Clinical Reporting to Alleviate the Nocebo Effect (CRANE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort.
研究概览
简要总结
Terminology in radiology reports may cause patients harm by anchoring to or justifying a particular diagnosis. This phenomenon is known as the nocebo effect. MRI may cause patients to pursue more invasive procedures with little added benefit. This study aims to reproduce a study to determine the impact of clinical reporting on patient care and outcomes for those suffering from lower back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
盲法说明
Interpreting radiologists will be blinded to survey data. The PI will be blinded to the intervention type during the review.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of lower back pain undergoing MRI
- •Greater than 18 years of age
- •Able to understand and willing to comply with all study procedures and is available for the duration of the study
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in the study:
- •Acute lower back pain secondary to trauma within 1 months
- •Severe cord compression on MRI
- •Cord signal abnormality on MRI
- •Metastatic cancer
- •Spinal epidural abscess
- •Vertebral osteomyelitis
- •Judgement of the ordering physician (e.g. focal neurologic deficit)
- •Anything that, in the opinion of the investigator or team, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
研究组 & 干预措施
Standard of Care Report
The subject will receive standard of care imaging report.
干预措施: Lumbar Magnetic Resonance Imaging (MRI) (Diagnostic Test)
Clinical Report
The subject will receive a technical report that avoids language that may cause catastrophizing or evoke the nocebo effect.
干预措施: Lumbar Magnetic Resonance Imaging (MRI) (Diagnostic Test)
结局指标
主要结局
Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort.
时间窗: within 7 days post intervention
Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort.
时间窗: 6 weeks post intervention
次要结局
- Improvement in pain interference measured via brief pain inventory(6 weeks post intervention)
研究者
Steven A Rothenberg
Assistant Professor
University of Alabama at Birmingham