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Complementary Acupuncture Treatment of Dysphagia in Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Verum acupuncture group
Sham control group I
Sham control group II
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring acupuncture, swallowing impairment

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Sham Comparator

Arm Label

Verum acupuncture group

Sham control group I

Sham control group II

Arm Description

The study uses manual acupuncture as verum intervention.

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 12, 2022
Last Updated
February 6, 2023
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05429424
Brief Title
Complementary Acupuncture Treatment of Dysphagia in Stroke
Official Title
Complementary Acupuncture Treatment of Dysphagia in Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
acupuncture, swallowing impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
336 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Verum acupuncture group
Arm Type
Experimental
Arm Description
The study uses manual acupuncture as verum intervention.
Arm Title
Sham control group I
Arm Type
Sham Comparator
Arm Description
The study used specific made needle with a blunt tip, Streitberger device, as sham intervention.
Arm Title
Sham control group II
Arm Type
Sham Comparator
Arm Description
Manual acupuncture at the points unrelated to the dysphagia is another sham intervention in this study.
Intervention Type
Other
Intervention Name(s)
Verum acupuncture group
Intervention Description
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
Intervention Name(s)
Sham control group I
Intervention Description
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
Intervention Name(s)
Sham control group II
Intervention Description
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.
Primary Outcome Measure Information:
Title
dysphagia severity rating scale (DSRS)
Description
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.
Time Frame
baseline, the 2nd week of the intervention, 1st and 4th week of follow-up period
Title
the functional oral intake scale (FOIS)
Description
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.
Time Frame
baseline, the 2nd week of the intervention, 1st and 4th week of follow-up period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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 Dysphagia confirmed under the standardized swallowing assessment 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hung-Rong Yen
Phone
04-22053366
Ext
3313
Email
hungrongyen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
China Medicine University China Medicine University
Organizational Affiliation
China Medicine University
Official's Role
Study Chair
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung-Rong Yen
Phone
04-22053366
Ext
3501
Email
hungrongyen@gmail.com

12. IPD Sharing Statement

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Complementary Acupuncture Treatment of Dysphagia in Stroke

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