Complementary Acupuncture Treatment of Dysphagia in Stroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Other: Sham control group II; Other: Verum acupuncture group; Other: Sham control group I

• Registration Number: NCT05429424
• Lead Sponsor: China Medical University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-12
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-23
• Status Verified: 2023-02
• Study Start: 2023-02-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 336

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan