Clinical Reporting to Alleviate the Nocebo Effect

Nocebo Effect Clinical Trial

— CRANE  

Official title:

Clinical Reporting to Alleviate the Nocebo Effect (CRANE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06103474
• Other study ID #: 300010891
• Secondary ID: 000538053
• Status: Recruiting
• Phase: N/A
• Start date: January 14, 2024
• Est. completion date: February 20, 2025

Study information

• Verified date: January 2024
• Source: University of Alabama at Birmingham
• Contact: Evan Hudson
• Phone: 2059346499
• Email: evanhudson[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 20, 2025
• Est. primary completion date: February 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nocebo Effect

Intervention

Diagnostic Test:
• Lumbar Magnetic Resonance Imaging (MRI)
Lumbar Magnetic Resonance Imaging (MRI)

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	American Roentgen Ray Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort.		6 weeks post intervention
Primary	Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort.		within 7 days post intervention
Secondary	Improvement in pain interference measured via brief pain inventory		6 weeks post intervention