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MRI Reporting for Lower Back Pain (CRANE Trial)

N/A

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Greater than 18 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 7 days post intervention

Awards & highlights

CRANE Trial Summary

This trial aims to determine if radiology terminology can cause more harm than good for those with lower back pain. MRI may cause people to pursue unneeded, invasive treatments.

Who is the study for?

This trial is for adults over 18 who can follow the study's procedures and are available throughout its duration. They must have a history of lower back pain and be undergoing an MRI. It's not for those with severe spinal issues, infections, cancer in the spine, recent trauma-related back pain, or any condition that might increase risk or affect participation.Check my eligibility

What is being tested?

The study investigates how wording in radiology reports (like those from lumbar MRIs) may influence patient perceptions and decisions—known as the nocebo effect—in individuals with lower back pain.See study design

What are the potential side effects?

Since this trial involves standard MRI procedures without new medications or invasive treatments, significant side effects are not expected. However, some patients may experience discomfort during the MRI.

CRANE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 18 years.

CRANE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 7 days post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 7 days post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 7 days post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improvement of the visual analog scale (VAS) pain score in Clinical Report Cohort.

Secondary outcome measures

Improvement in pain interference measured via brief pain inventory

CRANE Trial Design

2Treatment groups

Active Control

Group I: Clinical ReportActive Control1 Intervention

The subject will receive a technical report that avoids language that may cause catastrophizing or evoke the nocebo effect.

Group II: Standard of Care ReportActive Control1 Intervention

The subject will receive standard of care imaging report.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Roentgen Ray SocietyOTHER

1 Previous Clinical Trials

18 Total Patients Enrolled

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,602 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollments still being accepted for the trial?

"According to the clinicaltrials.gov website, this medical trial is not currently in search of participants. Initially published on December 11th 2023 and last updated October 25th 2023, there are however 1 other trials actively enrolling patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Reporting to Alleviate the Nocebo Effect

Steven A Rothenberg 2024. "Clinical Reporting to Alleviate the Nocebo Effect". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06103474.