Magnetic Resonance Imaging and Acute Low Back Pain
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06022484 |
|
Recruitment Status :
Completed
First Posted : September 5, 2023
Last Update Posted : February 6, 2024
|
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | August 21, 2023 | ||||
| First Posted Date | September 5, 2023 | ||||
| Last Update Posted Date | February 6, 2024 | ||||
| Actual Study Start Date | September 15, 2023 | ||||
| Actual Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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).
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Magnetic Resonance Imaging and Acute Low Back Pain | ||||
| Official Title | How Many Days Will You Delay Before a MRI When You Have Low Back Pain? | ||||
| 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. | ||||
| 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 Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
||||
| Condition | Acute Low Back Pain | ||||
| Intervention | Other: The present study does not contain any intervention
The present study does not contain any intervention
|
||||
| Study Groups/Cohorts |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
100 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Actual Study Completion Date | December 31, 2023 | ||||
| Actual Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 18 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Italy | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT06022484 | ||||
| Other Study ID Numbers | 2023-005 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement |
|
||||
| Current Responsible Party | International Institute of Behavioral Medicines | ||||
| Original Responsible Party | Same as current | ||||
| Current Study Sponsor | International Institute of Behavioral Medicines | ||||
| Original Study Sponsor | Same as current | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | International Institute of Behavioral Medicines | ||||
| Verification Date | February 2024 | ||||