Trigeminal Neuralgia (TN)
Conditions
Keywords
Trigeminal neuralgia, PCGG, poor prognosis, Clinical Prediction Model
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.
Interventions
None listed
Sponsors
Affiliated Hospital of Nantong University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with primary trigeminal neuralgia and underwent PBCG at the Pain Department of Affiliated Hospital of Nantong University 2. Age ≥18 years 3. Willing to complete postoperative follow-up
Exclusion criteria
1. Secondary trigeminal neuralgia (e.g., tumor compression, multiple sclerosis) 2. Previous interventional treatments for trigeminal neuralgia 3. Incomplete follow-up data 4. General anesthesia contraindications or significant dysfunction of major organs (cardiac, pulmonary, hepatic, renal) or severe neurological impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 relief |
| Severe 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 relief |
| Masticatory dysfunction (bite force reduction ≥50% or subjective weakness) | 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints). | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mild 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 |
| 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: Severe |
| 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). | — |
Countries
China
Outcome results
None listed