The purpose of this study is to evaluate the therapeutic effect of acupuncture method of "Xing Nao Kai Qiao" for paralysis as an apoplectic sequela in a multicenter randomized and controlled clinical trial and to compare the efficacy between acupuncture and rehabilitation therapy. In addition, evaluating the trial in the view of medical economics.
This study is a multi-center randomized controlled trial comparing three treatment groups.The trial is completed in the following three hospitals: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (TCM) of China, Tianjin Hospital of TCM of China, and Qingdao Haici Medical group of Shangdong province of China.
The total observation period within this study is 24 weeks for each patient. All patients should remain hemiplegia within 15～90 days after stroke. After randomization the patients will receive 4 sessions of 30 minutes' duration during a period of 4 weeks. The outcome measurement is completed both in the different times as follows: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.
288 patients were randomised into three groups: acupuncture group, rehabilitation group,and acupuncture plus rehabilitation group.The patients in the three groups are blinded as to which treatment method they received. The central randomization is used in this trial, which is performed by the Drug Clinical Research Center of Shanghai University of TCM of China. This trial is performed according to the principles of the Declaration of Helsinki (Version Edinburgh 2000). And the trial protocol has been approved by local institutional review board and ethics committee.
- Acupuncture Device
Intervention Desc: Xing Nao Kai Qiao Acupuncture ARM 1: Kind: Experimental Label: acupuncture
- Rehabilitation Other
Other Names: botulinum toxin injection for post stroke spasticity Intervention Desc: Kinesitherapy ARM 1: Kind: Experimental Label: rehabilitation
- Acupuncture and rehabilitation Other
Intervention Desc: Xing Nao Kai Qiao Acupuncture plus Kinesitherapy ARM 1: Kind: Experimental Label: acupuncture and rehabilitation
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Score of neurological defect||before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.||Yes|
|Secondary||Visualized anologue score||before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.||Yes|
|Secondary||Spasm evaluation||before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.||Yes|