Stroke
Conditions
Keywords
acupuncture, swallowing impairment
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.
Interventions
OTHERVerum 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.
OTHERSham 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.
OTHERSham 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.
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
In this study, the participants, assessor, and statistician are all blinded to the treatment assignments except for the acupuncturist and study coordinator.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| dysphagia severity rating scale (DSRS) | baseline, the 2nd week of the intervention, 1st and 4th week of follow-up period | 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. |
| the functional oral intake scale (FOIS) | baseline, the 2nd week of the intervention, 1st and 4th week of follow-up period | 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. |
Countries
Taiwan
Contacts
Primary ContactHung-Rong Yen
Outcome results
None listed