Efficacy and safety of electroacupuncture at auricular concha region in promoting of rehabilitation of ischemic stroke patients with upper limb motor dysfunction: A study protocol for a randomized pilot trial.

Introduction: Ischemic stroke (IS) is the one of the most severe neurological disease, survivors may live with upper limb motor dysfunction (ULMD) resulting in heavy social and economic burden. Nowadays, there are few approaches to promote the rehabilitation of ULMD. Auricular acupuncture (electroacupuncture [EA]) has long been used in the treatment of neurological disorders in China. This treatment has become an attractive treatment option due to its low cost, portability, minimal side effects, and ease of use in clinical and operational environments. However, its efficacy and safety in consciousness recovery remain to be proved.

Methods: A total of 80 IS patients with single upper limb motor function impairment will be recruited in the trial and randomized into EA or control groups. Patients in the control group will receive routine conventional treatment alone while patients in the EA group will receive EA treatment for 3 consecutive weeks based on routine conventional treatment. Baseline evaluation was carried out on day of enrollment, post-treatment evaluation was carried out 14 and 21 days after enrollment, and the 2 groups were follow-ups in 3 and 6 months after the end of the trial. The efficacy will be assessed with the changes in the upper limb Fugl-Meyer assessment, Wolf motor function test, action research arm test, active range of motion, and Barthel index. The safety of EA will be estimated by monitoring the incidence of adverse events and changes in vital signs during the study period. Analysis of feasibility will be descriptive and the change in outcome measures between groups will be analyzed using an independent sample t test.

Discussion: This study tried to narrow the evidence gap on the efficacy of EA at the auricular on the recovery of ULMD in patients with IS. The results of this trial will provide strong evidence for the efficacy and safety of EA of auricular concha region stimulation for IS patients.Trial registration: This trial has been registered at the Chinese Clinical Trial Registry, numbered ChiCTR2100049678.