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

Menstrual Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03702114
• Other study ID #: SCM-ACU-03
• Status: Not yet recruiting
• Start date: October 15, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: October 2018
• Source: The University of Hong Kong
• Contact: Mingxiao Yang
• Phone: +852-6316 1954
• Email: mingxiaoyang[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: March 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menstrual Migraine
• Migraine Disorders
• Premenstrual Syndrome

Intervention

Device:
• auricular point detection
This device is only for auricular detection. No additional intervention will be delivered.

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital, HKU	Hong Kong	Intl

Sponsors (3)

Lead Sponsor	Collaborator
The University of Hong Kong	City University of Hong Kong, Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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