Complementary Acupuncture Treatment of Dysphagia in Stroke

NCT ID: NCT05429424

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2025-07-31

Brief 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Verum acupuncture group

The study uses manual acupuncture as verum intervention.

Group Type: EXPERIMENTAL

Verum acupuncture group

Intervention Type: OTHER

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 study used specific made needle with a blunt tip, Streitberger device, as sham intervention.

Group Type: SHAM_COMPARATOR

Sham control group I

Intervention Type: OTHER

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

Manual acupuncture at the points unrelated to the dysphagia is another sham intervention in this study.

Group Type: SHAM_COMPARATOR

Sham control group II

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

China Medicine University China Medicine University

Role: STUDY_CHAIR

China Medicine University

Locations

China Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hung-Rong Yen

Role: CONTACT

hungrongyen@gmail.com

04-22053366 ext. 3313

Facility Contacts

Hung-Rong Yen

Role: primary

hungrongyen@gmail.com

04-22053366 ext. 3501

Other Identifiers

CMUH111-REC1-065

Identifier Type: -

Identifier Source: org_study_id