Clinical trial NCT03702699: Detecting Auricular Points in KOA by a Novel APD
Official title: Detecting Auricular Points Among Patients With Knee Osteoarthritis by A Novel Auricular Point Detector (APD): A Pilot Diagnostic Accuracy Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis, Knee
Keywords: auricular point detection
knee osteoarthritis
pain
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: 2018-10-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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 knee osteoarthritis (KOA), 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 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.

Eligibility criteria: Inclusion Criteria:

* Average daily knee pain \>=5 point measured by a 10-point VAS scale;
* Diagnosed KOA of any reason;
* The different patient categories;
* Patients with knee osteoarthritis enrolled for knee arthroplasty, osteotomies around the knee, cartilage repair, or anterior cruciate ligament-deficient knees enrolled for anterior cruciate ligament reconstruction;
* Surgical plan in the coming month after inclusion;
* 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 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: baseline
measure: the Knee Injury and Osteoarthritis Outcome Score (KOOS)
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: