The cerebral mechanism of the specific and nonspecific effects of acupuncture based on knee osteoarthritis: study protocol for a randomized controlled trial

This study will explore the specific and non-specific effects of acupuncture for knee osteoarthritis (KOA) by functional magnetic resonance imaging (fMRI).Methods and designNinety participants diagnosed with KOA will be randomly divided into the acupuncture group, sham acupuncture group, and waiting list group in a ratio of 1:1:1. Except for the waiting list group, the other participants will receive acupuncture or sham acupuncture three sessions per week for 4  weeks respectively. The primary outcome will be the response rate which is defined on an individual basis as at least a 2-point decrease in the numerical rating scale (NRS) of pain at the end of intervention period compared with the baseline. fMRI scans will be performed at baseline and the end o f the intervention period to examine the response of various brain regions. The secondary outcomes will include the Western Ontario and McMaster Osteoarthritis Index (WOMAC), State-Trait Anxiety Scale-State Anxiety Subscale (STAI-S), and Stanford Expectations of Treatment Scale (SETS). Pearson’s c orrelation coefficient will be performed to investigate the changes in brain activity and clinical variables.DiscussionThe results of our study will help to evaluate the specific and nonspecific effects of acupuncture combined with clinical and brain function changes based on KOA.Trial registrationChinese Clinical Trial RegistryChiCTR1900025799. Registered on 9 September 2019.
Source: Trials - Category: Research Source Type: clinical trials