Clinical trial NCT03702101: Detecting Auricular Points in OFP by a Novel APD ( APD-OFP)
Official title: Detecting Auricular Points Among Patients With Orofacial Pain by A Novel Auricular Point Detector (APD): A Pilot Diagnostic Accuracy Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orofacial Pain
Keywords: orofacial pain
auricular point
electrical impedance
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
name: City University of Hong Kong
First posted: 2018-10-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: OFP patients visiting the inpatient or outpatient unit of the Department of Anesthesiology Queen Mary Hospital will be referred to this study by an anesthesiologist.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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;

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;

Primary outcomes:
measure: cohen's kappa coefficient
timeFrame: baseline
Secondary outcomes:
measure: the Visual Analogue Scale (VAS)
timeFrame: baseline
measure: the Penn Facial Pain Scale-Revised (Penn-FPS-R)
timeFrame: baseline
measure: self-developed questionnaire on patient's attitude towards complementary therapies for pain management
timeFrame: baseline
measure: The diagnostic specificity of the device
timeFrame: baseline
measure: The diagnostic sensitivity of the device
timeFrame: baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, HKU
state: Intl
Study officials:
affiliation: The University of Hong Kong
name: Lixing Lao, PhD
role: PRINCIPAL_INVESTIGATOR
References: