CRANE: Clinical Reporting to Alleviate the Nocebo Effect

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06103474
• Collaborator: American Roentgen Ray Society (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14.4
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nocebo Effect	Diagnostic Test: Lumbar Magnetic Resonance Imaging (MRI)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• 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.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.
• 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.
• Primary Purpose: Health Services Research
• Official Title: Clinical Reporting to Alleviate the Nocebo Effect (CRANE)
• Anticipated Study Start Date: Dec 11, 2023
• Anticipated Primary Completion Date: Feb 20, 2025
• Anticipated Study Completion Date: Feb 20, 2025

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort. [6 weeks post intervention]

2. Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort. [within 7 days post intervention]

Secondary Outcome Measures

1. Improvement in pain interference measured via brief pain inventory [6 weeks post intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham
• American Roentgen Ray Society

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steven A Rothenberg, Assistant Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT06103474
• Other Study ID Numbers: 300010891; 000538053
• First Posted: Oct 26, 2023
• Last Update Posted: Oct 26, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Oct 26, 2023