Clinical trial NCT03702114: Detecting Auricular Points in MMG by a Novel APD ( APD-MMG )
Official title: Detecting Auricular Points Among Patients With Menstrual Migraine by A Novel Auricular Point Detector (APD): A Pilot Diagnostic Accuracy Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Menstrual Migraine
Keywords: menstrual migraine
auricular point
diagnostic accuracy
Auricular Point Detection device
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
name: City University of Hong Kong
First posted: 2018-10-10
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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.

Primary outcomes:
measure: cohen's kappa coefficient
timeFrame: baseline
Secondary outcomes:
measure: the Visual Analogue Scale (VAS)
timeFrame: baseline
measure: the Modified New England Center of Headache (NECH) headache calendar
timeFrame: baseline
measure: self-developed questionnaire on patient's attitude towards complementary therapies for pain management
timeFrame: baseline
measure: The diagnostic specificity of the device
timeFrame: baseline
measure: The diagnostic sensitivity of the device
timeFrame: baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, HKU
state: Intl
Study officials:
affiliation: The University of Hong Kong
name: Lixing Lao
role: PRINCIPAL_INVESTIGATOR
References: