Clinical Reporting to Alleviate the Nocebo Effect

Not Applicable

Active, not recruiting

• Conditions: Nocebo Effect
• Interventions: Diagnostic Test: Lumbar Magnetic Resonance Imaging (MRI)

• Registration Number: NCT06103474
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-26
• Study Start: 2024-01-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-14
• Primary Completion: 2027-02-20
• Study Completion: 2027-02-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care Report	Lumbar Magnetic Resonance Imaging (MRI)	The subject will receive standard of care imaging report.
Clinical Report	Lumbar Magnetic Resonance Imaging (MRI)	The subject will receive a technical report that avoids language that may cause catastrophizing or evoke the nocebo effect.

Primary Outcome Measures

Name	Time	Method
Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort.	within 7 days post intervention

Secondary Outcome Measures

Name	Time	Method
Improvement in pain interference measured via brief pain inventory	6 weeks post intervention

Trial Locations

Locations (1)

UAB; 🇺🇸 Birmingham, Alabama, United States