5)
the Visual Analogue Scale (VAS)
The VAS is a common instrument used to measure pain intensity. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates worst pain possible.
Measured: baseline
the Modified New England Center of Headache (NECH) headache calendar
The Modified New England Center of Headache (NECH) headache calendar is a pain diary that can be used to record the time, frequency, intensity and relief of migraine attacks in a month. It employs a 0-10 numeric rating scale (NRS) to quantify the pain intensity of migraine. The frequency and the average pain intensity of menstrual migraine is calculated.
Measured: baseline
self-developed questionnaire on patient's attitude towards complementary therapies for pain management
This is a self-developed questionnaire which includes 10 items aiming to survey patient's attitude towards the use of complementary therapies for pain management. This questionnaire only includes descriptive answers to be choose. The percentage for each choice will calculated.
Measured: baseline
The diagnostic specificity of the device
The specificity test is a test to validate the ability of a diagnosis to tell the 'non-disease' among those without the disease.
Measured: baseline
The diagnostic sensitivity of the device
The sensitivity test is a test to validate the ability of a diagnosis to tell the 'disease' among those with the disease.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start15 Oct 2018 (estimated)
- Primary completion31 Jan 2019 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual MigraineStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, City University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Lixing Lao, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702114
- Sponsor's protocol ID
- SCM-ACU-03
- Status last verified
- Oct 2018
- First submitted
- 8 Oct 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing will be at the discretion of the study-involved participants and the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Auricular Points Among Patients With Menstrual Migraine by A Novel Auricular Point Detector (APD): A Pilot Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT03702114
- Acronym / sponsor ID
- SCM-ACU-03
- Conditions
- Menstrual Migraine
- Keywords
- menstrual migraine, auricular point, diagnostic accuracy, Auricular Point Detection device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, City University of Hong Kong
- Study start
- 15 Oct 2018 (estimated)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 10 Oct 2018 (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 pilot study is designed to validate the diagnostic ability of a novel APD for auricular point detection among patients with menstrual migraine (MMG), as compared with an already commercialized device.
Detailed description
This pilot study is designed to evaluate the diagnostic ability of a novel APD for auricular point detection among patients with menstrual migraine (MMG), as compared with an already commercialized device. The investigators will test if the novel APD could provide a more reliable and quantifiable diagnosis of MMG-related auricular point than traditional devices currently available in the market; The study will also use the APD device to test whether the cutaneous electrical impedance detected from the corresponding auricular points by the novel device is the lowest in the reproductive organ and facial area in the MMG population. As a pilot study, 12 patients with MMG will be recruited from the School of Chinese Medicine, the University of Hong Kong. 12 healthy subjects will be recruited from the university community. Auricular acupoint detection will be accomplished with the new device and a control device. The electrical impedance will be measured and recorded. Patient's condition will also be evaluated by the visual analogue scale (VAS) and the Modified New England Center of Headache (NECH) headache calendar. The specificity and sensitivity of the auricular point detection by the APD device will be calculated. Cohen's kappa coefficient (κ) will be used to test the inter-methods reliability, test-retest reliability, and inter-tester reliability. Moreover, the Pearson Correlation Coefficient will be used to test the correlation between the electrical impedance of the auricular point and the pain intensity score.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMG group | – | Device: auricular point detectionPatients in this group will receive auricular point detection which is accomplished by the novel auricular point detector device. There is no addition to the patient's routine care. |
| Control group | – | Device: auricular point detectionThis group includes healthy subject, for whom no treatment will be performed. Only auricular point detection by the auricular point detector will be conducted. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Eligible menstrual migraine patients will be recruited from the Sassoon Road Clinic of the School of Chinese Medicine, the University of Hong Kong.
Key inclusion criteria (4 listed)
- When attacks, average migraine pain severity >=5 point measured by a 10-point VAS scale;
- Diagnosed pure menstrual migraine without aura or menstrually related migraine without aura according to The International Classification of Headache Disorders: 2nd edition;
- Provide written inform consent;
- Free of any other diagnosed psychological conditions;
Key exclusion criteria (6 listed)
- with any other diseases such as cardiovascular, renal, neurological, digestive, hepatic, respiratory disease
- Pregnancy or lactation
- Participation in a clinical study that may interfere with participation in this study
- History of or current tobacco, alcohol use
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of 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 |
|---|---|---|
| auricular point detectionThis device is only for auricular detection. No additional intervention will be delivered. | Device | Control group, MMG group |
Primary outcome
cohen's kappa coefficient
Time frame: baseline
The Cohen's kappa coefficient is a statistical test used to validate the inter-method reliability, test-retest reliability and inter-observer reliability of the device.
5 secondary outcomes
the Visual Analogue Scale (VAS)
Time frame: baseline
the Modified New England Center of Headache (NECH) headache calendar
Time frame: baseline
self-developed questionnaire on patient's attitude towards complementary therapies for pain management
Time frame: baseline
The diagnostic specificity of the device
Time frame: baseline
The diagnostic sensitivity of the device
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Individual participant dataSharing planned: No. IPD sharing will be at the discretion of the study-involved participants and the principal investigator.
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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.
Lixing Lao principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Migraine, run by The University of Hong Kong at 1 site in Hong Kong.
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 6 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 10 Oct 2018. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingxiao Yang (+852-6316 1954, mingxiaoyang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cohen's kappa coefficient (time frame: baseline). 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 10 Oct 2018.