NCT03702114

Detecting Auricular Points in MMG by a Novel APD ( APD-MMG )

Detecting Auricular Points Among Patients With Menstrual Migraine by A Novel Auricular Point Detector (APD): A Pilot Diagnostic Accuracy Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 24 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Menstrual Migraine

Interventions

Type	Name	Description
DEVICE	auricular point detection	This device is only for auricular detection. No additional intervention will be delivered.

Timeline

• Start date: 2018-10-15
• Primary completion: 2019-01-31
• Completion: 2019-03-31
• First posted: 2018-10-10
• Last updated: 2018-10-10

Locations

1 site across 1 country: Hong Kong