Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06103474
Other study ID # 300010891
Secondary ID 000538053
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04766580 - Attention and Pain in Children With and Without Attention Deficit and/or Hyperactivity Disorder N/A