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Does Placebo Information Affect the Trial Outcomes and Participant Blinding?

NCT04182295 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2020-09-02

No results posted yet for this study

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.

Conditions

  • Muscle Soreness

Interventions

DEVICE

acupuncture

A sterilised stainless steel needle (diameter 0.25mm X length 40mm, Dongbang Acupuncture Inc., Boryeong, Chungchenongnam-do, Korea) will be given at PC3, LI4, LI11, and LU5 of non-dominant arm for 15 minutes once a day for 3 days (immediately after inducing delayed onset muscle soreness (DOMS), and 2 consecutive days after inducing DOMS).

DEVICE

Park Sham Needle

A Park Sham Needle (Meridius Medical Ltd. \& DongBang Acuprime Ltd., Exeter, UK), non-penetrating sham acupuncture, will be given at two points on the belly of biceps brachii, 1 cun proximedially from LI11, and 1 cun laterally from PC3 of non-dominant arm for 15 minutes once a day for 3 days (immediately after inducing delayed onset muscle soreness (DOMS), and 2 consecutive days after inducing DOMS).

Sponsors & Collaborators

  • University of California, Davis

    collaborator OTHER

  • Kyunghee University

    lead OTHER

Principal Investigators

  • Hyangsook Lee, Doctor · Kyunghee University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2019-12-20
Completion
2019-12-20

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04182295 on ClinicalTrials.gov