Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000567022
Ethics application status
Approved
Date submitted
31/05/2010
Date registered
13/07/2010
Date last updated
15/06/2021
Date data sharing statement initially provided
15/06/2021
Date results information initially provided
15/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring the clinical validity of the nerve root sedimentation sign in magnetic resonance imaging for the diagnosis of lumbar spinal stenosis
Scientific title
In patients with suspected lumbar spinal stenosis (LSS), does the nerve root sedimentation sign in magnetic resonance imaging (MRI), compared with the existing diagnostic tests, improve the detection of clinically relevant LSS and improve patient outcomes?
Secondary ID [1] 251904 0
nil
Universal Trial Number (UTN)
U1111-1115-3986
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lumbar spinal stenosis 257493 0
Condition category
Condition code
Musculoskeletal 257647 257647 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Lumbar spinal stenosis is a common degenerative disorder of the spine in elderly patients that can be effectively treated with decompression surgery in some patients.

The recently described sedimentation sign in magnetic resonance imaging (MRI) assesses the distribution of nerve roots within the spinal canal: In supine MRI scans of patients without lumbar spinal stenosis, the lumbar nerve roots sediment to the dorsal part of the dural sac (negative sedimentation sign). In patients with severe lumbar spinal stenosis, there is no sedimentation of nerve roots (positive sedimentation sign).

In this retrospective study, the medical charts and MRI scans of patients presenting with low back pain to a spine clinic from 2004 to 2007 will be used to assess the validity of the sedimentation sign in clinical practice.

The results of the sedimentation sign will be compared with the treatment selection based on the existing tests. Patient health outcomes will be compared between sedimentation sign negative and positive findings.

Data collection and sedimentation sign measurement will commence in August 2010 and take approximately 3 months.
Intervention code [1] 256587 0
Not applicable
Comparator / control treatment
Data collected from medical charts (2004-2007): Existing diagnostic tests, including patient history, clinical examination, imaging tests (MRI), and treadmill test.

All patients received all tests, and the treatment administered (decompression surgery vs conservative treatment) was based on the results of the existing tests.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258553 0
Data derived from the medical charts: Change in the Oswestry Disability Index (ODI) for outcome assessment of spinal disorders.

The change in ODI will be used to compare sedimentation sign positives vs negatives in patients treated for LSS (decompression surgery) or non-specific low back pain (no decompression surgery).
Timepoint [1] 258553 0
Data collected in Aug-Dec 2010, derived from medical charts from 2004-2007: ODI recorded in medical charts at baseline and in follow-up examinations at 24 months after treatment.
Secondary outcome [1] 264398 0
Data derived from the medical charts: Change in Visual Analogue Scale (VAS) for pain assessment.

VAS will be used to compare sedimentation sign positives vs negatives in patients treated for lumbar spinal stenosis (decompression surgery) or non-specific low back pain (no decompression surgery).
Timepoint [1] 264398 0
Data collected in Aug-Dec 2010, derived from medical charts from 2004-2007: VAS recorded in medical charts at baseline and in follow-up examinations at 24 months after treatment.
Secondary outcome [2] 264399 0
The rates of delayed decompression surgery at the same level during the follow-up interval are compared in sedimentation sign positives vs negatives in patients initially treated for non-specific low back pain (no decompression surgery).
Timepoint [2] 264399 0
Data collected in Aug-Dec 2010, derived from medical charts from 2004-2007: Operations recorded in medical charts in follow-up examinations at 24 months after initial diagnosis.
Secondary outcome [3] 264400 0
The inter-rater reliability of the sedimentation sign ratings between the two investigators will be calculated.
Timepoint [3] 264400 0
Jan-Mar 2011, during the measurement of the sedimentation sign in magnetic resonance imaging scans of the patients from 2004-2007.

Eligibility
Key inclusion criteria
Patients who presented between January 2004 and December 2007 and in whom lumbar spinal stenosis was suspected based on patient history and clinical examination: History of neurogenic intermittent claudication, Treadmill test performed, VAS and ODI scores pre- and postoperative available
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No MRI available; Contraindication for surgery; Acute spine disease (disc herniation, inflammation); Primary or metastatic malignant disease in the spine; Previous spine surgery; History of inflammatory disease of the spine; Musculoskeletal impairments compromising ability to walk (severe coxarthrosis/gonarthrosis); Peripheral arterial disease (Fontaine stage 2b and higher); Polyneuropathy;
LSS level L5/S1; Specific low back pain other than due to LSS

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2010
Actual
1/08/2010
Date of last participant enrolment
Anticipated
Actual
1/08/2010
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
220
Accrual to date
Final
175
Recruitment outside Australia
Country [1] 2675 0
Germany
State/province [1] 2675 0

