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

• ClinicalTrials.gov Identifier: NCT03702114
• Recruitment Status: Unknown
• First Posted: October 10, 2018
• Last Update Posted: October 10, 2018
• Sponsor: The University of Hong Kong
• Collaborators: Queen Mary Hospital, Hong Kong; City University of Hong Kong
• Information provided by (Responsible Party): The University of Hong Kong

Study Description

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.

Condition or disease	Intervention/treatment
Menstrual Migraine	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 Design

• Study Type: Observational
• Estimated Enrollment: 24 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Detecting Auricular Points Among Patients With Menstrual Migraine by A Novel Auricular Point Detector (APD): A Pilot Diagnostic Accuracy Study
• Estimated Study Start Date: October 15, 2018
• Estimated Primary Completion Date: January 31, 2019
• Estimated Study Completion Date: March 31, 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :

1. cohen's kappa coefficient [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Only female subject will be included in this study because the disease investigated is menstrual migraine.
• Accepts Healthy Volunteers: Yes
• 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.

Criteria

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.

Contacts and Locations

Contacts

Contact: Mingxiao Yang; +852-6316 1954; mingxiaoyang@hotmail.com

Locations

Hong Kong

Queen Mary Hospital, HKU

Hong Kong, Intl, Hong Kong, 852

Sponsors and Collaborators

The University of Hong Kong

Queen Mary Hospital, Hong Kong

City University of Hong Kong

Investigators

• Principal Investigator: Lixing Lao; The University of Hong Kong

More Information

• Responsible Party: The University of Hong Kong
• ClinicalTrials.gov Identifier: NCT03702114
• Other Study ID Numbers: SCM-ACU-03
• First Posted: October 10, 2018
• Last Update Posted: October 10, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: IPD sharing will be at the discretion of the study-involved participants and the principal investigator.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The University of Hong Kong:

menstrual migraine; auricular point; diagnostic accuracy; Auricular Point Detection device

Additional relevant MeSH terms:

Migraine Disorders; Premenstrual Syndrome; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Menstruation Disturbances; Pathologic Processes