Does Placebo Information Affect the Trial Outcomes and Participant Blinding?

Kyung Hee University

Status: Completed

Conditions: Muscle Soreness

Treatments: Device: Park Sham Needle; Device: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04182295

KHSIRB-19-173

Details and patient eligibility

About

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.

Full 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).

Enrollment: 89 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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89 participants in 4 patient groups

real acupuncture-full disclosure

Experimental group

Description:

Participants in this group will be given real acupuncture once a day for three consecutive days including the very first visit and fully disclosed sham acupuncture information in the informed consent (i.e., fake acupuncture).

Treatment:

Device: acupuncture

real acupuncture-partial disclosure

Experimental group

Description:

Participants in this group will be given real acupuncture once a day for three consecutive days including the very first visit and partially disclosed sham acupuncture information in the informed consent (i.e., different kind of acupuncture).

Treatment:

Device: acupuncture

sham acupuncture-full disclosure

Sham Comparator group

Description:

Participants in this group will be given sham acupuncture once a day for three consecutive days including the very first visit and fully disclosed sham acupuncture information in the informed consent (i.e., fake acupuncture).

Treatment:

Device: Park Sham Needle

sham acupuncture-partial disclosure

Sham Comparator group

Description:

Participants in this group will be given sham acupuncture once a day for three consecutive days including the very first visit and partially disclosed sham acupuncture information in the informed consent (i.e., different kind of acupuncture).

Treatment:

Device: Park Sham Needle