Funding & Sponsors
Funding source category [1] 257081 0
Self funded/Unfunded
Name [1] 257081 0
Country [1] 257081 0
Primary sponsor type
Individual
Name
Thomas Barz
Address
Asklepios Klinikum Uckermark
Auguststrasse 23
160303 Schwedt/Oder
Country
Germany
Secondary sponsor category [1] 256340 0
Individual
Name [1] 256340 0
Lukas P Staub
Address [1] 256340 0
The National Health and Medical Research Council (NHMRC) Clinical Trials Centre
The University of Sydney
Locked Bag 77
Camperdown NSW 1450
Country [1] 256340 0
Australia
Other collaborator category [1] 251383 0
Individual
Name [1] 251383 0
Markus Melloh
Address [1] 251383 0
Section of Orthopaedic Surgery
Department of Medical and Surgical Sciences
Dunedin School of Medicine
University of Otago
Private Bag 1921
Dunedin 9054
Country [1] 251383 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259105 0
Ethics Board of the Asklepios Klinikum Schwedt, Germany
Ethics committee address [1] 259105 0
Asklepios Klinikum Uckermark
Auguststrasse 23
160303 Schwedt/Oder
Ethics committee country [1] 259105 0
Germany
Date submitted for ethics approval [1] 259105 0
Approval date [1] 259105 0
30/06/2010
Ethics approval number [1] 259105 0
003 / 2010

Summary
Brief summary
Background: Lumbar spinal stenosis is a common degenerative disorder of the spine in elderly patients that can be effectively treated with decompression surgery. Patient history, clinical examination and imaging tests are used for diagnosis. Radiological findings in the diagnostic work-up of the patients do not always correlate well with clinical symptoms, and guidance about when to proceed to surgery is inconsistent.

The recently described nerve root sedimentation sign in magnetic resonance scans is proposed to detect clinically relevant stenosis. It has been shown to discriminate well between selected patients with and without lumbar spinal stenosis but the performance of this new test, when used in a broad patient population, is not yet known. There is no accepted reference standard for the diagnosis of lumbar spinal stenosis.

Methods/Design: The aim of this study is to assess the clinical validity of the sedimentation sign by evaluating its association with patient outcomes in patients with suspected lumbar spinal stenosis, and to define the role of the sedimentation sign in clinical practice. It is a single-centre retrospective chart review of patients referred to an orthopaedic spine unit for the investigation of suspected lumbar spinal stenosis.

The sedimentation sign will be cross-classified with decisions for surgery based on existing tests and patient outcomes in 24 month follow-up examinations. The results will be used to estimate: i) how well the sedimentation sign can distinguish between patients that do or do not benefit from surgery, and ii) the concordance between the sedimentation sign and existing tests to explore its possible value as a triage test. In addition, the agreement in sedimentation sign ratings of two observers will be measured.

Discussion: In the absence of a reference standard, the study design presented here will provide data to estimate the potential impact of the sedimentation sign on patient outcomes. The observed proportion of discordant test results will help inform the design of future randomised trials of the sedimentation sign.
Trial website
Trial related presentations / publications
Barz T, Melloh M, Staub LP, Lord SJ, Lange J, Röder CP, Theis JC, Merk HR. Nerve root sedimentation sign: evaluation of a new radiological sign in lumbar spinal stenosis. Spine 2010 Apr 15;35(8):892-7.
Public notes

Contacts
Principal investigator
Name 31243 0
Dr Thomas Barz
Address 31243 0
Department of Orthopaedic Surgery, Asklepios Klinikum Uckermark, Auguststraße 23, 16303 Schwedt/Oder, Germany
Country 31243 0
Germany
Phone 31243 0
+4907977602885
Fax 31243 0
Email 31243 0
thomasbarz@schwed.de
Contact person for public queries
Name 14490 0
Dr Thomas Barz
Address 14490 0
Department of Orthopaedic Surgery
Auguststrasse 23
16303 Asklepios Klinikum Uckermark
Schwedt/Oder
Country 14490 0
Germany
Phone 14490 0
+49 33 32 532314
Fax 14490 0
+49 33 32 532735
Email 14490 0
barz@swschwedt.de
Contact person for scientific queries
Name 5418 0
Dr Lukas P Staub
Address 5418 0
NHMRC Clinical Trials Centre
The University of Sydney
Locked Bag 77
Camperdown NSW 1450
Country 5418 0
Australia
Phone 5418 0
+61 2 9562 5088
Fax 5418 0
Email 5418 0
lukas.staub@ctc.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Thomas Barz, Lukas P Staub, Markus Melloh, Gregor ... [More Details]

Documents added automatically
No additional documents have been identified.