Acupuncture Intervention to Improve Neurological Function and Anti-inflammatory Effect in Acute Ischemic Stroke (ANAIS)

China Medical University

Status: Completed

Conditions: Acupuncture; Acute Ischemic Stroke

Treatments: Procedure: Minimal Acupuncture; Procedure: Traditional Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03097055

CMUH106-REC1-008

Details and patient eligibility

About

This study will have acupuncture intervention in acute ischemic stroke patients and evaluate the effect in neurological function improving by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS), Barthel Index, and antiinflammatory actions by biomarkers.

Full description

Acupuncture Treatment in Stroke is a widely practiced in Taiwan, mainland China, and around the world. The using in stroke group is countless. Numerous clinical trials have been conducted in the medical community to assess efficacy, and the results mostly suggest that acupuncture may be an effective, low side effects adjuvant therapy. Ischemic stroke is also associated with chronic inflammation-related diseases. In recent years, the anti-inflammatory effect of acupuncture was gradually found. So, whether in the basic or in clinical, the investigators can deduce that acupuncture may be helpful for stroke as an adjuvant therapy.

This study evaluates the neurological function of patients with acute stroke by using the widely used National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS) and Barthel Index. Also, the investigators assess the degree of inflammation by biomarkers. Therefore, the purpose of this study is to explore the effect of acupuncture intervention on acute ischemic patients and its relationship in anti-inflammatory actions.

Enrollment: 50 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically diagnosed acute ischemic stroke
• Initial NIHSS between 4~20
• Aged 45 ~ 85

Exclusion criteria

• Hemorrhagic transformation after cerebral infarction, the hemorrhage size estimated to be ≥ 2cm in diameter by brain imaging.
• Any intracranial hemorrhage , except hemorrhagic transformation after cerebral infarction
• Any intracranial operation during acute stage
• Patient using anticoagulants
• Cerebellar infarction
• Special causes of stroke, such as coagulation abnormalities, or arteriovenous malformations
• Epileptic seizures after stroke
• Combined with infection diseases at the time of assessment
• Pregnant or breastfeeding women
• Present mental illness or symptoms and cannot cooperate with the study
• Cannot sign the inform consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Traditional Acupuncture

Experimental group

Description:

Traditional acupoints and traditional "deqi" manipulation

Treatment:

Procedure: Traditional Acupuncture

Minimal Acupuncture

Sham Comparator group

Description:

To avoid traditional acupoints and minimal manipulation

Treatment:

Procedure: Minimal Acupuncture