Identification of Possible Trigeminal Neuralgia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity College, London
About this trial
Trigeminal neuralgia (TN) is a severe type of non-dental orofacial pain that can feel like sudden electric shocks in the face and is often mistaken for tooth pain or other dental problems. This can lead to delays in referral and unnecessary, sometimes irreversible, dental treatment. The goal of this observational study is to evaluate how well a new questionnaire (IDentification of possible Trigeminal Neuralgia - IDTN) identifies adults with possible trigeminal neuralgia among patients attending hospital clinics with orofacial pain, with the aim of supporting its use in dental and general medical practice to improve early recognition and referral.
The main questions it aims to answer are:
* How accurately does the IDTN questionnaire identify patients with possible trigeminal neuralgia compared with the specialist clinical diagnosis? * Which combination of questionnaire items best supports a practical screening score for use in dental and/or general medical practice?
Participants will:
1. Complete the IDTN questionnaire before their clinical appointment (either electronically or on paper) 2. Undergo their usual specialist clinical assessment, during which the final diagnosis will be recorded 3. Allow the research team to compare questionnaire responses with the specialist diagnosis (the reference standard)
A subset of participants will also be asked to complete the questionnaire again a few days later to assess test-retest reliability.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older
Attending the UCLH Facial Pain Service or Oral Surgery Clinic for their first appointment for facial or oral pain following referral from primary care
Disqualifiers
Not experiencing facial or oral pain
Unable to understand English well enough to complete the questionnaire
Lacking capacity to provide informed consent
Insufficient time before their appointment to read the information sheet, provide consent, and complete the questionnaire
Trial population
Participants will be recruited from two clinical settings at University College London Hospitals (UCLH): the Facial Pain Service and the Oral Surgery Clinic. Eligible participants will be identified using clinic codes that indicate first-time attendance for pain-related referrals from primary care. This population includes individuals referred from primary care because of facial pain, dental pain, or suspected orofacial pain conditions, including trigeminal neuralgia.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Completion of the IDTN Questionnaire
Other interventionThere are no interventions because this is an observational validation study. Participants complete a 15-item trigeminal neuralgia screening questionnaire (IDTN) before their clinical appointment.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Adults With Orofacial Pain1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic Accuracy of the IDTN Questionnaire
Sensitivity and specificity of the IDTN screening tool for identifying possible trigeminal neuralgia (TN), using the specialist clinical diagnosis as the reference standard. This will assess how accurately the questionnaire distinguishes between participants with and without possible TN.
Time frame
Day 1 (at the participant's clinic appointment)Secondary outcomes
1
Positive and Negative Predictive Values
Positive predictive value (PPV) and negative predictive value (NPV) of the IDTN questionnaire in identifying possible TN compared with the clinical diagnosis.
Time frame
Day 12
Receiver operating characteristic (ROC) curve and area under the curve (AUC)
The AUC-ROC will be calculated to measure how well the IDTN questionnaire discriminates between participants with and without possible TN.
Time frame
Day 13
Internal Consistency Reliability
Internal consistency of the questionnaire items will be evaluated using Cronbach's alpha to assess whether items measure the same underlying construct.
Time frame
Through study completion (after all questionnaires are collected) (average 1 year)4
Test - Retest Reliability
Stability of questionnaire responses over time will be assessed in a subsample of participants who complete the IDTN questionnaire twice within a few days. Agreement will be measured using intraclass correlation coefficient or Cohen's kappa.
Time frame
2-3 days after initial questionnaire completionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University College, London
Lead sponsor
British Pain Society
Collaborator
Source ClinicalTrials.gov
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