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Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial.
- Source :
- Trials; 9/15/2017, Vol. 18, p1-10, 10p, 1 Diagram, 3 Charts
- Publication Year :
- 2017
-
Abstract
- <bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Discussion: </bold>We aim to determine the clinical effects of controlling BP for secondary prevention of stroke with acupuncture add-on treatment.<bold>Trial Registration: </bold>ClinicalTrials.gov, ID: NCT02967484 . Registered on 13 February 2017; last updated on 27 June 2017. [ABSTRACT FROM AUTHOR]
- Subjects :
- ACUPUNCTURE
BLOOD pressure
STROKE prevention
RANDOMIZED controlled trials
MORTALITY
PHYSIOLOGY
THERAPEUTICS
ANTIHYPERTENSIVE agents
DISEASE relapse prevention
STROKE diagnosis
COMBINED modality therapy
COMPARATIVE studies
EXPERIMENTAL design
HEALTH surveys
HYPERTENSION
LONGITUDINAL method
RESEARCH methodology
MEDICAL cooperation
RESEARCH protocols
QUESTIONNAIRES
RESEARCH
STROKE
TIME
DISEASE relapse
EVALUATION research
TREATMENT effectiveness
BARTHEL Index
NIH Stroke Scale
DISEASE complications
DIAGNOSIS
Subjects
Details
- Language :
- English
- ISSN :
- 17456215
- Volume :
- 18
- Database :
- Complementary Index
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 125197271
- Full Text :
- https://doi.org/10.1186/s13063-017-2171-5