Невральная стимуляция вегетативного нерва без внедрения для хронической мышечно-скелетной боли

Краткое описание

Хроническая мышечно-скелетная (МСК) боль влияет на оценку от 20-33% населения мира и часто ассоциируется с дисфункцией вегетативной нервной системы, которая проявляется симптомами, такими как orthostatic intolerance, palpitations, gastrointestinal dysmotility и fatigue. Конвенциональные методы лечения часто не могут справиться с этим вегетативным компонентом, ограничивая их эффективность. Этот пилотный исследовательский проект investigates, whether non-invasive vagus nerve stimulation (nVNS) using the gammaCore Sapphire device can reduce autonomic symptom severity and improve pain in adults with chronic MSK pain and confirmed autonomic dysfunction. RESTORE-MSK is a randomised, single-blind, sham-controlled, crossover pilot study. Twelve participants with chronic MSK pain (lasting 12 weeks or longer) and autonomic dysfunction (COMPASS-31 score of 17 or more) will be recruited from musculoskeletal clinics at Chapel Allerton Hospital, Leeds. Participants will be randomly allocated to receive either active nVNS or sham stimulation first, followed by a 2-week washout period, then crossover to the alternative treatment. Each treatment period lasts 14 days, with participants self-administering the device twice daily (morning and evening). The primary outcome is change in autonomic symptom severity measured by the Composite Autonomic Symptom Score-31 (COMPASS-31). Secondary outcomes include physiological response to the NASA Lean Test, pain severity and interference (Brief Pain Inventory), anxiety and depression (Hospital Anxiety and Depression Scale), quality of life (EQ-5D-5L), intervention acceptability, and recruitment feasibility. This pilot study aims to establish feasibility and proof of concept for a larger randomised controlled trial investigating nVNS as a non-pharmacological treatment option for chronic MSK pain with autonomic dysfunction.