A Double-blind Randomized Controlled Exploratory Study on the Blood Pressure Reduction Effect of a Transcutaneous Electrical Nerve Stimulation Wearable Device Applied to Neiguan (PC6) in Patients with Stage 1 Hypertension and Prehypertension

Objectives: This study aimed to evaluate the efficacy and safety of a wearable transcutaneous electrical nerve stimulation (TENS) device applied to Neiguan (PC6) to reduce blood pressure in patients with stage 1 hypertension and prehypertension.Methods: This randomized, double-blind, sham-controlled exploratory trial enrolled 34 participants assigned to either the experimental group (n=17) or the sham control group (n=17) for four weeks of intervention, followed by two weeks of observation. Both the test and sham devices delivered TENS stimulation to Neiguan (PC6), corresponding to the median nerve area. Primary and secondary outcomes included changes in systolic BP (SBP), diastolic BP (DBP), heart rate variability (HRV), Perceived Stress Scale (PSS), and Beck Anxiety Inventory (BAI).Results: The experimental group showed significant reductions in SBP at weeks 2, 4, and 6, with the greatest decrease observed after device discontinuation (change at each time point: 3.84±6.18 mmHg, 5.35±8.24 mmHg, and 6.06±7.02 mmHg; p=0.021, 0.020, and 0.003, respectively). DBP significantly decreased at weeks 4 and 6 (6.13±7.70 mmHg and 3.80±6.03 mmHg; p=0.004 and 0.019, respectively). Although no significant differences were detected between the two groups in blood pressure, the experimental group demonstrated significant improvements in PSS and BAI scores at week 6, with lower anxiety levels than the control group. HRV and vital sign analyses indicated no adverse effects or autonomic imbalance.Conclusion: A wearable TENS device targeting PC6 appears safe and reduces SBP and psychological stress in early-stage hypertension, suggesting its potential as a non-pharmacological treatment option.