条件开放标签安慰剂有助于慢性非癌性疼痛患者减少阿片类药物的使用 (ROM)

EM 是一种客观衡量依从性的方法，并作为主要干预组成部分，在此基础上讨论依从性轨迹。 EM 对照组的参与者将收到旨在培养积极期望的基于证据的理性，并将接受关于 EM 机制的指导。

EM 对照组在结构上与 OLP 组相同，涉及参与者与研究团队成员之间接触的次数和持续时间以及干预的形式和互动的质量。

In the EM control group, the focus lies on the electronic monitoring of the opioid intake. The treatment rationale is designed to facilitate the reduction of opioid medication by promoting a positive attitude towards the implementation of the reduction. The verbal interaction follows the four discussion points:

1. The collection of EM data allows for greater patients' sense of agency over medication treatment;
2. Tracking of opioid medication use supports the reduction of opioid medication (shown by previous studies);
3. The EM is a useful tool, and daily recording of opioid medication intake should be done;
4. At a certain point, EM might provide adequate pain relief, and participants might need less opioids.

The intervention involves administering "P-Dragees blue Lichtenstein," blue placebo pills devoid of active ingredients. Each pill contains lactose monohydrate; magnesium stearate; microcrystalline cellulose; sucrose; glucose syrup; corn-starch; highly dispersed silicon dioxide; white clay; macrogol glycerol hydroxy stearate; Gum arabic; montanglycol wax; povidone; talcum; titanium dioxide; calcium carbonate; macrogol 6000; patent blue V; aluminium salt.

Participants receive an evidence-based rationale, explaining why the placebo treatment is deemed effective for pain. They are informed that the pills are placebos and are instructed to pair them with opioid medication for 7 days. After 7 days until the end of the study they are instructed to continue to pair their opioid medication with an OLP pill and take additionally placebo pills on the basis of their need. During the intervention, participants use electronic monitoring (EM) to track medication and OLP intakes.

In the intervention group, open-label placebos are administered within the framework of a mind-body management intervention approach, which in turn is consistent with the biopsychosocial model of pain and with a patient-centred approach. The verbal interaction follows the four discussion points:

1. Opioids work by telling the body that participants are not experiencing as much pain;
2. Placebos should be taken every time an opioid is taken which supports the reduction of opioid medication (shown by previous studies);
3. By pairing the pills together the brain will learn to release chemicals like endorphins that cause pain-relief in response to the placebo, just as it does in response to the opioid;
4. At a certain point, placebos might provide adequate pain relief, and the participants might need less opioids.

In addition, during the intervention, participants use electronic monitoring (EM) to track medication and OLP intakes.

在研究结束时，将使用问卷评估两个研究组（OLP 和对照组）对安慰剂的理解，该问卷评估应答者对非特异性疗法的态度。 该问卷的前三项专门评估对安慰剂的理解，并将用于本研究。 不同项目的比例不同。

量表问题1：“我从未听说过这个词”； “我以前听说过这个词，但我不知道”； “安慰剂是……（开放式问题）”量表问题 2：“对我来说，这个术语相当积极”“对我来说，这个术语是中性的，既不是积极的也不是消极的”； “对我来说这个词相当消极”； “我不知道”量表问题 3。“是的，经常”； “是的，但很少”； “不”; “我不知道”

此外，参与者还被问及在整个研究过程中他们对安慰剂的理解是否可能发生变化。 量表：“是的，积极的原因是……（开放式问题）”；是的，是否定的，因为……（开放问题）”；“否”；“我不知道”

参与者回答三个有关自上次访问研究地点以来可能出现的其他症状的问题。

问题如下：

• “自从上次来之后，你感觉怎么样？” （开放答案格式）
• “你有什么症状吗？” （是/否）
• 如果参与者在问题 2 中回答“是”，则会显示后续问题：“请详细描述您的症状。” （开放答案格式）