Complementary Acupuncture Treatment of Dysphagia in Stroke

Stroke Clinical Trial

Official title:

Complementary Acupuncture Treatment of Dysphagia in Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05429424
• Other study ID #: CMUH111-REC1-065
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: February 2023
• Source: China Medical University Hospital
• Contact: Hung-Rong Yen
• Phone: 04-22053366
• Email: hungrongyen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Taiwanese study pointed out that stroke patients who have language barriers, dysphagia, and aspiration pneumonia are more likely to suffer from prolonged hospitalization. Improvements in dysphagia and subsequent complications in patients should be effective in reducing hospital stays and improving the quality of long-term care. In view of clinical medical needs and policy trends, this study aims to explore the efficacy of using traditional Chinese medicine to treat cerebral apoplexy sequelae in Taiwan. It is expected that through (1) exploration of real-world data analysis, combined with the advantages of Taiwan's biomedical database, data exploration will be carried out to provide big data (2) Multi-center prospective randomized clinical trials, providing clinical evidence of the highest level of evidence in empirical medicine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 336
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• .Patients aged more than 20 years
• The diagnosis of first stroke was established within the six months
• Patients had a score = 25 of Mini-Mental State Examination (MMSE)
• Patients met one or both indications as follows

1. Dysphagia confirmed under the standardized swallowing assessment

2. Nasogastric tube feeding already

Exclusion Criteria:

• Previous history of swallowing disability
• Currently known coagulopathy leading to bleeding disorder.
• Previous surgery of head or neck
• Local infection at or near the acupuncture site is not suitable for acupuncture after physician examination.
• Psychological or behavior disorder
• Currently pregnant or breastfeeding women.
• Previous acupuncture treatment for any indication within 30 days of enrollment.
• Severe chronic or uncontrollable complications interference the processing of the trial

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Verum acupuncture group
The acupuncturist disinfected the skin of the selected acupoints with alcohol, then vertically penetrated the skin with disposable stainless-steel needles (size, brand, Taiwan) to the depth predetermined for each point (between 8-25 mm, depending on the location of the acupoint) and achieved a "deqi" response, often described as a pressure, fullness, or achiness feeling around the acupoints.
• Sham control group I
The needle does not penetrate the skin and retract in the handle while the acupuncturist needling into the skin. The participants easily believe their intervention owing to the sensation of needling into the skin that the device mimics. The needles were fixed with a plastic ring and micropore on the body of the participants without manipulation.
• Sham control group II
The acupuncturist disinfected the skin of the selected acupoints with alcohol, then vertically penetrated the skin with disposable stainless-steel needles (size, brand, Taiwan) to the depth predetermined for each point (between 8-25 mm, depending on the location of the acupoint) and achieved a "deqi" response, often described as a pressure, fullness, or achiness feeling around the acupoints.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dysphagia severity rating scale (DSRS)	dysphagia severity rating scale(DSRS) indicates the feeding status of the dysphagia patient in three subdomains: fluids, diet, and level of supervision required for feeding. The total score from 0 to 12. The higher scores means the better outcome.; Changes from baseline to the 2nd week of the intervention, the 1st and 4th week of follow-up period.	baseline, the 2nd week of the intervention, 1st and 4th week of follow-up period
Primary	the functional oral intake scale (FOIS)	the functional oral intake scale(FOIS) is used to assessing the functional level of oral intake of food and liquid in stroke patients. It is a 7-point scale, with level 1 indicating complete impairment of oral intake, and level 7 indicating complete oral intake regardless of food consistency or type.; Changes from baseline to the 2nd week of the intervention, the 1st and 4th week of follow-up period.	baseline, the 2nd week of the intervention, 1st and 4th week of follow-up period