Boosting Open-Label Placebo Effects in Acute Induced Pain in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Part 2: Change in Area under the Pain Curve (AUPC)
研究概览
简要总结
This study is to investigate the effect of open-label placebo (OLP) application on acute pain in an experimental model of acute pain (simulating wound pain: this installation will apply monophasic, rectangular electrical pulses of 0.5ms duration with alternating polarity at 2 Hz frequency. The current will be increased to target a pain rating of 6 of 10 on the NRS (0 = no pain, 10 = worst imaginable pain). Three further adjustments in current will be made every 5 minutes for the next 15 minutes to compensate for habituation. This final current will be kept constant until the end of the particular experiment).
In Part 1 duration of OLP analgesia will be examined, and onset and size of the effect will be reevaluated.
In Part 2 of this study outcomes between subjects receiving one OLP injection, subjects receiving one repetition of the injection on a fixed time point and subjects receiving one repetition of the injection on-demand will be evaluated
详细描述
Pain is highly prevalent in hospital settings. Standard systemic treatment for acute pain consists mainly of basic analgesia. The use of these drugs is often restricted due to their contraindications. Placebo is used nowadays to describe sham treatments and "inert" substances like sugar pills and saline injections. Placebos are proven to elicit clinically significant effects in various conditions, including pain. Ethical concerns about the use of deceptive placebos have prevented their implementation in clinical practice. A possibility to address this issue would be to prescribe placebos openly, that means, without deception. This randomized crossover study evaluates the efficacy of open-label placebo (OLP) in acute pain. Subjective pain ratings and areas of hyperalgesia and allodynia will be measured in a well-established experimental pain model (intradermal electrical stimulation model evoking pain: this installation will apply monophasic, rectangular electrical pulses of 0.5ms duration with alternating polarity at 2 Hz frequency. The current will be increased to target a pain rating of 6 of 10 on the NRS (0 = no pain, 10 = worst imaginable pain). Three further adjustments in current will be made every 5 minutes for the next 15 minutes to compensate for habituation. This final current will be kept constant until the end of the particular experiment) and analgesia elicited by OLP injections will be investigated.
In Part 1 duration of OLP analgesia will be examined, and onset and size of the effect will be reevaluated.
In Part 2 of this study outcomes between subjects receiving one OLP injection, subjects receiving one repetition of the injection on a fixed time point and subjects receiving one repetition of the injection on-demand will be evaluated (which leaves the last group a choice over when they would like to have the placebo "booster").
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
In part 1 the assessor won't know whether subjects receive the study intervention or not (single-blinded).
Due to organizational reasons, blinding of the assessor will not be possible in Part 2.
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
- •Healthy volunteers (ASA Class I or II), aged 18 to 65 years
- •BMI between 18 and 25kg/m2
- •Able to understand the study and the NRS
- •Able to give informed consent
排除标准
- •Participation in a previous open-label placebo study; for Part 2, this includes Part 1 of this study
- •Regular intake of medications or drugs potentially interfering with pain sensation (analgesics, opioids, antihistamines, calcium and potassium channel blockers, serotonin/ noradrenaline reuptake inhibitors, corticosteroids)
- •Neuropathy
- •Chronic pain
- •Neuromuscular disease
- •Dermatological disease (i.e. Atopic Dermatitis)
- •Psychiatric disease
- •Pregnancy / Lactation
结局指标
主要结局
Part 2: Change in Area under the Pain Curve (AUPC)
时间窗: During three hours after administering an OLP
Area under the Pain Curve (AUPC) using the numeric rating scale (NRS; 0 = no pain, 10 = worst imaginable pain). Comparison of the AUPCs of subjects receiving just one OLP injection with subjects additionally receiving one repetition of OLP administration at a time point derived from Part 1 and subjects getting the second OLP injection on-demand.
Part 1: Change in Area under the Pain Curve (AUPC)
时间窗: During three hours after administering an OLP
Area under the Pain Curve (AUPC) using the numeric rating scale (NRS; 0 = no pain, 10 = worst imaginable pain) during three hours after administering an OLP
次要结局
- Part 1 and 2: Change in Area under the Curve (AUC) of area of hyperalgesia(Up to 200 minutes after electrical pain stimulation)
- Part 1 and 2: Change in subjective pain ratings on each measurement point using the numeric rating scale (NRS)(Up to 200 minutes after electrical pain stimulation)
- Part 1 and 2: Change in Area under the Curve (AUC) of area of allodynia(Up to 200 minutes after electrical pain stimulation)