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Clinical Trial 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 knee osteoarthritis (KOA), as compared with an already commercialized device.


Clinical Trial 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 knee osteoarthritis, as compared with an already commercialized device. The investigators will test if the novel APD could provide a more reliable and quantifiable diagnosis than traditional devices currently available in the market; They 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 knee and lower limb area in the KOA population. As a pilot study, 12 patients with KOA will be recruited from the Department of Anesthesiology, Queen Mary Hospital, 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 Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). 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 knee and the KOOS score and WOMAC score. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03702699
Study type Observational
Source The University of Hong Kong
Contact Mingxiao Yang, PhD
Phone +852 3917 6502
Email mingxiaoyang@hotmail.com
Status Not yet recruiting
Phase
Start date October 15, 2018
Completion date March 31, 2019

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