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Efficacy of Acupuncture for Pain in Parkinson's Disease: Study Protocol for a Randomized Controlled Trial
Yixuan Wu1, Fan Zhang1, Liangman Xiao1
1The First Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, People's Republic of China.
Introduction:
Pain in Parkinson's disease (PD) is common and significantly reduces quality of life, yet it is often poorly managed. As current treatments have limitations, acupuncture may offer a non-pharmacological option. This trial aims to evaluate the efficacy and safety of acupuncture versus sham acupuncture for pain in PD.
Material And Methods:
This prospective, double-blind, randomized controlled trial will enroll 66 patients with Parkinson's disease-related pain at the First Affiliated Hospital of Guangzhou University of Chinese Medicine between April 2026 and June 2027. Participants will be allocated via block randomization to either an acupuncture group or a sham acupuncture group. Rigorous blinding of patients, practitioners, outcome assessors, and statisticians will be implemented. Both groups will receive 12 sessions (3 sessions per week for 4 weeks) of their assigned intervention while maintaining stable anti-PD medication. The primary outcome is the change in the King's Parkinson's Disease Pain Scale (KPPS) score. Secondary outcomes include the painDETECT Questionnaire (PD-Q), Unified Parkinson's Disease Rating Scale (UPDRS), 39-item Parkinson's Disease Questionnaire (PDQ-39), Hamilton Depression Rating Scale (HAMD), somatosensory evoked potentials (SSEPs), and serum levels of Tumor Necrosis Factor-alpha (TNF-α), S100 calcium-binding protein B (S100B), and Glial Fibrillary Acidic Protein (GFAP). All analyses will follow the intention-to-treat principle.
Discussion:
Pain in PD is prevalent but undertreated due to limited evidence, invasiveness, or high cost of current therapies. This study aims to determine if acupuncture significantly reduces pain scores compared to sham acupuncture, potentially offering an effective, safe, and cost-effective complementary option. By assessing changes in serum biomarkers, it will also explore whether acupuncture's effects involve modulating neuroinflammation. With its rigorous design, this trial is expected to provide high-level evidence for integrating acupuncture into PD pain management.
Trial Registration:
International Traditional Medicine Clinical Trial Registry (ITMCTR2026000325).