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Completed

NCT Number: NCT04182295

Does Placebo Information Affect the Trial Outcomes and Participant Blinding?

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.

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Key information

Conditions

Muscle Soreness Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acupuncture & Meridian Science Research Centre

Seoul, 02447, South Korea

About this study

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:

  • to receive real acupuncture and to read fully disclosed sham acupuncture information (e.g., fake acupuncture) written in the informed consent
  • to receive real acupuncture and to read partially disclosed sham acupuncture information (e.g., different kind of acupuncture) written in the informed consent
  • to receive sham acupuncture (Park Sham Needle) and to read fully disclosed sham acupuncture information written in the informed consent
  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture

Device

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).

Park Sham Needle

Device

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).

Other names: sham acupuncture

Primary outcomes

  1. the change in muscle discomfort from baseline, i.e., immediately after being induced DOMS, measured by visual analogue scale (VAS)

    Time frame: day 0; day 1; day 2

    Muscle discomfort of DOMS induced arm is evaluated with VAS ranging from 0 to 10 cm (with 0 indicating no discomfort and 10 experiencing the worst imaginable muscle discomfort.)

  2. Blinding property

    Time frame: day 2

    Blinding property is evaluated: participants will be asked 'which type of acupuncture do you think you have received?' and choose 1 answer out of experimental group, control group, and do not know. It is calculated following the way of Bang's Blind Index; -1 indicates opposite guessing; 0 indicates random guessing; 1 indicates correct guessing.

  3. the change in Pressure Pain Threshold (PPT) from baseline, i.e., before being induced DOMS

    Time frame: day 0; day 1; day 2

    Pressure Pain Threshold (PPT) will be evaluated on the 5 points of upper non-dominant arm. Five points are selected from 6 equidistance from origin to insertion of biceps brachii with an exception of the first and last point, perpendicular to the belly of the biceps brachii. Pressure was applied to each of these points with increasing force at a rate of approximately 10 N/cm2*sec until the participant reported a painful sensation, and the force value was recorded (N/cm2). An upper limit of PPt was set 50 N/cm2 to avoid bruising.

Secondary outcomes

  1. Acupuncture sensation measured by De-qi questionnaire

    Time frame: day 0; day 1; day 2

    De-qi questionnaire (Kim et al.) is used to evaluate acupuncture sensation measured in VAS ranging from 0 to 10 cm (with 0 indicating no feeling of respective 18 items included in the questionnaire and 10 experiencing the worst imaginable feeling of respective 18 items included in the questionnaire.)

Other outcomes

  1. Acupuncture credibility

    Time frame: day 0; day 2

    Credibility of the acupuncture treatment is evaluated using a credibility test by Vincent et al. It is a 4-item self report on a 6-point Likert scale; its score ranges from 4 to 24 point; higher score indicates more credibility over acupuncture.

  2. Acupuncture Belief Scale (ABS)

    Time frame: day 0

    A Korean version of Acupuncture Belief Scale (ABS), a 36-item self-report on a 5-point Likert scale will be used to evaluate acupuncture experiences and beliefs. Its score ranges from 36 to 180 and higher score is considered more positive attitude toward acupuncture.

  3. State-Trait Anxiety Inventory-X (STAI-X)

    Time frame: day 0

    A Korean version of State-Trait Anxiety Inventory-X (STAI-X); each item of anxiety has its own 20 different questions on a 4-point Likert scale. The score ranges from 20 to 80, with higher score correlating with greater anxiety.

Sponsors and collaborators

Lead sponsor

Kyunghee University

Other

Collaborators

  • University of California, Davis

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 2, 2019
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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