Clinical trial NCT01003470: Treating Apoplectic Sequela With Acupuncture: a Randomized Controlled Study
Official title: Treating Apoplectic Sequela With Acupuncture: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cerebral Infarction
Keywords: cerebral infarction
Paralysis
acupuncture
rehabilitation
trial
Lead sponsor: Tianjin University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2009-10-28
Enrollment: 288
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Score of neurological defect
timeFrame: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.
Secondary outcomes:
measure: Visualized anologue score
timeFrame: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.
measure: Spasm evaluation
timeFrame: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.
measure: Safety evaluation
timeFrame: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.
Other outcomes:
Locations:
city: Tianjin
country: China
facility: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (TCM)
state: Tianjin
Study officials:
affiliation: State Administration of Traditional Chinese Medicine of China
name: Sicheng Wang, Master
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1310/tsr1404-40.