Identification of Possible Trigeminal Neuralgia

NCT07453511 | Not Yet Recruiting

• 3 other identifiers: IRAS 357989EDGE 183594CPMS ID 72856
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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:
• Complete the IDTN questionnaire before their clinical appointment (either electronically or on paper)
• Undergo their usual specialist clinical assessment, during which the final diagnosis will be recorded
• Allow the research team to compare questionnaire responses with the specialist diagnosis (the reference standard)

Conditions

Trigeminal Neuralgia (TN); Orofacial Pain; Dental Pain; Questionnaire

Keywords

Trigeminal Neuralgia (TN); Orofacial Pain; Screening Tool; Questionnaire; Dental pain

Outcome Measures

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.

  Day 1 (at the participant's clinic appointment)

Secondary Outcomes (6)

• Positive and Negative Predictive Values

  Day 1

• Receiver operating characteristic (ROC) curve and area under the curve (AUC)

  Day 1

• Internal Consistency Reliability

  Through study completion (after all questionnaires are collected) (average 1 year)

• Test - Retest Reliability

  2-3 days after initial questionnaire completion

• Validity

  Day 1

Study Arms (1)

Adults With Orofacial Pain

Adults aged 18 years or older attending the University COllege London Hospital (UCLH) Facial Pain Service or the Oral Surgery Clinic for their first appointment for facial or oral pain. All participants will complete the IDTN questionnaire before their routine clinical consultation. Their specialist diagnosis (for example, trigeminal neuralgia or other facial/oral pain condition) will be used as the reference standard to assess the accuracy of the questionnaire.

Other: Completion of the IDTN Questionnaire

Interventions

Completion of the IDTN Questionnaire OTHER

There are no interventions because this is an observational validation study. Participants complete a 15-item trigeminal neuralgia screening questionnaire (IDTN) before their clinical appointment.

Adults With Orofacial Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• British Pain Society: collaborator

Study Sites (1)

University College London Hospitals NHS Foundation Trust (UCLH) - Eastman Dental Hospital

London, UK, United Kingdom

Location

Related Publications (7)

• Jafree DJ, Zakrzewska JM, Bhatia S, Venda Nova C. Accuracy of the painDETECT screening questionnaire for detection of neuropathic components in hospital-based patients with orofacial pain: a prospective cohort study. J Headache Pain. 2018 Nov 6;19(1):103. doi: 10.1186/s10194-018-0932-5.

  PMID: 30400770 BACKGROUND

• Teshima T, Zakrzewska JM, Potter R. A systematic review of screening diagnostic tools for trigeminal neuralgia. Br J Pain. 2023 Jun;17(3):255-266. doi: 10.1177/20494637221146854. Epub 2023 Jan 2.

  PMID: 37342400 BACKGROUND

• Hadlaq EM, Khan H, Mubayrik AB, Almuflehi NS, Mawardi H. Dentists' knowledge of chronic orofacial pain. Niger J Clin Pract. 2019 Oct;22(10):1365-1371. doi: 10.4103/njcp.njcp_110_19.

  PMID: 31607725 BACKGROUND

• von Eckardstein KL, Keil M, Rohde V. Unnecessary dental procedures as a consequence of trigeminal neuralgia. Neurosurg Rev. 2015 Apr;38(2):355-60; discussion 360. doi: 10.1007/s10143-014-0591-1. Epub 2014 Nov 25.

  PMID: 25418511 BACKGROUND

• Cruccu G, Finnerup NB, Jensen TS, Scholz J, Sindou M, Svensson P, Treede RD, Zakrzewska JM, Nurmikko T. Trigeminal neuralgia: New classification and diagnostic grading for practice and research. Neurology. 2016 Jul 12;87(2):220-8. doi: 10.1212/WNL.0000000000002840. Epub 2016 Jun 15.

  PMID: 27306631 BACKGROUND

• Zakrzewska JM, Wu J, Mon-Williams M, Phillips N, Pavitt SH. Evaluating the impact of trigeminal neuralgia. Pain. 2017 Jun;158(6):1166-1174. doi: 10.1097/j.pain.0000000000000853.

  PMID: 28114183 BACKGROUND

• Allsop MJ, Twiddy M, Grant H, Czoski-Murray C, Mon-Williams M, Mushtaq F, Phillips N, Zakrzewska JM, Pavitt S. Diagnosis, medication, and surgical management for patients with trigeminal neuralgia: a qualitative study. Acta Neurochir (Wien). 2015 Nov;157(11):1925-33. doi: 10.1007/s00701-015-2515-4. Epub 2015 Sep 2.

  PMID: 26329729 BACKGROUND

MeSH Terms

Conditions

Trigeminal Neuralgia; Facial Pain; Toothache

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases

Study Officials

• Joanna M Zakrzewska

  University College London (UCL) and University College London Hospitals NHS Foundation Trust (UCLH)

  STUDY CHAIR

• Nikolaos Apostolidis

  University College London Hospitals NHS Foundation Trust (UCLH) and University College London (UCL)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanna M Zakrzewska, MD

CONTACT

+44 020 3456 1195; jzakrzewska@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Anonymized IPD and supporting materials will be available 6 months after publication of the main study results and will remain available for up to 5 years thereafter.
• Access Criteria: Access will be provided to qualified researchers for scientifically justified purposes. Requests must be submitted in writing to the Chief Investigator and will be reviewed jointly by the research team and sponsor (UCL). Approved researchers will sign a data sharing agreement and will receive access to anonymized datasets through a secure transfer mechanism.

Locations

GB (1)