Magnetic Resonance Imaging and Acute Low Back Pain

Acute Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06022484
• Other study ID #: 2023-005
• Status: Completed
• Start date: September 15, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: International Institute of Behavioral Medicines
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Low Back Pain
• Back Pain
• Low Back Pain

Intervention

Other:
• The present study does not contain any intervention
The present study does not contain any intervention

Locations

Country	Name	City	State
Italy	Barbara Rocca	Calosso

Sponsors (1)

Lead Sponsor	Collaborator
International Institute of Behavioral Medicines

Country where clinical trial is conducted

Italy, 

Outcome

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