Detecting Auricular Points Among Patients With Menstrual Migraine by A Novel Auricular Point Detector (APD): A Pilot Diagnostic Accuracy Study
| Registry | NCT03702114 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 24 (Estimated) |
| Sponsor | The University of Hong Kong (Other); collaborators: Queen Mary Hospital, Hong Kong, City University of Hong Kong |
| Conditions | Menstrual Migraine |
| Interventions | auricular point detection (Device) |
| Dates | start 2018-10-15 (estimated), primary completion 2019-01-31 (estimated), completion 2019-03-31 (estimated), first posted 2018-10-10, last updated 2018-10-10 |
| Locations | 1 site in Hong Kong |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| MMG group | Device: auricular point detection | 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. | |
| Control group | Device: auricular point detection | This group includes healthy subject, for whom no treatment will be performed. Only auricular point detection by the auricular point detector will be conducted. |
Sex: Female, ages: 18 Years to 40 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Queen Mary Hospital, HKU | Hong Kong, INTL | Hong Kong |