Effectiveness of a New Placebo Acupuncture Device in Healthy Individuals: A random study

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2021
INTERVENTION: 11350 24507 There will be five study groups, divided into experimental and control groups at acupuncture points LI4 and ST36. The LI4 groups correspond to the experimental group: application of the insertion and withdrawal intervention, composed of 25 participants; Control Group: with the application of the acupuncture sham technique with the Yung Sham device, composed of 25 participants. The groups at point ST36 correspond to the experimental group: Real Acupuncture Intervention, composed of 25 people; Experimental group: Insertion and withdrawal, composed of 24 people. Control Group: Yung Sham, with the application of the acupuncture sham technique with the Yung Sham device, composed of 25 people. Both groups will be composed of healthy individuals, and will be subjected to the application of a real or fake acupuncture technique. CONDITION: 10333 36318 55451 Acupuncture analgesia; Acupuncture therapy; Placebo effect; Healthy volunteers PRIMARY OUTCOME: It is expected to find statistical differences between the experimental groups and the control groups at their respective points, for the subjects' belief in whether or not they received a real intervention or placebo. These data being observed from the value of p <0.05, having a confidence interval of 95%. It is expected to find statistical differences between the experimental groups and the control groups in their respective points, for the sensation of penetration of the self‐reported needle by the volunteer after intervention from the application of the post‐intervention questionnaire. These data will be observed from the value of p <0.05, with a 95% confidence interval. SECONDARY OUTCOME: It is expected to find statistical differences between the experimental groups and the control groups at their respective points, for the pressure pain threshold assessed by the Newtons pressure algometer before and after the intervention. These data will be observed from the value of p <0.05, with a 95% confidence interval. INCLUSION CRITERIA: Healthy volunteers; over 18 years of age; who have never received acupuncture treatment; and who sign the free and informed consent form
Epistemonikos ID: 0c00890cb612cdf7dd9fa968ccda4a9f73a820f4
First added on: Aug 25, 2024