Comparative Effectiveness and Safety of Percutaneous Balloon Compression Versus Conventional Radiofrequency Thermocoagulation for Classic Trigeminal Neuralgia: A Randomized Clinical Trial.

内容摘要

Trigeminal neuralgia (TN) is a debilitating facial pain syndrome. Percutaneous balloon compression (PBC) and conventional radiofrequency thermocoagulation (CRF) are widely used for drug-refractory TN, but randomized evidence comparing their efficacy and safety remains limited. To compare the efficacy, safety, and mechanistic correlates of PBC vs CRF in patients with primary TN. Prospective, randomized, single-blind, controlled trial. The Pain Medicine Unit, Department of Anesthesiology, at a tertiary care medical institute in the Republic of India. Sixty adults with primary TN refractory to &#x2265; 2 medications were randomized 1:1 to PBC or CRF, stratified by age (< 60 or &#x2265; 60 years). PBC was performed via the Hartel approach with 0.8 mL contrast inflation and 90-second compression; CRF involved fluoroscopy-guided, electromyography-confirmed lesioning at 65&#xb0;C and 70&#xb0;C for 60 seconds. Independent blinded assessors recorded Numeric Rating Scale pain scores at baseline, and at postprocedure days 7, 30, 60, 90, and 180. Secondary outcomes included the Barrow Neurological Institute Pain Intensity Score, Brief Pain Inventory (BPI), Douleur Neuropathique 4 Questionnaire (DN4Q), the Pain Catastrophizing Scale (PCS), and safety measures. Correlations between balloon pressures at the beginning (P1) and end of compression (P2) or nerve division involvement and outcomes were analyzed. Baseline characteristics were comparable. Both the groups achieved significant pain relief at 6months, but PBC yielded superior outcomes in Numeric Rating Scale scores (mean &#xb1; SD) (1.4 &#xb1; 0.98 vs 2.35 &#xb1; 1.09; P = 0.002) and BNI (1.75 &#xb1; 0.91 vs 2.28 &#xb1; 0.76; P = 0.01). Improvement in BPI, DN4Q and PCS were similar. Safety was excellent; transient mild masseter weakness was more common with PBC at day 7 (30% vs 3.3%, P = 0.005) but resolved by day 30. Corneal sensation and other cranial nerve functions were preserved. Balloon pressures showed weak, nonsignificant correlations with 6-month outcomes; nerve division involvement had no correlation with the outcome. Single-center design and short 6-month follow-up. PBC provided superior 6-month pain and functional outcomes compared with CRF, with comparable long-term safety. These results support PBC as the preferred percutaneous intervention for appropriately selected patients with classic TN.