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This clinical study aims to investigate adverse outcomes following percutaneous balloon compression (PBC) of the trigeminal ganglion, establish a predictive model, and assess the probability of postoperative complications.The main question it aims to answer is:
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| Measure | Description | Time Frame |
|---|---|---|
| Pain recurrence (BNI≥Ⅲ) | BNI Pain Intensity Scale Score: I:No pain,no medication II:Occasional pain,not requiring medication III:Some pain,adequately controlled with medication IV:Some pain,not adequately controlled with medication V:Severe pain/no pain relief | Follow-up timepoints: 3, 6, and 12 months postoperatively (final determination based on preliminary observation endpoints) |
| Severe sensory impairment (facial numbness with BNI sensory score ≥ Grade III) | BNI Pain Intensity Scale Score: I:No pain,no medication II:Occasional pain,not requiring medication III:Some pain,adequately controlled with medication IV:Some pain,not adequately controlled with medication V:Severe pain/no pain relief | 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints). |
| Masticatory dysfunction (bite force reduction ≥50% or subjective weakness) | 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints). |
| Measure | Description | Time Frame |
|---|---|---|
| Mild sensory abnormalities (BNI sensory score Grade II) | BNI Pain Intensity Scale Score: I:No pain,no medication II:Occasional pain,not requiring medication III:Some pain,adequately controlled with medication IV:Some pain,not adequately controlled with medication V:Severe pain/no pain relief | 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints). |
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Inclusion criteria:
Exclusion criteria:
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Patients who underwent PCGG surgery at the Pain Department of Affiliated Hospital of Nantong University between 2022 and 2024 and were willing to participate in postoperative follow-up were selected as the study subjects.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Nantong University | Nantong | Jiangsu | 211600 | China |
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| Diplopia or hearing loss (rare complications to be recorded) | 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints). |
| Postoperative infection (puncture site/intracranial) | 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints). |
| Psychological status (change in HADS score) | he HADS (Hospital Anxiety and Depression Scale) is a self-assessment questionnaire used to screen for anxiety (HADS-A) and depression (HADS-D) in patients, with each subscale ranging from 0 (no symptoms) to 21 (severe symptoms). A score ≥8 on either subscale suggests clinically significant symptoms. Key features: 14 items (7 for anxiety, 7 for depression) Simple & fast (takes ~5 min) Designed for non-psychiatric medical settings Example scoring: 0-7: Normal 8-10: Mild 11-14: Moderate 15-21: Severe | 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints). |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |