Treating Apoplectic Sequela With Acupuncture: a Randomized Controlled Study

Phase 2

• Conditions: Cerebral Infarction
• Interventions: Other: acupuncture and rehabilitation; Other: acupuncture; Behavioral: rehabilitation

• Registration Number: NCT01003470
• Lead Sponsor: Tianjin University of Traditional Chinese Medicine

Brief 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.

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.

Study Timeline

• Study Start: 2006-10
• Status Verified: 2009-10
• Primary Completion: 2009-10
• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-27
• Last Update Submitted: 2009-10-27
• Study First Posted: 2009-10-28
• Last Update Posted: 2009-10-28
• Study Completion: 2010-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 288

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture and rehabilitation	acupuncture and rehabilitation	-
acupuncture	acupuncture	-
rehabilitation	rehabilitation	-

Primary Outcome Measures

Name	Time	Method
Score of neurological defect	before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.

Secondary Outcome Measures

Name	Time	Method
Visualized anologue score	before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.
Spasm evaluation	before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.
Safety evaluation	before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.

Trial Locations

Locations (1)

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (TCM); 🇨🇳 Tianjin, Tianjin, China