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

Analysis Of The Effectiveness Of a New Placebo Acupuncture Device In Healthy Individuals: A random study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-108f6gyv
Enrollment
Unknown
Registered
2021-09-30
Start date
2020-01-06
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acupuncture analgesia

Interventions

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
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 Acupun
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.
24507

Sponsors

Universidade Federal de Sergipe
Lead Sponsor
Universidade Federal de Sergipe
Collaborator

Eligibility

Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers; over 18 years of age; who have never received acupuncture treatment; and who sign the free and informed consent form

Exclusion criteria

Exclusion criteria: Pregnant women; puerperal women; subjects with infectious processes; skin lesions in the puncture region; nervous tissue disease; inability to understand the instructions for the study; psychiatric diseases; presence of auditory; visual; communicative or cognitive disorders

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactUniversidade de Sergipe
fisio.lagarto@gmail.com+55-079-36317195

Outcome results

None listed

Source: REBEC (via WHO ICTRP)