Magnetic Resonance Imaging and Acute Low Back Pain

Sponsor
International Institute of Behavioral Medicines (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06022484
Collaborator
(none)
100
3.5

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational
Anticipated 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?
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Two questions on limit of tolerance [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 [Up to the first day]

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

  2. PCS [Up to the first day]

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

  3. ZUNG [Up to the first day]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • International Institute of Behavioral Medicines

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
International Institute of Behavioral Medicines
ClinicalTrials.gov Identifier:
NCT06022484
Other Study ID Numbers:
  • 2023-005
First Posted:
Sep 5, 2023
Last Update Posted:
Sep 5, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2023