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Trial registered on ANZCTR

Registration number

ACTRN12613000267752

Ethics application status

Approved

Date submitted

11/02/2013

Date registered

6/03/2013

Date last updated

15/04/2024

Date data sharing statement initially provided

15/04/2024

Date results provided

15/04/2024

Type of registration

Retrospectively registered

Titles & IDs

Public title

A study to validate a classification algorithm for Chronic low back pain participants using spinal injection as a comparison to measure improvement in symptoms.

Scientific title

A study to validate a classification algorithm for Chronic low back pain participants using spinal injection as a comparison to measure improvement in symptoms.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1139-3384

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Low back pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Physiotherapy diagnostic classification and examination ( modified McKenzie diagnostic classification),measurement of transversus abdominis and lumbar multifidus muscle using real time ultrasound scanning, flouroscopy guided spinal (either facet, foraminal or epidural) injections - conducted by a neurosurgeon, and determined by the neurosurgeon diagnosis. The procedure consists of instillation of less than 30 mls of 0.25% Bupivicaine (Marcaine) or less than 10 mls of 1% Lignocaine, and 40 mg (per vial) of Methylprednisolone (Depomedrone) as determined by the attending neurosurgeon, into the predetermined spinal structure
Duration of intervention 2hours with two repeat sessions consisting of a 2 week phone interview and 3 month post injection 20minute reexamination. Flouroscopy guided injection as reference standard. This is the usual treatment that would be applied to the study cohort.

Intervention code [1]

Diagnosis / Prognosis

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Visual Analogue pain scale and Numeric pain scale

Timepoint [1]

pre spinal injection, within one hour post injection, two weeks, and 3 months post injection

Primary outcome [2]

Oswestry disability index and Roland Morris back pain questionaire

Timepoint [2]

pre injection, within one hour post injection, two weeks and 3 months post injection

Primary outcome [3]

measurement of Transversus abdominis and Lumbar multifidus muscles with real time ultrasound

Timepoint [3]

pre injection, within one hour post injection

Secondary outcome [1]

Level of agreement between physiotherapist and neurosurgeon examination results. Assessed using standardised examination forms. Agreement tables will be used and % of agreement and Kappa correlation coefficients calculate the after chance agreement between the two examination outcomes.

Timepoint [1]

Pre injection

Eligibility

Key inclusion criteria

Adults presenting with pain of spinal origin and distribution below T12. of duration greater than 12 weeks.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Post spinal surgery previous twelve months, serious medical pathology, systemic inflammatory conditions such as rheumatoid Arthritis or Ankylosing Spondylitis, pregnancy, psychological or physical disorders which would render the participant unable to tolerate the examination/study process. < 18years old

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Subjects volunteer following invitation during their attendance at the health facility where the study will be conducted. Subjects receive the reference standard injection intervention only if it is clinically/ medically indicated following routine examination by the neurosurgeon.
Physiotherapy diagnostic classification examination is conducted on all volunteers regardless of whether a spinal injection procedure is administered subsequently
"Allocation is not concealed"

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Not-randomised

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

An independant assistant will input data from the physiotherapy examination proforma into an excel spreadsheet in a format suitable for import to SPSS statistical analysis software (version 20). Physiotherapy classification and neurosurgeon diagnosis will be coded and entered into the same spread sheet.
Demographic data will be analysed Diagnostic classification validity will be determined by correlation analysis with ‘positive participant response’ to spinal injection. Pre and post injection data will be analysed using SPSS version 20 [SPSS inc., Chicago, IL]. This analysis will specifically include pre and post injection pain rating, provocative movement and muscle size measures.
To assess the levels of agreement the distribution of classification judgements will be compared between the physiotherapy classification system and the neurosurgeon’s diagnosis. For each study participant, comparison of the physiotherapy classification and neurosurgeon’s diagnosis will be conducted and categorized as “in agreement” (same classification and diagnostic judgment for both raters) or “in disagreement” (different classification judgments for each rater). Participants will be grouped according to the following outcomes for each classification subgroup:

Using the spinal injection as the reference standard an analysis of the level of agreement and disagreement to establish sensitivity and specificity between physiotherapy classification, neurosurgeon diagnosis and spinal injection outcome will also be conducted. For each participant whose classification and injection code agree, a level of > 50% improvement in VAS and NPS will indicate a clinically significant improvement post injection.
Overall agreement will be calculated as the percentage of classification & diagnosis judgements in which both examiners were “in agreement”, compared to the total number of possible combinations for both examiners. Contingency tables will establish numbers to calculate the overall percentage agreement. A Kappa coefficient statistic will be used to measure the after chance proportion of agreement between examiners. An un-weighted kappa coefficient will calculate the overall agreement of CLBP classification into diagnostic categories (these will be determined by final physiotherapy classification and neurosurgeon diagnosis codes) with 95% confidence intervals. Any patterns of disagreement between the classification protocol and neurosurgeon will also be evaluated with analysis of predictors of outcome for each classification using linear regression. Predictors will be pre procedure reported pain levels and scores from the quality of life (ODI and RM) and the psychosocial (MSPQ) questionnaires. However, it is anticipated that participant numbers for each classification specific subgroup may be small and therefore linear regression may not be possible.
RTUS images will be measured and muscle activation will be calculated as a percentage of thickness change between rest and sub-maximal contraction. The mean percentage change for the three repeated measurements from rest to submaximal contraction will be calculated, and a one-way ANOVA will analyse differences between the pre and post injection measurements. Significance level will be set at P < 0.05.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

