An observational study in Orofacial Pain, sponsored by The University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-10.
Sponsored by The University of Hong Kong · Observational
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.
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 orofacial pain (OFP), as compared with an already commercialized device. This study will examine if the novel APD is more reliable than the traditional devices currently available in the market. Moreover, this study will also use the APD device to test the cutaneous electrical impedance of the ear and further assess whether the orofacial auricular points is with the lowest electrical impedance in the OFP population. This pilot study will enroll 12 OFP patients from the Department of Anesthesiology, Queen Mary Hospital, the University of Hong Kong. 12 healthy subjects will be recruited as control from the university community. Auricular acupoint detection will be accomplished with the new device and a control device. The electrical impedance will be detected and recorded. Patient's condition will also be evaluated by the Penn Facial Pain Scale-Revised (2018). 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 the orofacial area and the Penn Facial Pain Scale score.
186 studies on the registry are indexed under Facial Pain; 58 are open to participants now.
This study's planned enrollment of 24 is below the median of 135 across 45 observational studies indexed under Facial Pain.
Browse Facial Pain studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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 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.
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.
Time frame: baseline
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.
Time frame: baseline
the Penn Facial Pain Scale-Revised (Penn-FPS-R)
The Penn-FPS-R is a new 12-item Health-Related Quality of Life outcome measure with content validity that can be used to assess and monitor the impact of Trigeminal Neuralgia and facial pain treatment interventions in both clinical practice and research. This scale uses the 0-10 numeric rating scale (NRS) to quantify the pain intensity and its impact on life quality, where 0 indicates no pain/impact and 10 indicates worst pain/impact. The sum of the rated NRS score will be calculated.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline
Plan to share: No — IPD sharing will be at the discretion of the study-involved participants and the principal investigator.
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong