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OpenTrials
Completed

NCT Number: NCT06022484

Magnetic Resonance Imaging and Acute 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Barbara Rocca

Calosso, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The present study does not contain any intervention

Other

The present study does not contain any intervention

Primary outcomes

  1. Two questions on limit of tolerance

    Time frame: Up to the first day

    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).

Secondary outcomes

  1. NRS

    Time frame: Up to the first day

    pain intensity Numerical Rating Scale; score 0-10 with higher estimates indicating higher levels of pain intensity

  2. PCS

    Time frame: Up to the first day

    Pain Catastrophizing Scale; score 0-52 with higher estimates indicating higher levels of catastrophizing.

  3. ZUNG

    Time frame: Up to the first day

    Zung Self-Rating Anxiety Scale; score 20-80 with higher estimates indicating higher levels of anxiety

Sponsors and collaborators

Lead sponsor

International Institute of Behavioral Medicines

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2023
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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