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Magnetic Resonance Imaging and Acute Low Back Pain

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ClinicalTrials.gov Identifier: NCT06022484
Recruitment Status : Completed
First Posted : September 5, 2023
Last Update Posted : February 6, 2024
Sponsor:
Information provided by (Responsible Party):
International Institute of Behavioral Medicines

Study Description
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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.

Condition or disease Intervention/treatment
Acute Low Back Pain 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 Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: How Many Days Will You Delay Before a MRI When You Have Low Back Pain?
Actual Study Start Date : September 15, 2023
Actual Primary Completion Date : December 31, 2023
Actual Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06022484


Locations
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Italy
Barbara Rocca
Calosso, Italy
Sponsors and Collaborators
International Institute of Behavioral Medicines
More Information
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Responsible Party: International Institute of Behavioral Medicines
ClinicalTrials.gov Identifier: NCT06022484    
Other Study ID Numbers: 2023-005
First Posted: September 5, 2023    Key Record Dates
Last Update Posted: February 6, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Institute of Behavioral Medicines:
Low back pain
Magnetic Resonance Imaging
Catastrophizing
Anxiety
Red flags
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations