Intraoral Acupuncture for Sialorrhea in Stroke Patients: a Study Protocol for a Randomized Controlled Trial.
Study Goal
The researchers aimed to compare the effects of intraoral and sham acupuncture in post-stroke sialorrhea (PSS) patients and explore relationships among salivation, drooling severity, frequency, and swallowing function in stroke patients.
Results Summary
The study protocol was described, but no results were reported in the abstract as the trial is prospective and outcomes will be published later.
Population
106 PSS patients and 53 stroke patients without PSS.
Effective Dosage
Not specified
Duration
4 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
intraoral acupuncture | neutral | post-stroke sialorrhea | PSS patients | - | compare the effects | #1 |
sham acupuncture | neutral | post-stroke sialorrhea | PSS patients | - | compare the effects | #2 |
intraoral acupuncture | neutral | salivation and drooling severity and frequency and swallowing function | stroke patients | - | explore relationships among | #3 |
sham acupuncture | neutral | salivation and drooling severity and frequency and swallowing function | stroke patients | - | explore relationships among | #4 |
intraoral acupuncture | neutral | 3-minute saliva weight | PSS patients | - | main evaluation index will be | #5 |
sham acupuncture | neutral | 3-minute saliva weight | PSS patients | - | main evaluation index will be | #6 |
intraoral acupuncture | neutral | 3-minute saliva weight | PSS patients | - | comparing changes in | #7 |
sham acupuncture | neutral | 3-minute saliva weight | PSS patients | - | comparing changes in | #8 |
intraoral acupuncture | neutral | Drooling Severity and Frequency Scale | PSS patients | - | secondary assessment indices will include | #9 |
sham acupuncture | neutral | Drooling Severity and Frequency Scale | PSS patients | - | secondary assessment indices will include | #10 |
intraoral acupuncture | neutral | Functional Oral Intake Scale | PSS patients | - | secondary assessment indices will include | #11 |
sham acupuncture | neutral | Functional Oral Intake Scale | PSS patients | - | secondary assessment indices will include | #12 |
conventional 4-week treatment program | neutral | salivation | stroke patients without PSS | - | compare salivation between | #13 |
IMPORTANCE: Post-stroke sialorrhea (PSS) refers to excessive saliva flowing out the lip border after a stroke. PSS negatively affects patient self-image and social communication and may lead to depression. Limited evidence supports the link between excessive salivation and PSS. No large-scale, strictly controlled randomized controlled trials have shown the effectiveness of acupuncture in treating PSS patients. OBJECTIVE: We aim to compare the effects of intraoral and sham acupuncture in PSS patients and explore relationships among salivation and drooling severity and frequency and swallowing function in stroke patients. DESIGN: Clinical study protocol, SPIRIT compliant. SETTING: Prospective, single-center, randomized, and sham-controlled trial. POPULATION: We will recruit 106 PSS patients 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. EXPOSURES: Intraoral or sham acupuncture. MAIN OUTCOMES AND MEASURES: 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.” RESULTS: The results from this study will be published in peer-reviewed journals. CONCLUSION: 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.