Acupuncture for Symptomatic Treatment of Fatigue in Parkinson's Disease: Trial Design and Implementation.

Background: Acupuncture use is increasing worldwide for many conditions, including movement disorders. Clinical research in acupuncture has also increased to test anecdotal reports of clinical benefits empirically and investigate potential mechanisms. Method: This article describes considerations for designing a double-blinded, randomized, placebo-controlled clinical trial of acupuncture for fatigue in Parkinson's disease (PD) and describes the current authors' experience in the implementation and early conduct of this trial. Relevant literature is also reviewed to provide guidance for other researchers seeking to perform clinical research relevant to PD and related disorders. Results: Trial design should be driven by a well-defined research question and sufficient detail to meet Standards for Reporting Interventions in Clinical Trials of Acupuncture criteria when a trial is complete. Important items for review include: randomization and blinding; recruitment and participant selection; sham methodology choice; staff training; and practical implementation of study procedures. Sample forms used for the current authors' trial are shared. Conclusions: High-quality clinical trials of acupuncture can provide valuable information for clinicians, patients, and policymakers. Acupuncture trials differ in critical ways from pharmaceutical trials and might require additional considerations regarding design and implementation. Adequate preparation for the unique challenges of acupuncture studies can improve trial implementation, design, efficiency, and impact.