Clinical trial NCT04182295: Does Placebo Information Affect the Trial Outcomes and Participant Blinding?
Official title: Effect of Information on Placebo in the Informed Consent on the Trial Outcomes and Participant Blinding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Soreness
Keywords: Placebo
Informed consent
Participant information leaflet
Outcome
Blinding
Sham
Acupuncture
Delayed Onset Muscle Soreness
Lead sponsor: Kyunghee University
Sponsor class: OTHER
Collaborators: name: University of California, Davis
First posted: 2019-12-02
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* age over 18
* not participating in other studies at the time of study participation
* voluntary participation

Exclusion Criteria:

* resistance training for more than 6 months
* experience of fracture of any of four limbs
* pregnancy or breast-feeding at the time of study participation
* analgesics within 24 hours before participation
* any other diseases or conditions that might prevent the participant from receiving acupuncture

Primary outcomes:
measure: the change in muscle discomfort from baseline, i.e., immediately after being induced DOMS, measured by visual analogue scale (VAS)
timeFrame: day 0; day 1; day 2
measure: Blinding property
timeFrame: day 2
measure: the change in Pressure Pain Threshold (PPT) from baseline, i.e., before being induced DOMS
timeFrame: day 0; day 1; day 2
Secondary outcomes:
measure: Acupuncture sensation measured by De-qi questionnaire
timeFrame: day 0; day 1; day 2
Other outcomes:
measure: Acupuncture credibility
timeFrame: day 0; day 2
measure: Acupuncture Belief Scale (ABS)
timeFrame: day 0
measure: State-Trait Anxiety Inventory-X (STAI-X)
timeFrame: day 0
Locations:
city: Seoul
country: Korea, Republic of
facility: Acupuncture & Meridian Science Research Centre
Study officials:
affiliation: Kyunghee University
name: Hyangsook Lee, Doctor
role: PRINCIPAL_INVESTIGATOR
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