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

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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Auricular point detector

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.

• Study Type: Observational
• Enrollment (Anticipated): 24

Contacts and Locations

Study Locations

• Hong Kong
  • Intl
    • Hong Kong, Intl, Hong Kong, 852
      • Queen Mary Hospital, HKU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Auricular point detector; This device is only for auricular detection. No additional intervention will be delivered.
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.	Device: Auricular point detector; This device is only for auricular detection. No additional intervention will be delivered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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
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.	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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Queen Mary Hospital, Hong Kong; City University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2018
• Primary Completion (Anticipated): January 31, 2019
• Study Completion (Anticipated): March 31, 2019

Study Registration Dates

• First Submitted: October 3, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: knee osteoarthritis; pain; auricular point detection
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: SCM-ACU-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The IPD sharing depends on the discretion of participants and principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No