NCT03702699

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

October 3, 2018

Last Update Submit

October 8, 2018

Conditions

Osteoarthritis, Knee

Keywords

auricular point detectionknee osteoarthritispain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • the Visual Analogue Scale (VAS)

    baseline

  • the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    baseline

  • the Knee Injury and Osteoarthritis Outcome Score (KOOS)

    baseline

  • self-developed questionnaire on patient's attitude towards complementary therapies for pain management

    baseline

  • The diagnostic specificity of the device

    baseline

  • +1 more secondary outcomes

Study Arms (2)

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

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

Interventions

Auricular point detectorDEVICE

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

Control groupKOA group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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;
  • Provide written inform consent;
  • Free of any other diagnosed psychological conditions;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital, HKU

Hong Kong, INTL, 852, Hong Kong

Location

MeSH Terms

Conditions

Osteoarthritis, KneePain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lixing Lao, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingxiao Yang, PhD

CONTACT

+852 3917 6502mingxiaoyang@hotmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2018

First Posted

October 11, 2018

Study Start

October 15, 2018

Primary Completion

January 31, 2019

Study Completion

March 31, 2019

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations

HK(1)