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

The University of Hong Kong (HKU)

Status: Unknown

Conditions: Menstrual Migraine

Treatments: Device: auricular point detection

Study type: Observational

Funder types: Other

Identifiers

NCT03702114

SCM-ACU-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: 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.

Trial design

24 participants in 2 patient groups

MMG group

Description:

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.

Treatment:

Device: auricular point detection

Control group

Description:

This group includes healthy subject, for whom no treatment will be performed. Only auricular point detection by the auricular point detector will be conducted.

Treatment:

Device: auricular point detection