Optimizing Open Placebos for Chronic Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 327
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
The goal of this clinical trial is to examine the effect of rationale condition when taking open-label placebos on pain by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other. We also aim to examine the effect of rationale condition on prescription opioid use by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other.
This study will include patients with chronic low back pain. The main question it aims to answer is:
How do rationales influence the effects of open-label placebos?
Researchers will compare different rationales given when taking an open-label placebo and a no-treatment group and a no rationale group taking OLPs.
详细描述
Further information about study design and hypothesis is provided in the following citation. Study start date refers to the date the first participant completed baseline assessment.
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
- None
盲法说明
Participants are blind to the research hypothesis but not to treatment allocation that are by definition open.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic pain (pain lasting at least 3 months, pain intensity 4/10 or over and interference 3/10 or over)
- •at least 18 years old
- •English speaking
- •have a smartphone or computer with video access
- •the chronic pain is concentrated into the patient's lower back (tentative criteria based on recruitment rate)
排除标准
- •Have chronic pain because of a cancer diagnosis
- •Over 89 years of age
- •Suspect an allergy to any placebo ingredient
- •Currently receiving worker's compensation.
研究组 & 干预措施
No Treatment + Control Rationale
Participants in this group will receive no treatment. They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design.
干预措施: Control Rationale (Behavioral)
OLP + Standard Rationale
Participants in this group will receive an open-label placebo along with information based on the standard rationales used in other OLP studies.
干预措施: Open-label Placebo (Drug)
OLP + Standard Rationale
Participants in this group will receive an open-label placebo along with information based on the standard rationales used in other OLP studies.
干预措施: Standard Rationale (Behavioral)
OLP + Control Rationale
Participants in this group will receive an open-label placebo along with no information on the placebo effect.. They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design.
干预措施: Control Rationale (Behavioral)
OLP + Mindfulness Rationale
Participants in this group will receive an open-label placebo along with information with mindfulness information.
干预措施: Open-label Placebo (Drug)
OLP + Mindfulness Rationale
Participants in this group will receive an open-label placebo along with information with mindfulness information.
干预措施: Mindfulness (Behavioral)
OLP + Control Rationale
Participants in this group will receive an open-label placebo along with no information on the placebo effect.. They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design.
干预措施: Open-label Placebo (Drug)
结局指标
主要结局
Pain intensity
时间窗: across 42 days
Single-item assessing current pain level from 0 (min value) to 10 (max value). Higher scores indicate more pain intensity
次要结局
- Pain interference(across 42 days)
- Pain catastrophizing(across 42 days)
- Prescription Medication use (including opioids)(across 42 days)
研究者
Michael Bernstein
Assistant Professor
Rhode Island Hospital