Nocebo Effect
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTLumbar Magnetic Resonance Imaging (MRI)
Lumbar Magnetic Resonance Imaging (MRI)
Sponsors
University of Alabama at Birmingham
American Roentgen Ray Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Masking description
Interpreting radiologists will be blinded to survey data. The PI will be blinded to the intervention type during the review.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort. | 6 weeks post intervention |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in pain interference measured via brief pain inventory | 6 weeks post intervention |
Countries
United States
Outcome results
None listed