Clinical Reporting to Alleviate the Nocebo Effect (CRANE)

The University of Alabama at Birmingham

Status: Active, not recruiting

Conditions: Nocebo Effect

Treatments: Diagnostic Test: Lumbar Magnetic Resonance Imaging (MRI)

Study type: Interventional

Funder types: Other

Identifiers

NCT06103474

000538053 (Other Grant/Funding Number)

300010891

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Standard of Care Report

Active Comparator group

Description:

The subject will receive standard of care imaging report.

Treatment:

Diagnostic Test: Lumbar Magnetic Resonance Imaging (MRI)

Clinical Report

Active Comparator group

Description:

The subject will receive a technical report that avoids language that may cause catastrophizing or evoke the nocebo effect.

Treatment:

Diagnostic Test: Lumbar Magnetic Resonance Imaging (MRI)