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Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial
- Source :
- Trials, Trials, Vol 18, Iss 1, Pp 1-10 (2017)
- Publication Year :
- 2017
- Publisher :
- BioMed Central, 2017.
-
Abstract
- Background Stroke is the prime cause of morbidity and mortality in the general population, and hypertension will increase the recurrence and mortality of stroke. We report a protocol of a pragmatic randomized controlled trial (RCT) using blood pressure (BP)-lowering acupuncture add-on treatment to treat patients with hypertension and stroke. Methods This is a large-scale, multicenter, subject-, assessor- and analyst-blinded, pragmatic RCT. A total of 480 patients with hypertension and ischemic stroke will be randomly assigned to two groups: an experimental group and a control group. The experimental group will receive “HuoXueSanFeng” acupuncture combined with one antihypertensive medication in addition to routine ischemic stroke treatment. The control group will only receive one antihypertensive medication and basic treatments for ischemic stroke. HuoXueSanFeng acupuncture will be given for six sessions weekly for the first 6 weeks and three times weekly for the next 6 weeks. A 9-month follow-up will, thereafter, be conducted. Antihypertensive medication will be adjusted based on BP levels. The primary outcome will be the recurrence of stroke. The secondary outcomes including 24-h ambulatory BP, the TCM syndrome score, the Short Form 36-item Health Survey (SF-36), the National Institute of Health Stroke Scale (NIHSS), as well as the Barthel Index (BI) scale will be assessed at baseline, 6 weeks and 12 weeks post initiating treatments; cardiac ultrasound, carotid artery ultrasound, transcranial Doppler, and lower extremity ultrasound will be evaluated at baseline and 12 weeks after treatment. The safety of acupuncture will also be assessed. Discussion We aim to determine the clinical effects of controlling BP for secondary prevention of stroke with acupuncture add-on treatment. Trial registration ClinicalTrials.gov, ID: NCT02967484. Registered on 13 February 2017; last updated on 27 June 2017. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2171-5) contains supplementary material, which is available to authorized users.
- Subjects :
- medicine.medical_specialty
China
Time Factors
Population
Acupuncture Therapy
Medicine (miscellaneous)
Blood Pressure
030204 cardiovascular system & hematology
law.invention
03 medical and health sciences
Study Protocol
0302 clinical medicine
Randomized controlled trial
Clinical Protocols
law
Recurrence
Acupuncture
Secondary Prevention
Medicine
Humans
Pharmacology (medical)
Prospective Studies
Prospective cohort study
education
Stroke
Antihypertensive Agents
lcsh:R5-920
education.field_of_study
business.industry
medicine.disease
Combined Modality Therapy
Transcranial Doppler
Blood pressure
Secondary prevention of stroke
Treatment Outcome
Research Design
Ambulatory
Hypertension
Physical therapy
lcsh:Medicine (General)
business
030217 neurology & neurosurgery
RCT
Subjects
Details
- Language :
- English
- ISSN :
- 17456215
- Volume :
- 18
- Database :
- OpenAIRE
- Journal :
- Trials
- Accession number :
- edsair.doi.dedup.....6b9a4f80a87f109a3bd3d7f16647b530