Treating Apoplectic Sequela With Acupuncture: a Randomized Controlled Study

Cerebral Infarction Clinical Trial

Official title:

Treating Apoplectic Sequela With Acupuncture: a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01003470
• Other study ID #: KTRDP- 2006BAI12B02-2
• Status: Recruiting
• Phase: Phase 2
• First received: October 27, 2009
• Last updated: October 27, 2009
• Start date: October 2006
• Est. completion date: October 2010

Study information

• Verified date: October 2009
• Source: Tianjin University of Traditional Chinese Medicine
• Contact: Lixin Fu, M.D.
• Phone: 86-13821316617
• Email: fulixin66[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: October 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Cerebral infarction diagnosed according to the diagnostic standard of western medicine

2. Apoplexy diagnosed according to the diagnostic standard of traditional Chinese medicine for apoplexy

3. Cerebral vascular accident occured in the internal carotid artery system which was verified by cerebral CT or MRI

4. The incidence of apoplexy less than twice and the time of onset 15~3 months

5. Age: 40-75 years, non-limited gender

6. NDS score of limb functional defect =10

7. The patient was alert and the vital signs are stable

8. Participant signed the informed consent form

Exclusion Criteria:

1. TIA or RIND

2. The nerve function defect induced by the cerebral tumor, trauma, parasitic diseases, heart disease and metabolic disorder or hemorrhagic cerebrovascular disease

3. Pregnant or breast-feeding women

4. Complicated with severe primary disease in heart, liver, kidney and hematology system or psychopath

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Other:
• acupuncture
Xing Nao Kai Qiao Acupuncture

Behavioral:
• rehabilitation
Kinesitherapy

Other:
• acupuncture and rehabilitation
Xing Nao Kai Qiao Acupuncture plus Kinesitherapy

Locations

Country	Name	City	State
China	First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (TCM)	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

Shiflett SC. Does acupuncture work for stroke rehabilitation: what do recent clinical trials really show? Top Stroke Rehabil. 2007 Jul-Aug;14(4):40-58. Review. — View Citation

Outcome

Type	Measure	Description	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
Secondary	Safety evaluation		before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.	Yes

External Links

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