Acute Low Back PainNCT06022484
Magnetic Resonance Imaging and Acute Low Back Pain
An observational study of Acute Low Back Pain, run by International Institute of Behavioral Medicines at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Low Back Pain
- What is being tested?
- The present study does not contain any intervention
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Having acute low back pain (i.e., a pain lasting no more than 6 weeks)
- Adult age
- Ability to understand the Italian language
Who cannot join
- Mental deficits
- Refuse to adhere to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Many Days Will You Delay Before a MRI When You Have 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.
Read the 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.
- Conditions
- Acute Low Back Pain
- Being tested
- The present study does not contain any intervention
- Keywords
- Low back pain, Magnetic Resonance Imaging, Catastrophizing, Anxiety, Red flags
- Medical subject headings
- Low Back Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The present study does not contain any interventionOther
The present study does not contain any intervention
| Study group | Role | What they receive |
|---|---|---|
| People with acute low back pain | No intervention. Receives: Other: The present study does not contain any intervention | |
| General practitioners who treat people with acute low back pain | No intervention. Receives: Other: The present study does not contain any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to the first day
Secondary outcomes (3)
NRS
pain intensity Numerical Rating Scale; score 0-10 with higher estimates indicating higher levels of pain intensity
Measured: Up to the first day
PCS
Pain Catastrophizing Scale; score 0-52 with higher estimates indicating higher levels of catastrophizing.
Measured: Up to the first day
ZUNG
Zung Self-Rating Anxiety Scale; score 20-80 with higher estimates indicating higher levels of anxiety
Measured: Up to the first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start15 Sep 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Institute of Behavioral Medicines
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022484
- Sponsor's protocol ID
- 2023-005
- Status last verified
- Feb 2024
- First submitted
- 21 Aug 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Many Days Will You Delay Before a MRI When You Have Low Back Pain?
- ClinicalTrials.gov ID
- NCT06022484
- Acronym / sponsor ID
- 2023-005
- Conditions
- Acute Low Back Pain
- Keywords
- Low back pain, Magnetic Resonance Imaging, Catastrophizing, Anxiety, Red flags
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- International Institute of Behavioral MedicinesUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with acute low back pain | – | Other: The present study does not contain any interventionNo intervention. |
| General practitioners who treat people with acute low back pain | – | Other: The present study does not contain any interventionNo intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Having acute low back pain (i.e., a pain lasting no more than 6 weeks)
- Adult age
- Ability to understand the Italian language
Key exclusion criteria (2 listed)
- Mental deficits
- Refuse to adhere to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The present study does not contain any interventionThe present study does not contain any intervention | Other | General practitioners who treat people with acute low back pain, People with acute low back pain |
Primary outcome
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).
3 secondary outcomes
NRS
Time frame: Up to the first day
PCS
Time frame: Up to the first day
ZUNG
Time frame: Up to the first day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Low Back Pain, run by International Institute of Behavioral Medicines at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two questions on limit of tolerance (time frame: Up to the first day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.