Clinical Reporting to Alleviate the Nocebo Effect

NCT06103474 | Completed FDA Device

• 2 other identifiers: 300010891000538053
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Nocebo Effect

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Improvement in pain interference measured via brief pain inventory

  6 weeks post intervention

Study Arms (2)

Standard of Care Report

ACTIVE COMPARATOR

The subject will receive standard of care imaging report.

Diagnostic Test: Lumbar Magnetic Resonance Imaging (MRI)

Clinical Report

ACTIVE COMPARATOR

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)

Interventions

Lumbar Magnetic Resonance Imaging (MRI) DIAGNOSTIC_TEST

Lumbar Magnetic Resonance Imaging (MRI)

Clinical Report; Standard of Care Report

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• American Roentgen Ray Society: collaborator

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Interpreting radiologists will be blinded to survey data. The PI will be blinded to the intervention type during the review.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 26, 2023
• Study Start: January 14, 2024
• Primary Completion: November 11, 2025
• Study Completion: November 11, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)