Study Protocol for Multi-Center, Open-Label, Randomized Controlled Trial for Assessing the Efficacy and Safety of Electroacupuncture for Cold Hypersensitivity in Hands and Feet.

Abstract

Objectives: Cold hypersensitivity in the hands and feet (CHHF) is defined as the symptom of a sensation of coldness in the extremities under conditions that are not considered cold by an unaffected person. CHHF can affect the quality of life by placing restrictions on one's daily activities. Although electroacupuncture (EA) and acupuncture have been widely used for treating CHHF, randomized clinical trial (RCT) has not yet been conducted for evaluating the safety and efficacy of EA or acupuncture for the treatment of CHHF. This study aims to evaluate the effects of EA in CHHF patients.

Methods: This study is a randomized, multicenter, and parallel design clinical trial. Overall, 72 participants will be randomly assigned to the EA treatment group, acupuncture treatment group, and untreated control group in 111 ratio via a web-based randomization system. The EA treatment group and acupuncture treatment group will receive EA or acupuncture treatment by visiting ten times at intervals of twice a week for five weeks. Follow-up visits will be made four weeks after the end of treatment. For the untreated control group, three visits will be made. The primary outcome measures will be the CHHF visual analogue scale score. Secondary outcome measures will be the body temperature of hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale abbreviated version, the results of the questionnaire of health-related quality of life, questionnaire of demonstration, and questionnaire of cold hypersensitivity.

Conclusion: This study will be the first clinical trial to evaluate the efficacy and safety of EA for the treatment of CHHF. We expect this study to provide basic evidence for the treatment of CHHF with EA and future large-scale RCTs.