Magnetic Resonance Imaging and Acute Low Back Pain

NCT ID: NCT06022484

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-15

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Acute Low Back Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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People with acute low back pain

No intervention.

The present study does not contain any intervention

Intervention Type OTHER

The present study does not contain any intervention

General practitioners who treat people with acute low back pain

No intervention.

The present study does not contain any intervention

Intervention Type OTHER

The present study does not contain any intervention

Interventions

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The present study does not contain any intervention

The present study does not contain any intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Institute of Behavioral Medicines

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Barbara Rocca

Calosso, , Italy

Site Status

Countries

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Italy

Other Identifiers

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2023-005

Identifier Type: -

Identifier Source: org_study_id

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