Effect of Information on Placebo in the Informed Consent on the Trial Outcomes and Participant Blinding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- the change in muscle discomfort from baseline, i.e., immediately after being induced DOMS, measured by visual analogue scale (VAS)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age over 18
- •not participating in other studies at the time of study participation
- •voluntary participation
排除标准
- •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
研究组 & 干预措施
real acupuncture-full disclosure
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).
干预措施: acupuncture (Device)
real acupuncture-partial disclosure
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).
干预措施: acupuncture (Device)
sham acupuncture-full disclosure
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).
干预措施: Park Sham Needle (Device)
sham acupuncture-partial disclosure
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).
干预措施: Park Sham Needle (Device)
结局指标
主要结局
the change in muscle discomfort from baseline, i.e., immediately after being induced DOMS, measured by visual analogue scale (VAS)
时间窗: 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.)
Blinding property
时间窗: 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.
the change in Pressure Pain Threshold (PPT) from baseline, i.e., before being induced DOMS
时间窗: 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.
次要结局
- Acupuncture sensation measured by De-qi questionnaire(day 0; day 1; day 2)
研究者
Hyangsook Lee, KMD, PhD
Professor
Kyunghee University