Developing a Clinical Prediction Model for Adverse Outcomes in Percutaneous Trigeminal Ganglion Balloon Compression
- Conditions
- Trigeminal Neuralgia (TN)
- Registration Number
- NCT06998420
- Lead Sponsor
- Affiliated Hospital of Nantong University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain recurrence (BNI≥Ⅲ) Follow-up timepoints: 3, 6, and 12 months postoperatively (final determination based on preliminary observation endpoints) 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 reliefSevere sensory impairment (facial numbness with BNI sensory score ≥ Grade III) 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints). 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 reliefMasticatory dysfunction (bite force reduction ≥50% or subjective weakness) 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
- Secondary Outcome Measures
Name Time Method 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) 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints). 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: SevereMild sensory abnormalities (BNI sensory score Grade II) 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints). 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
Trial Locations
- Locations (1)
The Affiliated Hospital of Nantong University
🇨🇳NanTong, Jiangsu, China
The Affiliated Hospital of Nantong University🇨🇳NanTong, Jiangsu, China