Scalp acupuncture for dyskinesia after ischemic stroke: Study protocol for a parallel randomized controlled clinical trial

Abstract

Background: Scalp acupuncture formed by combining traditional Chinese acupuncture techniques and modern theories in medical anatomy has been widely used to treat ischemic stroke in China, but effective clinical trials that verify its efficacy are lacking. This study proposes to verify the effects of Lu's scalp acupuncture on ischemic stroke by comparing differential improvement of motor function between conventional rehabilitation alone and conventional rehabilitation with Lu's scalp acupuncture. Methods/Design: We will conduct a randomized, controlled, parallel, clinical trial. We will collect 116 ischemic stroke patients with dyskinesia from Longhua Hospital, Shanghai University of Traditional Chinese Medicine and Huashan Hospital, Fudan University in China. All patients will be equally randomized into either a control group (conventional rehabilitation) or an experimental group (scalp acupuncture + conventional rehabilitation). In the control group, patients will receive conventional rehabilitation according to the Guidelines for Stroke Rehabilitation in China. In the experimental group, conventional rehabilitation will be supplemented with oblique acupuncture at approximately 30° and an insertion depth of 25–35 mm in the anterior oblique line of vertex-temporal (MS6). Twisting speed will be 200 times per minute. Acupuncture will be performed 30 minutes, once per day. Patients in both groups will receive rehabilitation five times per week for 8 consecutive weeks. The primary outcome will be the difference in Fugl-Meyer assessment motor function score between posttreatment (4 weeks, 8 weeks, and 6 months of follow-up) and baseline. The secondary outcomes will be differences in the Modified Barthel Index, stroke-specific quality of life, and stroke syndrome of traditional Chinese medicine. Discussion: This trial will provide objective data on the effectiveness of scalp acupuncture in ischemic stroke patients with dyskinesia. Trial registration: ClinicalTrials.gov identifier: NCT03120650. Ethics: The study protocol has been approved by the Ethics Committee of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine of China on 23 October 2013, approval number 2013LCSY056. Informed consent: Written informed consent will be provided by subject guardians.