Magnetic Resonance Imaging and Acute Low Back Pain

How Many Days Will You Delay Before a MRI When You Have Low Back Pain?

This is a behavioral observational study aimed at understanding the limit of tolerance (in days) of ideally performing a Magnetic Resonance Imaging (MRI) by people with acute low back pain. It consists of a short self-administered questionnaire. Relationships between low back pain intensity, maladaptive thoughts and awaited days before ideally requesting a MRI will be evaluated.

Study Overview

• Status: Completed
• Conditions: Acute Low Back Pain
• Intervention / Treatment: Other: The present study does not contain any intervention

Detailed Description

This is a behavioral observational study aimed at understanding the limit of tolerance (in days) of ideally performing a Magnetic Resonance Imaging (MRI) by people with acute low back pain (LBP) and by general practitioners (GP).

Literature pointed out that LBP is a common occurrence in people, with high rates of self-resolution in the absence of red flags (i.e. possible indicators of serious spinal pathology).

In Italy there is an over-prescription of MRI despite international guidelines go the opposite way.

The study consists of a short self-administered questionnaire which will be given to people and GP to complete. In more details, the survey is made of 3 questions collecting information on the limit of tolerance (in days) before requesting (people) and prescribing (GP) a MRI for the lumbar tract of the spinal column.

Further, participants will have to complete a self-administered pain intensity numerical rating scale, along with catastrophizing and anxiety self-administered questionnaires.

Descriptive statistics will be presented by taking into account the socio-demographic characteristics of the sample being investigated. Statistical correlations between participants' answers and the scores from the questionnaires will be also evaluated.

This study investigates the relationships among acute low back pain, the intention of persons/GP to request/prescribe a MRI despite the absence of red flags, mood disorders and maladaptive thoughts.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Italy
  • Calosso, Italy
    • Barbara Rocca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult people with acute low back pain (i.e., a pain lasting no more than 6 weeks).

General practitioners who are involved in the managment of people with acute low back pain.

Description

Inclusion Criteria:

• Having acute low back pain (i.e., a pain lasting no more than 6 weeks)
• Adult age
• Ability to understand the Italian language

Exclusion Criteria:

• Mental deficits
• Refuse to adhere to the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
People with acute low back pain; No intervention.	Other: The present study does not contain any intervention; The present study does not contain any intervention
General practitioners who treat people with acute low back pain; No intervention.	Other: The present study does not contain any intervention; The present study does not contain any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Two questions on limit of tolerance	Design of questions which investigates the limit of tolerance of requesting and prescribing a MRI; score is expressed as "number of days" (neither min nor max values are stated a priori).	Up to the first day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS	pain intensity Numerical Rating Scale; score 0-10 with higher estimates indicating higher levels of pain intensity	Up to the first day
PCS	Pain Catastrophizing Scale; score 0-52 with higher estimates indicating higher levels of catastrophizing.	Up to the first day
ZUNG	Zung Self-Rating Anxiety Scale; score 20-80 with higher estimates indicating higher levels of anxiety	Up to the first day

Collaborators and Investigators

• Sponsor: International Institute of Behavioral Medicines

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; Low back pain; Magnetic Resonance Imaging; Catastrophizing; Red flags
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2023-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No