Study on the Evaluation of Various Types of Sham Acupuncture Treatments in Hemiplegic Stroke Patients: The Protocol of a Randomized Clinical Trial

Abstract

Background. Various sham acupuncture devices have been developed and used in studies on acupuncture. However, there is controversy on whether these devices act as an appropriate placebo or control. In particular, validation of sham acupuncture has only been performed in studies involving healthy individuals. In this regard, questions on the suitability of various sham acupuncture treatments in studies involving disease treatment remain unanswered. Therefore, in this study, we would like to investigate the most appropriate sham acupuncture in the research on treatment of hemiplegic stroke. Methods. The proposed study is a single-center, prospective, randomized sequence, participant- and assessor-blinded trial with four parallel arms. A total of 90 participants will be randomly assigned to Group 1, Group 2, Group 3, or Group 4 in a 1 : 1 : 1 : 1 ratio. All groups will be treated with Quchi (LI11) for 20 minutes. Group 1 will be treated with verum acupuncture; Group 2, with Park Sham Device; Group 3, with Streitberger’s needle; and Group 4, with insertion- and removal-type devices. Participants will undergo one treatment session. The primary outcome is Bang’s blinding index. Secondary outcomes are the “Discomfort caused by acupuncture therapy” questionnaire and the Massachusetts General Hospital Acupuncture Sensation Scale index. Immediately after the procedure, all participants will also be monitored for adverse events. Discussion. This study will help identify the optimal sham acupuncture device that can be used for clinical studies on acupuncture treatment in hemiplegic stroke patients. This trial is registered with KCT0002622.