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Completed

NCT Number: NCT06103474

Clinical Reporting to Alleviate the Nocebo Effect

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.

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Key information

Conditions

Nocebo Effect

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar Magnetic Resonance Imaging (MRI)

Diagnostic Test

Lumbar Magnetic Resonance Imaging (MRI)

Primary outcomes

  1. Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort.

    Time frame: 6 weeks post intervention

  2. Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort.

    Time frame: within 7 days post intervention

Secondary outcomes

  1. Improvement in pain interference measured via brief pain inventory

    Time frame: 6 weeks post intervention

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • American Roentgen Ray Society

Registry information

Official study title

Clinical Reporting to Alleviate the Nocebo Effect (CRANE)

Acronym: CRANE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 26, 2023
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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