Efficacy and safety of acupuncture for post-stroke dysphagia: Protocol for a multicenter, single-blinded, randomized controlled trial

Introduction: Post-stroke dysphagia (PSD), a common and intractable complication of stroke, has attracted considerable endeavors in developing suitable therapies. Acupuncture may be an effective adjunctive treatment for dysphagia, but high-quality evidence of acupuncture is insufficient. Additionally, most studies of acupuncture for PSD did not focus on the acute phase of stroke. Methods: This study is a multi-centered, single-blinded, randomized clinical trial. 300 PSD patients will be randomly allocated in a ratio of 1: 1 to the experimental group (acupuncture combined with basic treatment) and control group (sham acupuncture combined with basic treatment). Both groups will be given the intervention for two weeks (five times/ week). The primary outcome measure is the Functional Oral Intake Scale (FOIS). The secondary outcomes are the Water Swallowing Test (WST), Volume-Viscosity Swallow Test (V-VST), Fiberoptic Endoscopic Evaluation of Swallowing (FEES), Standardized Swallowing Assessment (SSA), Swallowing Quality of Life Questionnaire (SWAL-QOL), Nutrition Risk Screening (NRS-2002), National Institute of Health Stroke Scale (NIHSS), Patient Reported Outcome (PRO) and incidence of pneumonia. Outcomes will be evaluated at baseline, post-treatment, and other time points within two weeks. All primary analyses will be carried out on the basis of the intention-to-treat and per-protocol analysis. Discussion: This trial will explore the effectiveness of acupuncture on improving swallowing function, reducing associated complications, and improving the quality of life for acute stroke patients. Trial registration: Chinese clinical trial registry, ChiCTR1900028061. Registered on 09 Dec 2019, https://www.ch ictr.org.cn/hvshowproject.aspx?id=20881.