None listed
Conditions
Interventions
Medical Device : This study is a randomized, multi-center, parallel-group, pilot clinical trial designed to evaluate the efficacy of combined electroacupuncture and electric moxibustion for subjects w
Sponsors
Sangji University Korean Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female participants aged between 19 and 59 years who complain of cold hypersensitivity in both upper and lower extremities (hands and feet). 2. Those who meet the following definition and at least one of the scope items: Definition: Individuals who complain of discomfort due to cold sensations in the hands and feet. Scope Items: First, feeling cold in the hands and feet at temperatures where cold is not typically felt. Second, feeling excessive cold in the hands and feet compared to others at temperatures where cold may be felt. Third, symptoms that do not easily recover when moving from a cold environment to a warm environment. 3. Those with a Visual Analogue Scale (VAS) score of 4 or higher for both hand and foot cold hypersensitivity at the time of the screening visit. 4. Those who, after 10 minutes of adaptation to a room temperature of 24°C (±2) with upper and lower limbs exposed, show the following temperature differences as measured by a thermometer: A temperature difference of 0.3°C or more between the center of the bilateral upper arms (LU4) and the palms (PC8). OR a temperature difference of 2.0°C or more between the center of the bilateral anterior thighs (ST32) and the dorsum of the feet (LR3). 5. Those who are available for follow-up during the clinical trial period. 6. Those who have signed the informed consent form voluntarily after receiving a clear explanation of the purpose and characteristics of this clinical study.
Exclusion criteria
Exclusion criteria: 1. Those taking medications that may affect the treatment of cold hypersensitivity, such as vasodilators. 2. Those with one or more ulcers or gangrene on the fingers or toes. 3. Those diagnosed with hypothyroidism or taking thyroid-related medications. 4. Those diagnosed with autoimmune diseases. 5. Those diagnosed with and currently undergoing treatment for carpal tunnel syndrome or tarsal tunnel syndrome, or those who tested positive in the Phalen's or Tinel's test. 6. Those diagnosed with and currently undergoing treatment for cervical or lumbar herniated nucleus pulposus (HNP). 7. Diabetic patients with complications or uncontrolled blood glucose levels. 8. Patients with severe hepatic dysfunction (AST/ALT = 100 IU/L each) or renal failure (Creatinine = 2.0 mg/dL). 9. Those with behavioral disorders, depression, anxiety neurosis, or severe psychiatric disorders. 10. Adult females (non-pregnant) with Hemoglobin < 7 g/dL or WBC = 11,000/mm³. 11. Those with an average systolic blood pressure (SBP) = 180 mmHg or diastolic blood pressure (DBP) = 100 mmHg, measured twice at a 10-minute interval after resting. 12. Those with heart diseases such as arrhythmia requiring treatment or ischemic heart disease according to electrocardiogram (ECG) results. 13. Alcohol or drug abusers. 14. Pregnant women (positive urine hCG test), breastfeeding women, women planning to become pregnant, or women of childbearing potential who do not agree to use appropriate contraceptive methods. 15. Those diagnosed with malignant tumors. 16. Those currently participating in other clinical studies or those within 3 months of completing a clinical trial. 17. Those who refuse to participate in the clinical trial or provide consent. 18. Those who lack the ability to understand or express themselves in Korean. 19. Those judged ineligible for the clinical trial based on the investigator's clinical judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Temperature recovery through lukewarm water load inspection;World Health Organization Quality of Life - BREF(WHOQOL-BREF);EuroQol 5-Dimensions(EQ-5D) | — |
Countries
Korea, Republic of
Contacts
Public ContactHyunjoo Oh
Sangji University
Outcome results
None listed