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

Not Applicable

Completed

• Conditions: Acute Ischemic Stroke; Acupuncture
• Interventions: Procedure: Traditional Acupuncture; Procedure: Minimal Acupuncture

• Registration Number: NCT03097055
• Lead Sponsor: China Medical University, Taiwan

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-03-21
• Study Start: 2017-03-30
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-03-31
• Primary Completion: 2018-12-18
• Study Completion: 2019-09-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-08
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Acupuncture	Traditional Acupuncture	Traditional acupoints and traditional "deqi" manipulation
Minimal Acupuncture	Minimal Acupuncture	To avoid traditional acupoints and minimal manipulation

Primary Outcome Measures

Name	Time	Method
National Institutes of Health Stroke Scale (NIHSS)	1.beginning of stroke (within 3 days after onset); 2.after a 4-weeks acupuncture course (within 7 days after last acupuncture); 3. a month later after acupuncture course (about 28±7 days after last acupuncture)	The NIHSS improving in about a 2-months-period follow up.

Secondary Outcome Measures

Name	Time	Method
inflammatory biomarkers	1.beginning of stroke (within 3 days after onset); 2.after a 4-weeks acupuncture course (within 7 days after last acupuncture); 3. a month later after acupuncture course (about 28±7 days after last acupuncture)	The inflammatory biomarkers changing in about a 2-months-period follow up.
modified Rankin Scale (mRS)	1.beginning of stroke (within 3 days after onset); 2.after a 4-weeks acupuncture course (within 7 days after last acupuncture); 3. a month later after acupuncture course (about 28±7 days after last acupuncture)	The mRS improving in about a 2-months-period follow up.
Barthel Index	1.beginning of stroke (within 3 days after onset); 2.after a 4-weeks acupuncture course (within 7 days after last acupuncture); 3. a month later after acupuncture course (about 28±7 days after last acupuncture)	The Barthel Index improving in about a 2-months-period follow up.

Trial Locations

Locations (1)

Nantou Hospital of the Ministry of Health and Welfare; 🇨🇳 Nantou City, Nantou County, Taiwan