Detecting Auricular Points in KOA by a Novel APD

NCT ID: NCT03702699

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2019-03-31

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.

Conditions

Osteoarthritis, Knee

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Auricular point detector

Intervention Type: DEVICE

This device is only for auricular detection. No additional intervention will be delivered.

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.

Auricular point detector

Intervention Type: DEVICE

This device is only for auricular detection. No additional intervention will be delivered.

Interventions

Auricular point detector

This device is only for auricular detection. No additional intervention will be delivered.

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queen Mary Hospital, Hong Kong

OTHER

Sponsor Role: collaborator

City University of Hong Kong

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lixing Lao, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Queen Mary Hospital, HKU

Hong Kong, INTL, Hong Kong

Countries

Hong Kong

Central Contacts

Mingxiao Yang, PhD

Role: CONTACT

mingxiaoyang@hotmail.com

+852 3917 6502

Other Identifiers

SCM-ACU-01

Identifier Type: -

Identifier Source: org_study_id