Clinical trial NCT06022484: Magnetic Resonance Imaging and Acute Low Back Pain
Official title: How Many Days Will You Delay Before a MRI When You Have Low Back Pain?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Low Back Pain
Keywords: Low back pain
Magnetic Resonance Imaging
Catastrophizing
Anxiety
Red flags
Lead sponsor: International Institute of Behavioral Medicines
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Two questions on limit of tolerance
timeFrame: Up to the first day
Secondary outcomes:
measure: NRS
timeFrame: Up to the first day
measure: PCS
timeFrame: Up to the first day
measure: ZUNG
timeFrame: Up to the first day
Other outcomes:
Locations:
city: Calosso
country: Italy
facility: Barbara Rocca
Study officials:
References: