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

NCT03702101 | Unknown DMC

• 1 other identifier: SCM-ACU-02
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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 orofacial pain, as compared with an already commercialized device.

Conditions

Orofacial Pain

Keywords

orofacial pain; auricular point; electrical impedance

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 in detecting OFP-related auricular point.

  baseline

Secondary Outcomes (5)

• the Visual Analogue Scale (VAS)

  baseline

• the Penn Facial Pain Scale-Revised (Penn-FPS-R)

  baseline

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

  baseline

• The diagnostic specificity of the device

  baseline

• The diagnostic sensitivity of the device

  baseline

Study Arms (2)

Orofacial pain 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 detector DEVICE

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

Control group; Orofacial pain group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

OFP patients visiting the inpatient or outpatient unit of the Department of Anesthesiology Queen Mary Hospital will be referred to this study by an anesthesiologist.

You may qualify if:

• When pain attacks, the average unilateral orofacial pain severity \>=5 point measured by a 10-point VAS scale;
• Patient with trigeminal neuralgia can be diagnosed according to Trigeminal neuralgia: New classification and diagnostic grading for practice and research (Neurology, 2016);
• Other kinds of orofacial pain can be diagnosed based on the patient's symptoms;
• 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;

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator
• City University of Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital, HKU

Hong Kong, INTL, 852, Hong Kong

Location

MeSH Terms

Conditions

Facial Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lixing Lao, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingxiao Yang, PhD

CONTACT

852-6316 1954; mingxiaoyang@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 10, 2018
• Study Start: October 15, 2018
• Primary Completion: January 31, 2019
• Study Completion: March 31, 2019
• Last Updated: October 10, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)