Clinical trial NCT06243237: Efficacy of Acupuncture in Patients With Acute Intracranial Hemorrhage
Official title: Efficacy of Acupuncture in Patients With Acute Intracranial Hemorrhage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Hemorrhages
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators propose a research design protocol to evaluate the efficacy of acupuncture in improving function recovery after acute intracranial hemorrhage.

Detailed description: Stroke is a major cause of death and disability. According to the Ministry of Health and Welfare in Taiwan, stroke accounted for 6.8% of all deaths and was the 4th leading cause of death in Taiwan in 2020. Stroke can be divided into acute, subacute, and chronic stages, and the initial severity of stroke affects recovery from sequelae. Therefore, how to effectively improve the sequelae and accelerate the recovery of patients through early interventions is an important issue. This study aimed to investigate the effect of early acupuncture treatment in the acute stage of hemorrhagic stroke. Subjects will be divided into two main groups by random assignment. The intervention group will be treated with traditional acupuncture, while the control group will be treated with pseudo-acupuncture(superficial acupuncture). The treatment frequency was 3 times a week for at least one week. Consciousness, neurological status and disability status were assessed before treatment, at the end of the first week, the second week and the third week, and biomarker were examined before and after treatment

Eligibility criteria: Inclusion Criteria:

* Diagnosis of hemorrhagic stroke by a specialist
* Age over 20 years and below 85 years
* GCS between 5-13

Exclusion Criteria:

* Intracranial hemorrhage resulted from vascular anomalies
* Pregnant patients
* Intracranial tumor related hemorrhage
* Other diseases that can cause neurological deficits, such as old cerebrovascular disease, poliomyelitis, cerebral palsy, spinal cord injury
* Organ damage or terminal illness (heart or kidney failure or malignancy)

Primary outcomes:
measure: Barthel Index
timeFrame: 3 weeks and follow-up for one year
measure: Muscle Power
timeFrame: 3 weeks and follow-up for one year
measure: The Modified Rankin Scale
timeFrame: 3 weeks and follow-up for one year
measure: National Institute of Health Stroke Scale
timeFrame: 3 weeks and follow-up for one year
measure: Glasgow Coma Scale(GCS)
timeFrame: 3 weeks and follow-up for one year
measure: Karnofsky Performance Scale
timeFrame: 3 weeks and follow-up for one year
Secondary outcomes:
measure: Pulse analysis system (PPAS-96)(Sphygmography)
timeFrame: 3 weeks and follow-up for one year
measure: Completed blood count (CBC)
timeFrame: 3 weeks and follow-up for one year
measure: White blood cells differential count
timeFrame: 3 weeks and follow-up for one year
measure: C reactive protein (CRP)
timeFrame: 3 weeks and follow-up for one year
measure: Albumin
timeFrame: 3 weeks and follow-up for one year
measure: Blood urea nitrogen (BUN)
timeFrame: 3 weeks and follow-up for one year
measure: Creatinine
timeFrame: 3 weeks and follow-up for one year
measure: Sodium
timeFrame: 3 weeks and follow-up for one year
measure: Potassium
timeFrame: 3 weeks and follow-up for one year
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Chang-Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yan Ru Ko
role: STUDY_DIRECTOR
References: