Validation study comparing a novel sham acupuncture technique with Park sham acupuncture: A randomized controlled trial.

INTRODUCTION: Sham acupuncture serves as a control intervention in acupuncture clinical trials to minimize placebo effects and enhance methodological rigor. However, the commercially available Park sham acupuncture device has several limitations. To address these, a novel noninvasive sham acupuncture device was developed. We evaluated the validity of the new device by comparing it with the widely used Park sham acupuncture device. METHODS: This randomized controlled trial included 66 healthy adults randomly assigned (1:1) to receive the novel or Park sham acupuncture intervention at LI4 and ST36. Immediately after the intervention, participants assessed penetration sensation (perceived sensation of skin penetration), pain, and deqi at each acupoint using an 11-point Numeric Rating Scale (NRS) (0, no sensation or pain; 10, unbearable sensation or pain). Safety was evaluated by monitoring adverse events. RESULTS: The novel and Park sham acupuncture groups showed no significant differences in penetration sensation, pain, or deqi (p>0.05). All mean outcome measure scores were below 1.0 on the NRS, indicating that both devices elicited only minimal sensory responses with no clinically meaningful differences. The novel device was statistically noninferior to the Park sham acupuncture device for penetration sensation, pain, and deqi. No adverse events were reported. CONCLUSION: The novel sham acupuncture device demonstrated comparable validity to the commercially available Park sham acupuncture device, suggesting that it can serve as a valid control in clinical studies evaluating the effects of acupuncture. The novel device is expected to contribute to future research aimed at establishing the scientific evidence base for acupuncture treatment. TRIAL REGISTRATION: Clinical Research Information Service of the Republic of Korea (registration number: KCT0010446, https://cris.nih.go.kr).