Intraoral Acupuncture for Sialorrhea in Stroke Patients: a Study Protocol for a Randomized Controlled Trial

Background: Post -stroke sialorrhea (PSS) refers to excessive saliva flowing out of the lip border after a stroke. PSS negatively affects patient self-image and social communication and may lead to depression. Commonly used treatments for reducing salivation have various adverse effects and may be unsuitable for stroke patients. Additionally, limited evidence supports the link between excessive salivation and PSS. Intraoral tongue acupuncture is an alternative therapeutic approach for decreasing sialorrhea in children. However, no large-scale, strictly controlled randomized controlled trials have shown the effectiveness of acupuncture in treating PSS patients. We aim to compare the effects of intraoral and sham acupuncture in PSS patients and explore the relationships among salivation and drooling severity, frequency, and swallowing function in stroke patients. Methods: We will recruit 106 PSS patients for this prospective, single -center, randomized, and sham -controlled trial, randomly assigned to receive 4 -week intraoral or sham acupuncture. Additionally, 53 stroke patients without PSS will undergo a conventional 4 -week treatment program to compare salivation between PSS and non-PSS patients. Follow-up will be conducted for 4 weeks post -intervention. The main evaluation index will be the 3 -minute saliva weight (3MSW), comparing changes in 3MSW from baseline to weeks 4 and 8. Secondary assessment indices will include the "Drooling Severity and Frequency Scale" and "Functional Oral Intake Scale." Discussion: Comparing effects of intraoral and sham acupuncture in PSS patients, this study may contribute important evidence for future PSS treatment and provide valuable insights into whether salivation issues in stroke patients are attributed to heightened salivary secretion or dysphagia.