Treating Apoplectic Sequela With Acupuncture: a Randomized Controlled Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cerebral Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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acupuncture

Group Type EXPERIMENTAL

acupuncture

Intervention Type OTHER

Xing Nao Kai Qiao Acupuncture

rehabilitation

Group Type ACTIVE_COMPARATOR

rehabilitation

Intervention Type BEHAVIORAL

Kinesitherapy

acupuncture and rehabilitation

Group Type ACTIVE_COMPARATOR

acupuncture and rehabilitation

Intervention Type OTHER

Xing Nao Kai Qiao Acupuncture plus Kinesitherapy

Interventions

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acupuncture

Xing Nao Kai Qiao Acupuncture

Intervention Type OTHER

rehabilitation

Kinesitherapy

Intervention Type BEHAVIORAL

acupuncture and rehabilitation

Xing Nao Kai Qiao Acupuncture plus Kinesitherapy

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No