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

NCT03702114 | Unknown DMC

• 1 other identifier: SCM-ACU-03
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Menstrual Migraine

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• the Visual Analogue Scale (VAS)

  baseline

• the Modified New England Center of Headache (NECH) headache calendar

  baseline

• self-developed questionnaire on patient's attitude towards complementary therapies for pain management

  baseline

• The diagnostic specificity of the device

  baseline

• The diagnostic sensitivity of the device

  baseline

Study Arms (2)

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

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

Interventions

auricular point detection DEVICE

This device is only for auricular detection. No additional intervention will be delivered.

Control group; MMG group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only female subject will be included in this study because the disease investigated is menstrual migraine.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator
• City University of Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital, HKU

Hong Kong, INTL, 852, Hong Kong

Location

Study Officials

• Lixing Lao

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingxiao Yang

CONTACT

+852-6316 1954; mingxiaoyang@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 10, 2018
• Study Start: October 15, 2018
• Primary Completion: January 31, 2019
• Study Completion: March 31, 2019
• Last Updated: October 10, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)