Treating Apoplectic Sequela With Acupuncture: a Randomized Controlled Study
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebral Infarction |
Other: acupuncture Behavioral: rehabilitation Other: acupuncture and rehabilitation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Treating Apoplectic Sequela With Acupuncture: a Randomized Controlled Study |
- Score of neurological defect [ Time Frame: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. ] [ Designated as safety issue: Yes ]
- Visualized anologue score [ Time Frame: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. ] [ Designated as safety issue: Yes ]
- Spasm evaluation [ Time Frame: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. ] [ Designated as safety issue: Yes ]
- Safety evaluation [ Time Frame: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 288 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: acupuncture |
Other: acupuncture
Xing Nao Kai Qiao Acupuncture
|
| Active Comparator: rehabilitation |
Behavioral: rehabilitation
Kinesitherapy
|
| Active Comparator: acupuncture and rehabilitation |
Other: acupuncture and rehabilitation
Xing Nao Kai Qiao Acupuncture plus Kinesitherapy
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Cerebral infarction diagnosed according to the diagnostic standard of western medicine
- Apoplexy diagnosed according to the diagnostic standard of traditional Chinese medicine for apoplexy
- Cerebral vascular accident occured in the internal carotid artery system which was verified by cerebral CT or MRI
- The incidence of apoplexy less than twice and the time of onset 15~3 months
- Age: 40－75 years, non-limited gender
- NDS score of limb functional defect ≥10
- The patient was alert and the vital signs are stable
- Participant signed the informed consent form
Exclusion Criteria:
- TIA or RIND
- The nerve function defect induced by the cerebral tumor, trauma, parasitic diseases, heart disease and metabolic disorder or hemorrhagic cerebrovascular disease
- Pregnant or breast-feeding women
- Complicated with severe primary disease in heart, liver, kidney and hematology system or psychopath
Contacts and Locations| Contact: Lixin Fu, M.D. | 86-13821316617 | fulixin66@126.com |
| China, Tianjin | |
| First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (TCM) | Recruiting |
| Tianjin, Tianjin, China, 300193 | |
| Contact: Lixin Fu, M.D. 86-13821316617 fulixin66@126.com | |
| Study Director: | Sicheng Wang, Master | State Administration of Traditional Chinese Medicine of China |
More Information
Additional Information:
Publications:
| Responsible Party: | Ministry of Science and Technology of the People's Republic of China, State Administration of Traditional Chinese Medicine of China |
| ClinicalTrials.gov Identifier: | NCT01003470 History of Changes |
| Other Study ID Numbers: | KTRDP- 2006BAI12B02-2 |
| Study First Received: | October 27, 2009 |
| Last Updated: | October 27, 2009 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Tianjin University of Traditional Chinese Medicine:
|
cerebral infarction Paralysis acupuncture rehabilitation trial |
Additional relevant MeSH terms:
|
Cerebral Infarction Stroke Infarction Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Ischemia Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on May 16, 2013