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.
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 Type
OBSERVATIONAL
Enrollment
24
This device is only for auricular detection. No additional intervention will be delivered.
Queen Mary Hospital, HKU
Hong Kong, INTL, Hong Kong
cohen's kappa coefficient
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.
Time frame: baseline
the Visual Analogue Scale (VAS)
The VAS is a common instrument used to measure pain intensity. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates worst pain possible.
Time frame: baseline
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a 24-item instrument used to measure pain and joint function among patients with osteoarthritis. For each item, there is a Likert 5-point scale (ranging from 0 to 4), where 0 = none and 4 = extremely. It includes three major domains, including pain, stiffness, and physical function. The total score is calculated as the sum of the items chosen divided by 96.
Time frame: baseline
the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee Injury and Osteoarthritis Outcome Score (KOOS) is a validated 42-item global knee score suitable for comparison of patients with knee complaints attributable to different causes. A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Time frame: baseline
self-developed questionnaire on patient's attitude towards complementary therapies for pain management
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This is a self-developed questionnaire which includes 10 items aiming to survey patient's attitude towards the use of complementary therapies for pain management. This questionnaire only includes descriptive answers to be choose. The percentage for each choice will calculated.
Time frame: baseline
The diagnostic specificity of the device
The specificity test is a test to validate the ability of a diagnosis to tell the 'non-disease' among those without the disease.
Time frame: baseline
The diagnostic sensitivity of the device
The sensitivity test is a test to validate the ability of a diagnosis to tell the 'disease' among those with the disease.
Time frame: baseline