Stroke
Conditions
Interventions
Control group:In addition to routine treatment, the control group will receive sham needling 5 times per week for 4 weeks and will be assessed accordingly at the designated time points. To ensure blin
Intraoral acupuncture group(treatment group).:In the intraoral acupuncture group, on the basis of conventional treatment, disposable sterile acupuncture needles (0.25mm×75mm with tube) were used to pu
Routine treatment group (no sialorrhea group):Conventional medication, acupuncture on the affected limb, and rehabilitation training were given 5 times per week for 4 weeks.
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with stroke aged between 35 and 75 years; 2. Confirmed diagnosis of ischemic stroke or cerebral hemorrhage based on brain computed tomography or magnetic resonance imaging, with a stable medical condition and clear awareness; 3. Stroke occurrence within the past 6 months; 4. Sialorrhea symptoms for the intraoral acupuncture and control groups, and no sialorrhea symptoms for the routine treatment group; 5. Sufficient cognitive ability to comprehend and follow instructions and a Mini-Mental State Examination score of >= 24; 6. Sialorrhea is not treated with other treatments or other treatments are planned (including drugs that reduce saliva secretion, surgery, and Botox injections); 7. Willingness to participate voluntarily in the research and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. History of sialorrhea; 2. Dysphagia caused by other diseases, including, Parkinson’s disease, malignant throat disease, head and neck radiotherapy history, and tracheotomy; 3. Presence of a concurrent chronic disorder, such as severe motor neuron disease, cardiac blood supply system disease, or cancer; 4. Bleeding tendencies that may pose risks during acupuncture procedures; 5. Known oversensitivity or allergy to acupuncture that may lead to adverse events (AEs); 6. Developmental malformations, including incomplete lip closure and tracheal malformations, which may lead to sialorrhea; 7. Temporomandibular joint disorder and other reasons that may cause difficulty in opening the mouth.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Saliva volume (swab method); | — |
Secondary
| Measure | Time frame |
|---|---|
| Drooling Severity;Swallowing function (Functional Oral Intake Scale); | — |
Countries
China
Contacts
Public ContactHaiyan Li
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed