Condition category
Circulatory System
Date applied
04/04/2016
Date assigned
20/04/2016
Last edited
20/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A stroke is a serious condition where the blood supply to a part of the brain is cut off. Around 80% of strokes are ischemic strokes, in which the arteries that supply the brain with oxygen become narrowed or blocked, causing severely reduced blood flow (ischemia). As we age, a gradual build-up of a sticky substance called plaque can build-up in these arteries. An acute cerebral infarction is a type of ischemic stroke in which these arteries become blocked suddenly by a blood clot, reducing blood flow to the brain (cerebral perfusion) and starving it of oxygen. It has been found that a type of acupuncture called waking up spirit needling can help to improve symptoms in stroke patients. Acupuncture is widely used in stroke treatment, but the way that it works is still unclear. The aim of this study is to find out whether the waking up spirit needling method of acupuncture can help to improve blood flow to the brain and relieve symptoms in stroke patients.

Who can participate? 
Adults who have had a acute cerebral infarction and are experiencing reduced by flow to the brain.

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group receive acupuncture with waking up spirit needling method. Participants in the second group receive twelve hand and foot acupuncture. For all participants, acupuncture sessions take place every day on weekdays, with a break over the weekend, for two weeks and last for around 35 minutes per session. Participants undergo a breathing test while having the blood supply to their brain measured using an ultrasound probe (device which uses sound waves to view the blood vessels that supply the brain) at the start of the study and then again after one and two weeks of treatment. Participants also complete a number of questionnaires in order to find out if their has been any change to their nerve function or ability to complete daily activities.

What are the possible benefits and risks of participating?
It is expected that participants will benefit from relief of pain as well as improved function and strength. There is a small risk that the acupuncture treatment could make participants feel nauseous, faint or experience a temporary increase in pain either during or after treatment. Participants are warned of these potential side-effects before consenting to have acupuncture.

Where is the study run from? 
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University (China)

When is the study starting and how long is it expected to run for? 
April 2016 to May 2017

Who is funding the study? 
The Beijing Municipal Administration of Traditional Chinese Medicine (China)

Who is the main contact? 
Dr shao-song Wang 
13263226224@163.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Wang Shaosong

ORCID ID

Contact details

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Beijing Dongcheng District Backstreet Gallery No. 23
Beijing
100023
China
+86 13 269211249
13263226224@163.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Clinical study to assess the influence of acupuncture with waking up spirit needling method on cerebrovascular reserve capacity of patients with acute cerebral infarction

Acronym

Study hypothesis

Acupuncture with waking up spirit needling method can improve the cerebral vascular reserve (CVR) capacity of patients with acute cerebral infarction, thus reducing the scores of National Institutes of Health Stroke Scale (NIHSS) and preventing the further progression of the disease.

Ethics approval

Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, 30/10/2015, ref: 20151130

Study design

Randomised controlled trial

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 below to request a patient information sheet.

Condition

Acute cerebral infarction

Intervention

Participants are randomly allocated to one of two groups.

Treatment group: Participants receive acupuncture with waking up spirit needling method
1. Acupuncture bloodletting will be conducted at acupoints Baihui (DU20), Sishencong (EX-HN1) or twelve well points, the needle will be withdrawn immediately, and skin around the pin holes be squeezed to exanguinate a few drops of blood.
2. Other points like Renzhong (GV 26), Chengjiang (CV 24), Fengchi (GB 20), Hegu (LI 4), Laogong (PC 8), Taichong (LV 3), and Yongquan (KI 1)will be chosen after the bloodletting to take acupuncture, the needles will be retained for 30 minutes.

Control group: Participants receive twelve hand and foot acupuncture. This involves the acupoints including Quchi (LI 11), Neiguan (PC 6), Hegu (LI 4), Yanglingquan (GB 34), Zusanli (ST 36), and Sanyinjiao (SP 6),which will be chosen to take acupuncture, the needles will be retained for 30 minutes.

Participants in both groups receive treatment once a day on weekdays, with a break at the weekend, for a total of two weeks. Each treatment session lasts approximately 35 minutes, with 5 minutes to place the needles and 30 minutes for the needles to remain in place before removal.

All participants are followed up at 1 and 2 weeks post randomisation.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Cerebral vascular reserve (CVR) capacity is determined using the mean blood flow velocity (MFV) of the middle cerebral arteries, as measured with Transcranial Doppler (TCD) breath holding test at baseline and 2 weeks
2. Breath-holding index (BHI) is measured at baseline and 2 weeks

CVR detection method: Transcranial doppler breath holding test is applied. Patients are instructed how to hold the breath, and then they practice for twice before the detection. Patients take supine position, breath peacefully for 5 minutes. Then two ultrasonic probes of TCD machine (EMS-9W, Nanjing Bang’ao Medical Apparatus Ltd. Co., Nanjing, China) are put on bilateral temporal windows with depth of 50-55 mm to measure the blood velocity of bilateral middle cerebral artery, M1. When the best blood flow signal is obtained, the probes are fixed. The mean blood flow velocity is recorded as patients in a calm state. Then patients are asked to hold breath for at least 15 seconds, and the mean blood flow velocity is recorded again.
CVR = (After holding breath MFV - Before holding breath MFV)/ Before holding breath MFV×100%. CVR function is impaired if CVR is less than 20%.
BHI = (After holding breath MFV- Before holding breath MFV) / Before holding breath MFV×(100/time holding breath).

Secondary outcome measures

1. Nerve function is measured using the national institutes of health stroke scale (NIHSS) at baseline, 1 week and 2 weeks
2. Performance in activities of daily living is measured using the Barthel Index at baseline, 1 week and 2 weeks

Overall trial start date

01/04/2016

Overall trial end date

31/05/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 30 to 80 years old with acute cerebral infarction, and their onset time is less than 7 days
2. Meet the western medicine diagnostic criterion for cerebral infarction issued by American Heart Association/American Stroke Association, AHA/ASA in 2013
3. Meet the traditional Chinese medicine diagnostic criterion developed according to the Stroke Diagnosis and Curative Effect Evaluation Standard (Draft) by State Administration of Traditional Chinese Medicine, Acute Encephalopathy Research Group
4. Diagnosis confirmed by head CT or MRI
5. Confirmed with CVR impairment by breath-holding test
6. With NIHSS score larger than or equal to 5 points, or less than or equal to 20 points, and Glasgow Coma Scale score larger than or equal to 12 points
7. Agree to participant in this trial and assign the informed consent.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Using antithrombotics such as Low Molecular Heparin because of some other disease
2. Carotid artery stenting
3. Serious heart, lung or kidney diseases
4. Do not coordinate the brain ultrasound examination or quantitative score evaluation due to other diseases

Recruitment start date

30/04/2016

Recruitment end date

20/05/2017

Locations

Countries of recruitment

China

Trial participating centre

Beijing Hospital of Traditional Chinese Medicine affiliated to the Capital Medical University
Beijing Dongcheng District Backstreet Gallery No.23
Beijing
100023
China

Sponsor information

Organisation

Research Office of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University

Sponsor details

Dongcheng District Backstreet Gallery No.23
Beijing
100010
China
+86 10 52176520
bjzykyc@163.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

The Beijing Municipal Administration of Traditional Chinese Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Planned publication of study protocol in BMJ Open
2. Planned publication of results paper in BMJ Open
3. Planned publication of 1-2 papers about acupuncture and cerebral vascular capacity in Chinese Core Journals

Intention to publish date

15/08/2017

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes