Intracranial Hemorrhages
Conditions
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
Interventions
PROCEDUREAcupuncture
Applied acupuncture on specific acupoints in patient with acute intracranial hemorrhage.
PROCEDURESham Acupuncture(Superficial Acupuncture)
Applied superficial acupuncture on specific acupoints in patient with acute intracranial hemorrhage.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Barthel Index | 3 weeks and follow-up for one year | The Barthel Index is a scale used to measure performance in activities of daily living (ADL). The total score can range from 0 (complete dependence) to 100 (complete independence), providing a quantitative measure of an individual's functional independence. |
| Muscle Power | 3 weeks and follow-up for one year | Muscle power is often assessed using a grading system. The most common is the Medical Research Council (MRC) Scale, which grades muscle strength on a scale from 0 to 5 and the lower scores mean the worse outcome. |
| The Modified Rankin Scale | 3 weeks and follow-up for one year | The Modified Rankin Score (mRS) is a scale with scores ranging from 0 to 6, the higher scores mean the worse outcome. |
| National Institute of Health Stroke Scale | 3 weeks and follow-up for one year | The total NIHSS score can range from 0 to 42, where a score of 0 means no stroke symptoms, and a higher score indicates a more severe stroke. |
| Glasgow Coma Scale(GCS) | 3 weeks and follow-up for one year | The Glasgow Coma Scale(GCS) is a clinical scale used to reliably measure a person's level of consciousness. The total score can range from 3 to 15, and the lower scores mean the worse outcome. |
| Karnofsky Performance Scale | 3 weeks and follow-up for one year | The Karnofsky Performance Score (KPS) ranking runs from 100 to 0, where 100 is perfect health and 0 is death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Creatinine | 3 weeks and follow-up for one year | Measuring the level of creatinine in blood. (Crea, mg/dL) |
| Pulse analysis system (PPAS-96)(Sphygmography) | 3 weeks and follow-up for one year | Pulse analysis system (PPAS-96) can realize the digitization of pulse wave graphics, establish a pulse wave database (scale unit: Hertz, Hz). |
| Potassium | 3 weeks and follow-up for one year | Measuring the level of potassium in blood. (K, milliequivalent (mEq)/L) |
| Sodium | 3 weeks and follow-up for one year | Measuring the level of sodium in blood. (Na, milliequivalent (mEq)/L) |
| Completed blood count (CBC) | 3 weeks and follow-up for one year | Measuring the amounts of red blood cells (RBC, million/μL), white blood cells (WBC, 1000/μL), platelets (Plt, 1000/μL), along with the hemoglobin (Hb, g/dL) and hematocrit (Hct, %) values via automated hematology analyzer. |
| White blood cells differential count | 3 weeks and follow-up for one year | Calculating the percentage of each type of white blood cell (WBC): Segment(%), Band(%), Lymphocyte(%), Monocyte(%), Eosinophil(%), Basophil(%) |
| C reactive protein (CRP) | 3 weeks and follow-up for one year | Measuring the level of C reactive protein in blood. (CRP, mg/L) |
| Albumin | 3 weeks and follow-up for one year | Measuring the level of albumin in blood. (Alb, g/dL) |
| Blood urea nitrogen (BUN) | 3 weeks and follow-up for one year | Measuring the level of blood urea nitrogen. (BUN, mg/dL) |
Countries
Taiwan
Contacts
Primary ContactYan Ru Ko
Outcome results
None listed