Acupuncture regulation promotes functional recovery in patients with post-stroke hemiplegia: study protocol for a multicenter randomized parallel controlled trial

Acupuncture regulation promotes functional recovery in patients with post-stroke hemiplegia: study protocol for a multicenter randomized parallel controlled trial: Qian-qian Sun, Dan-dan Xie, Jing Tao, Tie-bin Yan, Hui-hua Liu, Qiang Li, Bing-tian Zhang, Jun Xu, Xiao-kuo He



Asia Pacific Journal of Clinical Trials: Nervous System Diseases 2017 2(3):108-116



Background and objectives: Effect of conventional rehabilitation methods is still not satisfactory to patients with post-stroke hemiplegia. Studies have demonstrated that acupuncture can improve motor function in stroke patients. Quchi (LI11) and Zusanli (ST36) are most commonly used in the treatment of post-stroke hemiplegia. We will observe the effects of acupuncture on neural plasticity in patients with post-stroke hemiplegia after acupuncture at Quchi and Zusanli.

Design: This is a prospective multicenter randomized parallel controlled trial.

Methods: The trial will be conducted in Shiyan Taihe Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, and the Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine, China. A total of 210 patients with post-stroke hemiplegia will be randomized into an acupuncture priority group, acupuncture delay group, sham acupuncture priority group, and sham acupuncture delay group (n = 45). On the basis of basic treatment and conventional rehabilitation training, acupuncture (acupuncture priority group and acupuncture delay group) or sham acupuncture (sham acupuncture priority group and sham acupuncture delay group) at Quchi and Zusanli will be performed 15 minutes before conventional rehabilitation training (priority) or 15 minutes after conventional rehabilitation training (delay), once a day for 30 minutes, 5 days per week, for 8 consecutive weeks. Patients will undergo one follow-up assessment for 4 months.

Outcome measures: The primary outcome measure will be the efficacy of the treatment after the 8-week period, stated as a percentage calculated by taking the difference between the final simplified Fugl-Meyer motor function score and the baseline score, and dividing this value by the baseline score. Brunnstrom stage classification, Barthel Index score, and electrophysiological changes will serve as secondary outcome measures.

Discussion: We hope to produce new information leading to improved timing for the combined use of acupuncture and modern rehabilitation therapy, and identify the effects of acupuncture at Quchi and Zusanli on cortical excitability and plasticity.

Ethics and dissemination: The protocols have been approved by the Ethics Committee of Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine) of China (approval No. 2014001-2) on August 26th, 2013. We will submit the trial's results for presentation at international scientific meetings and to peer-reviewed journals. The study design was completed in July 2013. Ethical approval was received in August 2013. Clinical registration was conducted in January–February 2017. Patient recruitment began in March 2017. The follow-up will be completed in September 2018. Data analysis will be conducted in June 2019.

Trial registration: This trial was registered in the Chinese Clinical Trial Registry (registration No. ChiCTR-IPR-17010490) on January 20th, 2017, and in the Acupuncture-Moxibustion Clinical Trial Registry (http://ift.tt/2vnVnr1; identifier: AMCTR-IPR-17000038) on February 7th, 2017.

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