Acupuncture for Early Parkinson's Motor Symptoms: A Multicenter Randomized Controlled Trial Protocol

Pharmacological treatment of motor disorders in early Parkinson (PD) has reached a bottleneck, and acupuncture as an important component of non-pharmacological therapy has demonstrated therapeutic potential. However, current evidence is limited in both quantity and quality, highlighting the need for further clarification of its efficacy.

A multi-center, investigator and participant blinded, randomized parallel group design was employed. 136 eligible participants were randomly assigned in a 1:1 ratio to either the acupuncture or sham acupuncture group via a central randomization system, received 12 sessions over 4 weeks. The primary outcome was motor function, assessed using the Unified Parkinson's Disease Rating Scale-III (UPDRS-III). Secondary outcomes were objective gait metrics captured with the Ready system, disease stage assessed by the Hoehn and Yahr scale (HY), and quality of life measured by the Activities of Daily Living scale (ADL) and the Parkinson's Disease Questionnaire 39 (PDQ 39). Levodopa dosage was recorded before and after treatment. Assessments were conducted at four time points (weeks 1, 2, 3, and 4), with 8 weeks follow up. Blood samples were collected before and after treatment for LC-MS/MS untargeted metabolomics and deep proteomics analysis.

This study will aim to clarify the efficacy of acupuncture for early PD motor symptoms through an evidence-based randomized controlled trial (RCT), and explore the underlying mechanisms of acupuncture using multi-omics approaches.