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

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.

Study Overview

• Status: Unknown
• Conditions: Menstrual Migraine
• Intervention / Treatment: Device: auricular point detection

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 Type: Observational
• Enrollment (Anticipated): 24

Contacts and Locations

Study Locations

• Hong Kong
  • Intl
    • Hong Kong, Intl, Hong Kong, 852
      • Queen Mary Hospital, HKU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Eligible menstrual migraine patients will be recruited from the Sassoon Road Clinic of the School of Chinese Medicine, the University of Hong Kong.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; This group includes healthy subject, for whom no treatment will be performed. Only auricular point detection by the auricular point detector will be conducted.	Device: auricular point detection; This device is only for auricular detection. No additional intervention will be delivered.
MMG group; 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.	Device: auricular point detection; This device is only for auricular detection. No additional intervention will be delivered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Queen Mary Hospital, Hong Kong; City University of Hong Kong
• Investigators: Principal Investigator: Lixing Lao, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2018
• Primary Completion (Anticipated): January 31, 2019
• Study Completion (Anticipated): March 31, 2019

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (Actual): October 10, 2018

Study Record Updates

• Last Update Posted (Actual): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: diagnostic accuracy; menstrual migraine; auricular point; Auricular Point Detection device
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Menstruation Disturbances; Migraine Disorders; Premenstrual Syndrome
• Other Study ID Numbers: SCM-ACU-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD sharing will be at the discretion of the study-involved participants and the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No