RESUMEN
Introduction: Parkinson's disease (PD)-related chronic pain is a prevalent non-motor symptom, this study aimed to detect the effect and safety of fire needling therapy (FNT) for PD-related chronic pain relief. Methods: Patients with PD-related chronic pain were randomly allocated to FNT group and control group with a treatment phase of 8 weeks and a follow-up phase of 4 weeks. Primary outcome was the King's Parkinson's Pain Scale (KPPS), Secondary outcomes included Visual Analogue Scale (VAS), Unified Parkinson's Disease Rating Scale-III (UPDRS-III), and the Parkinson's Disease Questionnaire-39 (PDQ-39). Study was registered on Chinese Clinical Trial Registry (Registered number: ChiCTR2400084951). Results: 60 participants were randomized, with 30 in the FNT group and 30 in the control group. KPPS was significantly influenced by the interaction of treatment and time, with a significant reduction in pain observed in the FNT group compared to the control group at Week 4 (difference [95% CI]: -20.693[-27.619,-13.767], P<0.001), Week 8 (difference [95% CI]: 44.680[-52.359,-37.000], P<0.001), and Week 12 (difference [95% CI]: -44.982[-52.771,-37.193], P<0.001). For VAS, UPDRS-III, and PDQ-39, there were significant differences between groups at Week 4, Week 8, and Week 12. Conclusion: FNT could be an effective and safe method for managing PD-related chronic pain. However, large-sample studies conducted in multiple centers are necessary to further verify the findings in the future.