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

• Conditions: Menstrual Migraine
• Interventions: Device: auricular point detection

• Registration Number: NCT03702114
• Lead Sponsor: 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.

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-08
• Last Update Submitted: 2018-10-08
• Study First Posted: 2018-10-10
• Last Update Posted: 2018-10-10
• Study Start: 2018-10-15
• Primary Completion: 2019-01-31
• Study Completion: 2019-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 24

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;

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	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.
MMG group	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.

Primary Outcome Measures

Name	Time	Method
cohen's kappa coefficient	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.

Secondary Outcome Measures

Name	Time	Method
the Modified New England Center of Headache (NECH) headache calendar	baseline	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.
self-developed questionnaire on patient's attitude towards complementary therapies for pain management	baseline	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.
the Visual Analogue Scale (VAS)	baseline	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.
The diagnostic specificity of the device	baseline	The specificity test is a test to validate the ability of a diagnosis to tell the 'non-disease' among those without the disease.
The diagnostic sensitivity of the device	baseline	The sensitivity test is a test to validate the ability of a diagnosis to tell the 'disease' among those with the disease.

Trial Locations

Locations (1)

Queen Mary Hospital, HKU; 🇭🇰 Hong Kong, Intl, Hong Kong