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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 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]

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

Condition category

Condition code

Musculoskeletal

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]

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]

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]

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]

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]

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]

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]

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]

The inter-rater reliability of the sedimentation sign ratings between the two investigators will be calculated.

Timepoint [3]

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?

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]

Germany

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Thomas Barz

Address

Asklepios Klinikum Uckermark
Auguststrasse 23
160303 Schwedt/Oder

Country

Germany

Secondary sponsor category [1]

Individual

Name [1]

Lukas P Staub

Address [1]

The National Health and Medical Research Council (NHMRC) Clinical Trials Centre
The University of Sydney
Locked Bag 77
Camperdown NSW 1450

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Markus Melloh

Address [1]

Section of Orthopaedic Surgery
Department of Medical and Surgical Sciences
Dunedin School of Medicine
University of Otago
Private Bag 1921
Dunedin 9054

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Board of the Asklepios Klinikum Schwedt, Germany

Ethics committee address [1]

Asklepios Klinikum Uckermark 
Auguststrasse 23
160303 Schwedt/Oder

Ethics committee country [1]

Germany

Date submitted for ethics approval [1]

Approval date [1]

30/06/2010

Ethics approval number [1]

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

Dr Thomas Barz

Address

Department of Orthopaedic Surgery, Asklepios Klinikum Uckermark, Auguststraße 23, 16303 Schwedt/Oder, Germany

Country

Germany

Phone

+4907977602885

Fax

thomasbarz@schwed.de

Contact person for public queries

Name

Thomas Barz

Address

Department of Orthopaedic Surgery
Auguststrasse 23
16303 Asklepios Klinikum Uckermark
Schwedt/Oder

Country

Germany

Phone

+49 33 32 532314

Fax

+49 33 32 532735

barz@swschwedt.de

Contact person for scientific queries

Name

Lukas P Staub

Address

NHMRC Clinical Trials Centre
The University of Sydney
Locked Bag 77
Camperdown NSW 1450

Country

Australia

Phone

+61 2 9562 5088

Fax

lukas.staub@ctc.usyd.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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