Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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.
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.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Standard of Care Report
The subject will receive standard of care imaging report.
  • Diagnostic Test: Lumbar Magnetic Resonance Imaging (MRI)
    Lumbar Magnetic Resonance Imaging (MRI)
Active Comparator
Clinical Report
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)
    Lumbar Magnetic Resonance Imaging (MRI)

Recruiting Locations

UAB
Birmingham, Alabama 35294
Contact:
Evan Hudson
205-934-6499
evanhudson@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Evan Hudson
2059346499
evanhudson@uabmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.