Detecting Auricular Points Among Patients With Orofacial Pain 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 is a pilot diagnostic accuracy study conducted to assess the diagnostic ability of a novel APD for auricular point detection among patients with orofacial pain, as compared with an already commercialized device.
详细描述
The present study is a pilot diagnostic accuracy study conducted to assess the diagnostic ability of a novel APD for auricular point detection among patients with orofacial pain (OFP), as compared with an already commercialized device. This study will examine if the novel APD is more reliable than the traditional devices currently available in the market. Moreover, this study will also use the APD device to test the cutaneous electrical impedance of the ear and further assess whether the orofacial auricular points is with the lowest electrical impedance in the OFP population. This pilot study will enroll 12 OFP patients from the Department of Anesthesiology, Queen Mary Hospital, the University of Hong Kong. 12 healthy subjects will be recruited as control from the university community. Auricular acupoint detection will be accomplished with the new device and a control device. The electrical impedance will be detected and recorded. Patient's condition will also be evaluated by the Penn Facial Pain Scale-Revised (2018). 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 of the orofacial area and the Penn Facial Pain Scale score.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •When pain attacks, the average unilateral orofacial pain severity >=5 point measured by a 10-point VAS scale;
- •Patient with trigeminal neuralgia can be diagnosed according to Trigeminal neuralgia: New classification and diagnostic grading for practice and research (Neurology, 2016);
- •Other kinds of orofacial pain can be diagnosed based on the patient's symptoms;
- •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 in detecting OFP-related auricular point.
次要结局
- the Visual Analogue Scale (VAS)(baseline)
- the Penn Facial Pain Scale-Revised (Penn-FPS-R)(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)