25/02/2013

Actual

4/03/2013

Date of last participant enrolment

Anticipated

Actual

21/09/2015

Date of last data collection

Anticipated

Actual

30/09/2015

Sample size

Target

100

Accrual to date

Final

200

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Townsville Hospital - Douglas

Recruitment hospital [2]

Mater Hospital Pimlico - Pimlico

Recruitment postcode(s) [1]

4811 - James Cook University

Recruitment postcode(s) [2]

4812 - Pimlico

Funding & Sponsors

Funding source category [1]

University

Name [1]

James Cook University

Address [1]

James cook Drive
Douglas Townsville
4811
QLD

Country [1]

Australia

Primary sponsor type

Individual

Name

Miss Carol Ann Flavell

Address

Discipline of Physiotherapy
James cook University
James cook Drive
Douglas Townsville
4811
QLD

Country

Australia

Secondary sponsor category [1]

University

Name [1]

James cook university

Address [1]

Douglas
Townsville
4811
QLD

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Associate Professor Laurence Marshman

Address [1]

Neurosurgeon
The Townsville Hospital
100 Angus Smith Drive, Douglas QLD 4814
Mailing Address: P.O. Box 670, Townsville QLD 4810

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Professor Susan Gordon

Address [2]

Strategic Professor - Chair of Restorative Care
School of Health Sciences, Rehabilitation and Aged Care
Repatriation General Hospital
Flinders University
Sturt Road,
Bedford Park 5042,
South Australia

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Associate Professor Kerrianne Watt

Address [3]

Discipline of public and indigenous health
Anton Brienl center
James cook University
Douglas
Townsville
4811
QLD

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Townsville Health Service District Institutional Ethics Committee

Ethics committee address [1]

Townsville Hospital
100 Angus Smith Drive, Douglas QLD 4814
Mailing Address: P.O. Box 670, Townsville QLD 4810

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/03/2012

Ethics approval number [1]

HREC/10/QTHS/53

Ethics committee name [2]

James Cook University Human Research ethics committee

Ethics committee address [2]

James Cook University
Townsville Campus
Douglas 4811
QLD

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

16/03/2012

Ethics approval number [2]

H4387

Summary

Brief summary

There are 3 components to this research study.Prior to assessment patients will be asked to completequality of life (QOL) and disability surveys and a visual analogue score (VAS) of their pain. 
1. The McKenzie diagnostic classification (MKD) is used during examination of patients with chronic low
back pain (CLBP) to determine if a joint or disc is likely to be the source of symptoms. It requires the patient
to repeat movements in a number of directions. To determine the validity of this classification system
physiotherapists will assess patients attending the Townsville Hospital Pain Clinic using the MKD. A
neurosurgeon will also examine the patients and at the discretion of the neurosurgeon an injection of the
joint or area surrounding the spinal nerves with anaesthetic and corticosteroid will be performed. The patient
will be reassessed using MKD to determine if the injection has altered the pain response and range of
motion. Outcome measures will be range of motion (ROM), response to MKD and (VAS) for pain.
2. It is known that the core trunk muscles supporting the spine 'switch-off' when pain is present but it is
unknown what direct effect pain relieving injections have on the short term and long term function of the core
muscles. Hence, patient core muscle function will also be assessed prior to and after injection using
ultrasonography.
We hypothesise that the physiotherapy classification pathway will be a valid physiotherapy diagnostic indicator for CLBP patients.  We also hypothesise that the deep spinal postural muscles (transversus abdominis and Lumbar Multifidus) do not immediately start to function normally post spinal anaesthetic injection.

Trial website

Trial related presentations / publications

Flavell, C.A., S. Gordon, and L. Marshman, Association between symptom duration and intensity, disability, range of motion and modified pain perceptions amongst chronic low back pain patients. Physiotherapy, 2015. 101: p. e390.
Flavell, C.A., S. Gordon, and L. Marshman, Classification characteristics of a chronic low back pain population using a combined McKenzie and patho-anatomical assessment. Manual Therapy, 2016. 26: p. 201-207.
Flavell, C., S. Gordon, and L. Marshman, Reply to the letter to the editor regarding ‘Classification characteristics of a chronic low back pain population using a combined McKenzie and patho-anatomical assessment’. Musculoskeletal Science and Practice, 2017. 27: p. e7.

Public notes

Contacts

Principal investigator

Name

Miss Carol Ann Flavell

Address

Discipline of Physiotherapy
James Cook university
Douglas 4811
Townsville
QLD

Country

Australia

Phone

+61747816472

Fax

+61747816868

carol.flavell@jcu.edu.au

Contact person for public queries

Name

Carol Ann Flavell

Address

Discipline of Physiotherapy
James Cook university
Douglas 4811
Townsville
QLD

Country

Australia

Phone

+61747816472

Fax

+61747816868

carol.flavell@jcu.edu.au

Contact person for scientific queries

Name

Carol Ann Flavell

Address

Discipline of Physiotherapy
James Cook university
Douglas 4811
Townsville
QLD

Country

Australia

Phone

+61747816472

Fax

carol.flavell@jcu.edu.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

Individual participant data will never be made available due to ethical consideration of confidentiality of personal and medical information

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

Source	Title	Year of Publication	DOI
Embase	Classification characteristics of a chronic low back pain population using a combined McKenzie and patho-anatomical assessment.	2016	https://dx.doi.org/10.1016/j.math.2016.10.002

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically