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: 1. What factors are associated with adverse postoperative outcomes? 2. What is the occurrence probability of different types of adverse outcomes? The study will record patients' demographic and clinical characteristics, laboratory test results, and conduct follow-ups at 3, 6, and 12 months postoperatively.
Study Type
OBSERVATIONAL
Enrollment
110
The Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
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
Time frame: 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
Time frame: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Masticatory dysfunction (bite force reduction ≥50% or subjective weakness)
Time frame: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
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
Time frame: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Diplopia or hearing loss (rare complications to be recorded)
Time frame: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Postoperative infection (puncture site/intracranial)
Time frame: 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
Time frame: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
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