https://doi.org/10.55788/5794ffe4
NOE-PRO-201 (NCT06019338) was a clinical study assessing the content validity of a new questionnaire-based tool for capturing pain symptoms in patients with trigeminal neuralgia [1]. The TnED© is a daily 5-question diary which inquires about a participant’s paroxysms (severity, frequency), continuous pain (if present, together with severity, duration), and pain interference (from paroxysms and continuous pain). The study assessed no therapeutic agent or other intervention except for the questionnaire. The recall period for the questionnaire questions was 24 hours.
In total, 30 participants were included in the study, 15 with paroxysms and 15 with continuous pain (mean age 54.9 years, 80% women). Most participants found the questionnaire’s content items to be clear, easy to understand, and relevant. Furthermore, the recall period was found suitable, while the questionnaire overall was easy-to-use and the reminders and notifications were suitable. Finally, when asked during individual interviews, participants were happy with the quality of the questionnaire, mentioning convenience over other pain diaries. Participants also suggested improvements, such as inclusion of pain triggers, concomitant medications, and a free-text box, but noted that quantifying the number of attacks can be difficult in times with multiple attacks.
Overall, Dr Amine Tahiri (Noema Pharma, Switzerland) concluded that NOE-PRO-201 has shown content validity of the items that make up the TnED© and that the questionnaire items capture pain both in paroxysmal and continuous concomitant pain, while being convenient for participants. “The results support the validation of the tool and use in clinical trials for trigeminal neuralgia, potentially supporting future use as a companion tool for patients with trigeminal neuralgia communicating their pain burden to care providers.”
- Tahiri SA, et al. Results from study NOE-PRO-001: Content validity of a new tool for collecting daily symptom data in Trigeminal Neuralgia: Trigeminal Neuralgia Pain Electronic Diary (TnED©). 18th European Headache Congress, 4–7 December 2024, Rotterdam, the Netherlands.
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Table of Contents: EHC 2024
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