Detecting Auricular Points Among Patients With Menstrual Migraine by A Novel Auricular Point Detector (APD): A Pilot Diagnostic Accuracy Study
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- cohen's kappa coefficient
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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;
排除标准
- •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.
结局指标
主要结局
cohen's kappa coefficient
时间窗: 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.
次要结局
- 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 Visual Analogue Scale (VAS)(baseline)
- The diagnostic specificity of the device(baseline)
- The diagnostic sensitivity of the device(baseline)