Plain English Summary
Background and study aims
Dysphagia (difficulties swallowing) is common after stroke, with multiple complications such as pneumonia (lung inflammation), dyspepsia (indigestion) and dehydration. The aim of this study is to assess the effectiveness of He’s santong needling method acupuncture compared with a swallowing rehabilitation training program for dysphagia after stroke.
Who can participate?
Patients with dysphagia after stroke
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in one group receive He's santong needling method acupuncture (2-5 30-minute sessions per week) combined with swallowing rehabilitation, while participants in the other group are treated with swallowing rehabilitation (5 sessions per week). All participants are given 4 weeks of treatment. Swallowing function is assessed at the start of the study and after 4 weeks.
What are the possible benefits and risks of participating?
In addition to basic treatment, the participants receive He’s santong needling method acupuncture which may promote the recovery of swallowing function after stroke. Information obtained from this study may benefit patients with the same condition in the future. During acupuncture, the patients may experience brief pain or soreness, and other possible problems include bleeding, ecchymosis (discoloration of the skin) or paresthesia (prickling or burning) around the spot of the needle.
Where is the study run from?
Beijing Hospital of Traditional Chinese Medicine affiliated to the Capital Medical University (China)
When is the study starting and how long is it expected to run for?
January 2017 to December 2019
Who is funding the study?
Beijing Traditional Chinese Medicine Administration Administrative Project (China)
Who is the main contact?
1. Dr Bin Li
libin@bjzhongyi.com
2. Mr Luo-peng Zhao
zhao_luopeng@163.com
Trial website
Contact information
Type
Public
Primary contact
Dr Bin Li
ORCID ID
Contact details
Beijing Dongcheng District Backstreet Gallery No.23
Beijing
100010
China
+86 (0)18910781852
libin@bjzhongyi.com
Type
Public
Additional contact
Mr Luo-peng Zhao
ORCID ID
Contact details
Beijing Dongcheng District Backstreet Gallery No.23
Beijing
100010
China
+86 (0)17888808581
zhao_luopeng@163.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
000000
Study information
Scientific title
Treatment of dysphagia after stroke with He's santong needling method: a prospective randomized controlled study
Acronym
Study hypothesis
This is a prospective randomized controlled study to evaluate the efficacy of He’s santong needling method acupuncture compared with swallowing rehabilitation in dysphagia after stroke.
Ethics approval
Research Ethics Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, 09/05/2017, ref: 2017BL-013-02
Study design
Prospective randomized controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Dysphagia after stroke
Intervention
A total of 60 volunteers will be recruited and randomly divided into two groups.
The treatment group will receive He’s santong needling method acupuncture, consisting of 2-5 30-minute sessions per week, administered over 4 weeks, combined with swallowing rehabilitation given over 5 sessions per week. Acupuncture points were selected based on the consensus of clinical experiences of acupuncture experts including GB20(fengchi), HT5 (tongli), GV16 (fengfu), TE17 (yifeng), CV23 (liquan), jialianquan, ST40 (fenglong), EX-HN12 (jinjin), EX-HN13 (yuye) and yanhoubi.
The control group will be treated with swallowing rehabilitation for 4 weeks (5 sessions/per week), consisting of preparation phase, swallowing functional training and food swallowing training.
Intervention type
Other
Phase
Drug names
Primary outcome measures
The dynamics of swallowing function, measured using FEES (Fiberoptic Endoscopic examination of Swallowing) and Caiteng 7 Rank (CT7R) at baseline and 4 weeks
Secondary outcome measures
1. Quality of life in patients with dysphagia, measured using SWAL-QOL (Swallowing-Related Quality of Life) at baseline and 4 weeks
2. Swallowing ability, measured using MMASA (The Modified Mann Assessment of Swallowing Ability) at baseline and 4 weeks
3. Function of swallowing muscle, measured using sEMG (Surface Electromyography) at baseline and 4 weeks
Overall trial start date
01/01/2017
Overall trial end date
31/12/2019
Reason abandoned
Eligibility
Participant inclusion criteria
1. Meet the diagnosis criteria of stroke according to “Chinese Cerebrovascular Disease Prevention And Treatment Guidelines (2005)” and are confirmed by head CT or MRI
2. Watian swallowing test score: 3-5
3. Dysphagia during oral and pharyngeal phases
4. Can understand and perform simple instructions issued by the therapist, the abbreviated mental test (AMT) score >7, can cooperate and sit up for 30 minutes alone or with the help
5. Have a good compliance with the observation and evaluation of the researchers and volunteer to complete the tests
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Have a history of swallowing disease or other diseases that affect swallowing such as Myasthenia gravis, Guillain-Barre, head esophageal neoplasms
2. Mental illness and severe heart, lung, or kidney disease
3. Disturbance of consciousness and cognitive impairment, the abbreviated mental test (AMT) score <=7
4. With cardiac pacemaker, metal implants or orthosis, head or neck skin damage, have an allergy to the electrode
Recruitment start date
17/10/2017
Recruitment end date
17/10/2019
Locations
Countries of recruitment
China
Trial participating centre
Luo-peng Zhao
100010
Sponsor information
Organisation
Beijing Hospital of Traditional Chinese Medicine affiliated to the Capital Medical University
Sponsor details
Beijing Dongcheng District Backstreet Gallery No.23
Beijing
100010
China
+86 (0)10 52176636
b_j_zyyy@163.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Beijing Traditional Chinese Medicine Administration Administrative Project
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Outcomes of the trial will be disseminated through peer-reviewed publications. The trialists intend to publish the study protocol by 31/12/2017 and publish the study research data and conclusion on dysphagia after stroke by 31/12/2020.
IPD sharing statement
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/12/2020
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary