StrokeNCT05429424
Complementary Acupuncture Treatment of Dysphagia in Stroke
A study testing Verum acupuncture group in people with Stroke, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Verum acupuncture group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Feb 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- .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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung
Hung-Rong Yen, 04-22053366 ext. 3501, hungrongyen@gmail.com
About this study
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
- Being tested
- Verum acupuncture group, Sham control group I, Sham control group II
- Keywords
- acupuncture, swallowing impairment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum acupuncture groupOther
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 IOther
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 IIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Verum acupuncture group | Experimental | The study uses manual acupuncture as verum intervention. Receives: Other: Verum acupuncture group |
| Sham control group I | Sham comparator | The study used specific made needle with a blunt tip, Streitberger device, as sham intervention. Receives: Other: Sham control group I |
| Sham control group II | Sham comparator | Manual acupuncture at the points unrelated to the dysphagia is another sham intervention in this study. Receives: Other: Sham control group II |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, the 2nd week of the intervention, 1st and 4th week of follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start2 Feb 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- China Medicine University China Medicine University, Study chair, China Medicine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429424
- Sponsor's protocol ID
- CMUH111-REC1-065
- Status last verified
- Feb 2023
- First submitted
- 12 Jun 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary Acupuncture Treatment of Dysphagia in Stroke
- ClinicalTrials.gov ID
- NCT05429424
- Acronym / sponsor ID
- CMUH111-REC1-065
- Conditions
- Stroke
- Keywords
- acupuncture, swallowing impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Verum acupuncture group | Experimental | Other: Verum acupuncture groupThe study uses manual acupuncture as verum intervention. |
| Sham control group I | Sham comparator | Other: Sham control group IThe study used specific made needle with a blunt tip, Streitberger device, as sham intervention. |
| Sham control group II | Sham comparator | Other: Sham control group IIManual acupuncture at the points unrelated to the dysphagia is another sham intervention in this study. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- .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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verum acupuncture groupThe 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. | Other | Verum acupuncture group |
| Sham control group IThe 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. | Other | Sham control group I |
| Sham control group IIThe 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. | Other | Sham control group II |
Primary outcome
dysphagia severity rating scale (DSRS)
Time frame: 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)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
China Medicine University China Medicine University study chair
China Medicine University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum acupuncture group in people with Stroke, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung-Rong Yen (04-22053366 ext. 3313, hungrongyen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dysphagia severity rating scale (DSRS) (time frame: baseline, the 2nd week of the intervention, 1st and 4th week of follow-up period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.