Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000147684
Ethics application status
Approved
Date submitted
29/01/2014
Date registered
5/02/2014
Date last updated
5/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Longitudinal Imaging of Lumbar Patients and Controls
Scientific title
MRI Longitudinal imaging for acute lumbar pain
Secondary ID [1] 283805 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
LILAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Lumbar Pain 290781 0
Condition category
Condition code
Musculoskeletal 291148 291148 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants with acute lumbar pain will be observed. We will recruit participants within 2 weeks of the onset of pain and perform the initial MRI scan within 3 weeks of pain onset. We will use MRI scanning to observe any possible changes that occur over 12 weeks. We will aim to scan participants at Week 1, Week 2, Week 6 and Week 12 from initial baseline scan.
Intervention code [1] 288490 0
Not applicable
Comparator / control treatment
10 control participants will be included in this study. These participants will have no current lumbar pain and a maximum of two previous episodes of low back pain. These control participants will be scanned at Week 1, Week 2, Week 6 and Week 12 from initial baseline scan.
Control group
Active

Outcomes
Primary outcome [1] 291136 0
Change in MRI findings
Timepoint [1] 291136 0
12 weeks
Primary outcome [2] 291415 0
Change in pain (NPRS)
Timepoint [2] 291415 0
12 weeks
Secondary outcome [1] 306099 0
Cross-sectional comparison of physical examination findings and MRI findings at baseline.
Timepoint [1] 306099 0
Day 1 - physical assessment and baseline MRI performed sequentially on the same day.

Eligibility
Key inclusion criteria
For case participants:
1. Present to a primary care practitioner with recent onset low back pain of less than 2 weeks duration
2. To be available to enrol in study and have initial MRI scan within 3 weeks from onset of pain episode
3. Current pain intensity greater than or equal to 5 on numerical pain rating scale (0-10 scale)
4. The current episode of low back pain started suddenly (pain intensity increased by at least 5 points on NPRS over a period of less than 24 hours)
5. Age less than 50 years of age
For control participants:
1. No current low back pain
2. A maximum of two previous low back episodes.
Minimum age
15 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Nerve root compromise, previous spinal surgery, canal stenosis, fracture, cancer, inflammatory joint diseases, infection, or “cauda equina” syndrome
2. Inadequate English language or cognitive abilities to complete outcome measures
3. Contraindication to MRI.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis
This is a pilot study so the numbers of participants has been pre-determined to be small.
The following brief analysis plan is as follows:
1. Longitudinal analysis to investigate and allow comparison of changes in MRI findings between cases and controls
2. Analyse the ability of changes in MRI findings to predict changes in low back pain symptoms
3. Cross-sectional analysis to assess the relationship between baseline MRI findings and clinical examination.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288463 0
Government body
Name [1] 288463 0
Arthritis NSW
Country [1] 288463 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University, NSW 2109
Country
Australia
Secondary sponsor category [1] 287166 0
None
Name [1] 287166 0
Address [1] 287166 0
Country [1] 287166 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290332 0
Human Research Ethics Committee (Medical Sciences)
Ethics committee address [1] 290332 0
Research Office
C5C Research HUB East, Level 3, Room 324
Macquarie University NSW 2109
Ethics committee country [1] 290332 0
Australia
Date submitted for ethics approval [1] 290332 0
Approval date [1] 290332 0
27/11/2013
Ethics approval number [1] 290332 0
5201300630

Summary
Brief summary
Back pain is very common, and the leading cause of disability in Australia. The relationship between MRI findings and symptoms in people with LBP remains unclear. There are very few high quality research papers investigating the relationship between MRI findings and low back pain. Very few studies have performed repeated MRIs and in these studies scans have been separated by long periods of time. Almost nothing is known about the changes in MRI findings in the first 6 weeks after an episode of low back pain despite this being the critical time period when most changes in clinical symptoms occur. To investigate the potential importance of MRI findings as a source of low back pain, it is essential to track these findings closely during an episode of low back pain and investigate the relationship between changes in MRI and changes in patient’s symptoms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45122 0
Dr Mark Hancock
Address 45122 0
Department of Health Professions
Macquarie University
NSW 2109
Country 45122 0
Australia
Phone 45122 0
+61 2 9850 6622
Fax 45122 0
+61 2 9850 8062
Email 45122 0
[email protected]
Contact person for public queries
Name 45123 0
Dr Mark Hancock
Address 45123 0
Department of Health Professions
Macquarie University
NSW 2109
Country 45123 0
Australia
Phone 45123 0
+61 2 98506622
Fax 45123 0
+61 2 9850 8062
Email 45123 0
[email protected]
Contact person for scientific queries
Name 45124 0
Dr Mark Hancock
Address 45124 0
Department of Health Professions
Macquarie University
NSW 2109
Country 45124 0
Australia
Phone 45124 0
+61 2 98506622
Fax 45124 0
+61 2 9850 8062
Email 45124 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.