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Does Placebo Information Affect the Trial Outcomes and Participant Blinding?

Muscle Soreness Clinical Trial

Official title:
Effect of Information on Placebo in the Informed Consent on the Trial Outcomes and Participant Blinding

Clinical Trial Summary

This is a randomised sham-controlled trial involving healthy volunteers to determine the effect of information on placebo, i.e., sham acupuncture, given in the informed consent, on the trial outcomes and blinding status of participants in a trial.

Clinical Trial Description

A total of 89 healthy volunteers will be recruited and randomly allocated to one of the 4 groups at an identical ratio. Four groups differ in acupuncture and placebo information. It is summarized as follows:

1. to receive real acupuncture and to read fully disclosed sham acupuncture information (e.g., fake acupuncture) written in the informed consent

2. to receive real acupuncture and to read partially disclosed sham acupuncture information (e.g., different kind of acupuncture) written in the informed consent

3. to receive sham acupuncture (Park Sham Needle) and to read fully disclosed sham acupuncture information written in the informed consent

4. to receive sham acupuncture to read partially disclosed sham acupuncture information (e.g., different kind of acupuncture) written in the informed consent.

They will read informed consent with differently described placebo information following their allocation. After participants repeatedly lift a dumbbell with their non-dominant arm to induce delayed onset muscle soreness (DOMS) in their biceps brachii, they are given allocated acupuncture treatment once a day for three consecutive days including the very first visit to compare outcomes (i.e., relief of DOMS measured with pressure pain threshold and visual analogue scale) and blinding property (the participants will be asked 'which type of acupuncture do you think you have received?' and choose 1 answer out of real, sham, or don't know options). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04182295
Study type Interventional
Source Kyunghee University
Contact
Status Completed
Phase N/A
Start date October 7, 2019
Completion date December 20, 2019
View Details
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