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

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. 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. 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. Chinese clinical trial registry, ChiCTR1900028061. Registered on 09 Dec 2019, https://www.chictr.org.cn/hvshowproject.aspx?id=20881.