Clinical Reporting to Alleviate the Nocebo Effect (CRANE)

Clinical Reporting to Alleviate the Nocebo Effect (CRANE)

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.

Study Overview

• Status: Completed
• Conditions: Nocebo Effect
• Intervention / Treatment: Diagnostic test: Lumbar Magnetic Resonance Imaging (MRI)

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: American Roentgen Ray Society

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2024
• Primary Completion (Actual): November 11, 2025
• Study Completion (Actual): November 11, 2025

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 300010891; American Roentgen Ray Society (Other Grant/Funding Number: American Roentgen Ray Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No