Condition category
Signs and Symptoms
Date applied
13/09/2017
Date assigned
25/09/2017
Last edited
25/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Publication citations

Additional files

Editorial Notes