Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
NCT ID:
NCT02856906
Eligibility Criteria:
Inclusion Criteria:
* The patients claim orofacial pain. The pain has been treated but not relieved by medication, surgery, root canal therapy, even teeth extracting, or the pain relieve effect went down for a period. The patients also match the following item 1 or 2:
* Item 1: disorder characterized by recurrent unilateral brief electric shock-like pains, abrupt in onset and termination, limited to the distribution of one or more divisions of the trigeminal nerve and triggered by innocuous stimuli. It may develop without apparent cause or be a result of another diagnosed disorder. There may or may not be, additionally, persistent background facial pain of moderate intensity.They fulfilled criteria A-E
* At least three attacks of unilateral facial pain fulfilling criteria B and C
* Occurring in one or more divisions of the trigeminal nerve, with no radiation beyond the trigeminal distribution
* Pain has at least three of the following four characteristics:
* recurring in paroxysmal attacks lasting from a fraction of a second to 2 minutes.
* severe intensity.
* electric shock-like, shooting, stabbing or sharp in quality.
* precipitated by innocuous stimuli to the affected side of the face.
* No clinically evident neurological deficit
* Not better accounted for by another the International Classification of Headache Disorders 3rd edition diagnosis.
* Item 2 Persistent facial and/or oral pain, with varying presentations but recurring daily for more than 2 hours per day over more than 3 months, in the absence of clinical neurological deficit.They fulfilled criteria A-E
* Facial and/or oral pain fulfilling criteria B and C
* Recurring daily for \>2 hours per day for \>3 months
* Pain has both of the following characteristics: 1. poorly localized, and not following the distribution of a peripheral nerve 2. Dull, aching or nagging quality
* Clinical neurological examination is normal
* A dental cause has been excluded by appropriate investigations
* Not better accounted for by another the International Classification of Headache Disorders 3rd edition diagnosis
Exclusion Criteria:
* Head and facial trauma; orofacial and/or intracranial space occupying lesion indicated by craniofacial CT ; pain caused by sinusitis and acute pulpitis, periapical periodontitis and periodontitis disease; no occlusal abnormalities and occlusion treatment indications through a series of occlusal examination; children (younger than 18 years old) and pregnant women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02856906
Study Brief:
Protocol Section:
NCT02856906