Complementary Acupuncture Treatment of Dysphagia in Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Verum acupuncture group; Other: Sham control group I; Other: Sham control group II

• Study Type: Interventional
• Enrollment (Anticipated): 336
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Recruiting
    • China Medical University Hospital
    • Contact: Hung-Rong Yen; Phone Number: 3501 04-22053366; Email: hungrongyen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Verum acupuncture group; The study uses manual acupuncture as verum 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_COMPARATOR: Sham control group I; The study used specific made needle with a blunt tip, Streitberger device, as sham intervention.	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.
SHAM_COMPARATOR: Sham control group II; Manual acupuncture at the points unrelated to the dysphagia is another sham intervention in this study.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 2, 2023
• Primary Completion (ANTICIPATED): July 31, 2025
• Study Completion (ANTICIPATED): July 31, 2025

Study Registration Dates

• First Submitted: June 12, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (ACTUAL): June 23, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: acupuncture; swallowing impairment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: CMUH111-REC1-065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No