Multicenter clinical study of the efficacy and safety of Electroacupuncture Treatment for Coldness of Hand & Feet(Cold Hypersensitivity in Hand & Feet )
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0004306
- Lead Sponsor
- Sangji University Korean Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 72
1. Female aged 19 to 59 years have a complaint of cold hypersensitivity on hands and feet
2. Subject must include at least one or more of the following symptoms below:
• Subject has the symptoms of cold hands and feet in normal temperature which most individuals feel no cold
• Subject has the symptoms of severe cold hands and feet in colder than normal temperature exposure
• Even subject is on the return to a warmer environment, the symptoms of cold hands and feet is not completely
disappeared
3. When subject's VAS(Visual Analogue Scale) of cold hypersensitivity on feet VAS) is 4 or more
4. When subject's both upper arms exposure to room temperature (24?±2), the thermal deviation between the foot (acupuncture point, LR3) with the thigh(acupuncture point, S32) may be higher than 2? or, between the hand (acupuncture point, PC8) with the forearm(acupuncture point, LU4) may be higher than 0.3?
5. Ability to comply with all study-related procedures, medications, and evaluations
6. Ability to give informed consent
- Patients who are admission to calcium antagonists and beta-blockers as a treatment of cold hypersensitivity on hands and feet
- Patients who are having one or more finger gangrene or ulceration
- Patients who are diagnosed by hyperthyroidism or currently medicated to thyroid drugs
- Patients who are diagnosed by Autoimmune disease or having a positive antinuclear antibody(ANA) test
- Patients who are diagnosed by Carpal Tunnel Syndrome or having a positive Tinel's sign and Phalen's tests
- Patients who are diagnosed with Cervical disc herniation or lumbar intervertebral disc herniation
- Patients who are diagnosed with diabetes
- Drug that may affect to the cold hypersensitivity on hands and feet(ex. anticoagulants)
- Moderate level of liver dysfunction(each of AST, ALT greater than 100 IU/L) or kidney dysfunction patient(creatine 2.0mg/dL)
- Due to the behaviour disorder or depression or anxiety neurosis or schizophrenia or serious mental illness, do not cooperate with treatment and follow up
- Diagnosed with moderate anemia and hematologic disorders
(adult non-pregnant women hemoglobin level less than 7g/dL, white blood cell level greater than 11,000/mm3)
- Systolic blood pressure 180mmHg or diastolic blood pressure is greater than 100 mmHg based on average value of at least 2 measurements
- Suspected arrhythmia that showed up on electrocardiogram(ECG) or diagnosed by heart disease, such as, ischemic heart disease
- Alcohol or drug abuse
- Female patients who are pregnant (positive urin - human chorionic gonadotropin) or lactating or have the chances of pregnancy
- Diagnosed with malignant tumors
- Participants in other clinical trials within two months
- Refused to participate in this trials
- Able to understand and speak Korean
- Patients who are judged to be inappropriate for the clinical study by the researchers
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS(Visual Analogue Scale) of cold hypersensitivity on hands and feet
- Secondary Outcome Measures
Name Time Method Questionnaire of WHO Quality of Life Scale Abbreviated Version(WHOQOL-BREF) ,;Temperatures of hand and feet (by check Thermometer);Questionnaire of cold hypersensitivity;Questionnaire of EQ-5D