Treatment of dysphagia after stroke with He's santong needling method
| ISRCTN | ISRCTN68981054 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68981054 |
| Secondary identifying numbers | 000000 |
- Submission date
- 13/09/2017
- Registration date
- 25/09/2017
- Last edited
- 07/09/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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
Contact information
Public
Beijing Dongcheng District Backstreet Gallery No.23
Beijing
100010
China
| Phone | +86 (0)18910781852 |
|---|---|
| libin@bjzhongyi.com |
Public
Beijing Dongcheng District Backstreet Gallery No.23
Beijing
100010
China
| Phone | +86 (0)17888808581 |
|---|---|
| zhao_luopeng@163.com |
Study information
| Study design | Prospective randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Treatment of dysphagia after stroke with He's santong needling method: a prospective randomized controlled study |
| Study objectives | 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(s) | Research Ethics Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, 09/05/2017, ref: 2017BL-013-02 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2017 |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/10/2017 |
| Date of final enrolment | 17/10/2019 |
Locations
Countries of recruitment
- China
Study participating centre
China
Sponsor information
Hospital/treatment centre
Beijing Dongcheng District Backstreet Gallery No.23
Beijing
100010
China
| Phone | +86 (0)10 52176636 |
|---|---|
| b_j_zyyy@163.com | |
"ROR" |
https://ror.org/057vq6e26 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 14/08/2018 | Yes | No |
Editorial Notes
07/09/2018: Publication reference added.
