Clinical Reporting to Alleviate the Nocebo Effect

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Reporting to Alleviate the Nocebo Effect (CRANE)

Conditions
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Nocebo Effect

Intervention / Treatment
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* Diagnostic Test: Lumbar Magnetic Resonance Imaging (MRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Survey, cross-sectional study of sixty (n=60) participants undergoing MRI for lower back pain will be randomized to receive an anatomic report (standard of care) versus a Clinical Report (CR). Ordering physicians receiving the Clinical Reports will be instructed to avoid terms that may result in cyberchondria or fear (e.g. disc bulge or nerve impingement) when discussing MRI results.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care Report<br>The subject will receive standard of care imaging report. | Diagnostic Test: Lumbar Magnetic Resonance Imaging (MRI)<br>* Lumbar Magnetic Resonance Imaging (MRI)<br>|
| Active Comparator: Clinical Report<br>The subject will receive a technical report that avoids language that may cause catastrophizing or evoke the nocebo effect. | Diagnostic Test: Lumbar Magnetic Resonance Imaging (MRI)<br>* Lumbar Magnetic Resonance Imaging (MRI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort. |  | 6 weeks post intervention | 
| Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort. |  | within 7 days post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in pain interference measured via brief pain inventory |  | 6 weeks post intervention |