Biofeedback physical regulation of hypertension based on acupoints: A clinical trial

Abstract

Background: Hypertension is a predominant risk factor for cardiovascular disease and has imposed a global disease burden. Poor medication compliance is the major obstacle to antihypertensive drug therapy, and negative mood status is also detrimental to blood pressure (BP) management. While transcutaneous electrical acupoint stimulation (TEAS), as an electrical stimulation modality for biofeedback physical regulation based on acupoints, offers a such nondrug alternative option that is noninvasive, safe, and effective with high adherence. However, the optimal stimulation parameters of TEAS for hypertension remain unclear, especially the frequency, which needs further exploration. Objective: The study aims to investigate the efficacy of TEAS for hypertension, and to screen the optimal electrical stimulation frequency. Methods: This is an 8-week, randomized, controlled pilot trial with 3 parallel groups. In a ratio of 1:1:1, 120 patients with stage 1 hypertension will be divided into the TEAS-2Hz group, TEAS-10Hz group, or usual care group. All patients will receive the usual care for hypertension including lifestyle education, etc. Additionally, the 2 TEAS groups will receive 12 sessions of TEAS interventions at 2 Hz or 10 Hz, 3 times weekly for 30 minutes each, with 4 weeks of follow-up. The main outcome will be the change from baseline to week 4 in systolic BP among the groups. Secondary outcomes consist of changes in diastolic BP, mean arterial pressure, heart rate, heart rate variability, medication adherence, and quality of life. The safety outcomes will be any adverse event during the treatment. Discussion: As a pre-study for the next large clinical trial of TEAS for hypertension, this study will offer references for optimized frequency of biofeedback electrical devices and promote more consciousness of the benefits of body-mind holistic regulation of BP, thereby achieving proactive and overall process management of BP.