Background: Acupuncture is safe and effective for reducing the symptoms of knee osteoarthritis (KOA), but the\nunderlying mechanisms of acupuncture for treating KOA are not fully understood.\nMethods/design: In total, 108 participants diagnosed with KOA will be recruited. They will be blinded to group\nassignment and randomized to either verum acupuncture, sham acupuncture or waiting-list groups with 36 patients\nin each group. Each patient in the acupuncture group will receive five treatments per week for 2 weeks. This study will\nfocus on detecting the cerebral functional connectivity changes elicited by acupuncture treatment. The Visual Analog\nScale and the short form of the McGill Pain Questionnaire, the Western Ontario and McMaster Universities\nOsteoarthritis Index, the Attention Test Scale, the Pain Assessment of Sphygmomanometer and the 12-Item\nShort Form Health Survey will be used to evaluate the symptoms and quality of life improvement at the\nbaseline and the end of treatment. The Self-rating Anxiety Scale and the Self-rating Depression Scale will be\nused at the baseline and the end of treatment to investigate the influence of emotional state on brain activity\nand clinical variable. To ensure the consistency of acupuncture manipulation, the deqi scale will be performed after\neach acupuncture treatment. During the procedure of outcome evaluation and data analysis, the evaluators and\nstatisticians will be blinded to the group allocation. The repeated measures analysis of variance (3 groups * 2\ntime points ANOVA) will be employed to analyze numerical variables of the clinical and neuroimaging data\ngenerated in the study, then the t test will be used in the post-hoc analysis.\nDiscussion: The results of this randomized, sham- and waiting-list-controlled functional magnetic resonance\nimaging (fMRI) study will help to investigate the influence of verum acupuncture treatment on the brain activities\nof patients with KOA, which might provide evidence for the clinical application of verum acupuncture for KOA\nmanagement.
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