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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Bin Li
Public

Beijing Dongcheng District Backstreet Gallery No.23
Beijing
100010
China

Phone +86 (0)18910781852
Email libin@bjzhongyi.com
Mr Luo-peng Zhao
Public

Beijing Dongcheng District Backstreet Gallery No.23
Beijing
100010
China

Phone +86 (0)17888808581
Email zhao_luopeng@163.com

Study information

Study designProspective randomized controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleTreatment of dysphagia after stroke with He's santong needling method: a prospective randomized controlled study
Study objectivesThis 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) studiedDysphagia after stroke
InterventionA 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 typeOther
Primary outcome measureThe dynamics of swallowing function, measured using FEES (Fiberoptic Endoscopic examination of Swallowing) and Caiteng 7 Rank (CT7R) at baseline and 4 weeks
Secondary outcome measures1. 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 date01/01/2017
Completion date31/12/2019

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants60
Key inclusion criteria1. 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 criteria1. 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 enrolment17/10/2017
Date of final enrolment17/10/2019

Locations

Countries of recruitment

  • China

Study participating centre

Luo-peng Zhao
100010
China

Sponsor information

Beijing Hospital of Traditional Chinese Medicine affiliated to the Capital Medical University
Hospital/treatment centre

Beijing Dongcheng District Backstreet Gallery No.23
Beijing
100010
China

Phone +86 (0)10 52176636
Email b_j_zyyy@163.com
ROR logo "ROR" https://ror.org/057vq6e26

Funders

Funder type

Government

Beijing Traditional Chinese Medicine Administration Administrative Project

No information available

Results and Publications

Intention to publish date31/12/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planOutcomes 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 planThe 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.