NCT03702101

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

Detecting Auricular Points Among Patients With Orofacial Pain by A Novel Auricular Point Detector (APD): A Pilot Diagnostic Accuracy Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 24 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

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.

Conditions

• Orofacial Pain

Interventions

Type	Name	Description
DEVICE	Auricular point detector	This device is only for auricular detection. No additional intervention will be delivered.

Timeline

• Start date: 2018-10-15
• Primary completion: 2019-01-31
• Completion: 2019-03-31
• First posted: 2018-10-10
• Last updated: 2018-10-10

Locations

1 site across 1 country: Hong Kong