NCT06022484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

August 21, 2023

Last Update Submit

February 5, 2024

Conditions

Acute Low Back Pain

Keywords

Low back painMagnetic Resonance ImagingCatastrophizingAnxietyRed flags

Outcome Measures

Primary Outcomes (1)

  • Two questions on limit of tolerance

    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).

    Up to the first day

Secondary Outcomes (3)

  • NRS

    Up to the first day

  • PCS

    Up to the first day

  • ZUNG

    Up to the first day

Study Arms (2)

People with acute low back pain

No intervention.

Other: 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

Interventions

The present study does not contain any interventionOTHER

The present study does not contain any intervention

General practitioners who treat people with acute low back painPeople with acute low back pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Having acute low back pain (i.e., a pain lasting no more than 6 weeks)
  • Adult age
  • Ability to understand the Italian language

You may not qualify if:

  • Mental deficits
  • Refuse to adhere to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Rocca

Calosso, Italy

Location

MeSH Terms

Conditions

Low Back PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

September 5, 2023

Study Start

September 15, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)