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

Journal of acupuncture and meridian studies
January 1, 1970
Jin-Jin Wang et al. (9 authors)
Clinical Trial ProtocolJournal ArticleHuman StudyClinical
Study Details

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

Extracted Claims (13)
InterventionDirectionEndpointPopulationDosageImpactClaim #
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
Abstract

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.

Medical Subject Headings (MeSH)
AdultFemaleHumansMaleMiddle AgedAcupuncture TherapyProspective StudiesRandomized Controlled Trials as TopicSalivationSialorrheaStroke
Study Links
Quality Scores
SafetyNot Assessed
Quality85/10
Research Impact Scores
APT Score0.05
Weight Score1.39
Normalized Score0.57
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