Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Queen Mary Hospital, Hong Kong | OTHER |
| City University of Hong Kong | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KOA group | Patients in this group will receive auricular point detection which is accomplished by the novel auricular point detector device. There is no addition to the patient's routine care. |
| |
| Control group | This group includes healthy subject, for whom no treatment will be performed. Only auricular point detection by the auricular point detector will be conducted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular point detector | Device | This device is only for auricular detection. No additional intervention will be delivered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline |
| the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
KOA patients with surgical schedule will be referred to this study by an anesthesiologist from the inpatient or outpatient unit of the Department of Anesthesiology Queen Mary Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingxiao Yang, PhD | Contact | +852 3917 6502 | mingxiaoyang@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lixing Lao, PhD | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital, HKU | Hong Kong | INTL | 852 | Hong Kong |
The IPD sharing depends on the discretion of participants and principal investigator.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| 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. | baseline |
| self-developed questionnaire on patient's attitude towards complementary therapies for pain management | 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. | 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. | 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. | baseline |
| D012216 |
| Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |