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
ACTRN12613000267752
Ethics application status
Approved
Date submitted
11/02/2013
Date registered
6/03/2013
Date last updated
26/09/2017
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] 281920 0
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 288317 0
Condition category
Condition code
Musculoskeletal 288672 288672 0 0
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] 286484 0
Diagnosis / Prognosis
Intervention code [2] 286660 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288828 0
Visual Analogue pain scale and Numeric pain scale
Timepoint [1] 288828 0
pre spinal injection, within one hour post injection, two weeks, and 3 months post injection
Primary outcome [2] 288829 0
Oswestry disability index and Roland Morris back pain questionaire
Timepoint [2] 288829 0
pre injection, within one hour post injection, two weeks and 3 months post injection
Primary outcome [3] 288830 0
measurement of Transversus abdominis and Lumbar multifidus muscles with real time ultrasound
Timepoint [3] 288830 0
pre injection, within one hour post injection
Secondary outcome [1] 301082 0
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] 301082 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 560 0
The Townsville Hospital - Douglas
Recruitment hospital [2] 9111 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 6301 0
4811 - James Cook University
Recruitment postcode(s) [2] 17611 0
4812 - Pimlico

Funding & Sponsors
Funding source category [1] 286711 0
University
Name [1] 286711 0
James Cook University
Address [1] 286711 0
James cook Drive
Douglas Townsville
4811
QLD
Country [1] 286711 0
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] 285483 0
University
Name [1] 285483 0
James cook university
Address [1] 285483 0
Douglas
Townsville
4811
QLD
Country [1] 285483 0
Australia
Other collaborator category [1] 277274 0
Individual
Name [1] 277274 0
Associate Professor Laurence Marshman
Address [1] 277274 0
Neurosurgeon
The Townsville Hospital
100 Angus Smith Drive, Douglas QLD 4814
Mailing Address: P.O. Box 670, Townsville QLD 4810


Country [1] 277274 0
Australia
Other collaborator category [2] 277275 0
Individual
Name [2] 277275 0
Professor Susan Gordon
Address [2] 277275 0
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] 277275 0
Australia
Other collaborator category [3] 277276 0
Individual
Name [3] 277276 0
Associate Professor Kerrianne Watt
Address [3] 277276 0
Discipline of public and indigenous health
Anton Brienl center
James cook University
Douglas
Townsville
4811
QLD
Country [3] 277276 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288786 0
The Townsville Health Service District Institutional Ethics Committee
Ethics committee address [1] 288786 0
Townsville Hospital
100 Angus Smith Drive, Douglas QLD 4814
Mailing Address: P.O. Box 670, Townsville QLD 4810
Ethics committee country [1] 288786 0
Australia
Date submitted for ethics approval [1] 288786 0
Approval date [1] 288786 0
15/03/2012
Ethics approval number [1] 288786 0
HREC/10/QTHS/53
Ethics committee name [2] 288787 0
James Cook University Human Research ethics committee
Ethics committee address [2] 288787 0
James Cook University
Townsville Campus
Douglas 4811
QLD
Ethics committee country [2] 288787 0
Australia
Date submitted for ethics approval [2] 288787 0
Approval date [2] 288787 0
16/03/2012
Ethics approval number [2] 288787 0
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 37714 0
Miss Carol Ann Flavell
Address 37714 0
Discipline of Physiotherapy
James Cook university
Douglas 4811
Townsville
QLD
Country 37714 0
Australia
Phone 37714 0
+61747816472
Fax 37714 0
+61747816868
Email 37714 0
carol.flavell@jcu.edu.au
Contact person for public queries
Name 37715 0
Miss Carol Ann Flavell
Address 37715 0
Discipline of Physiotherapy
James Cook university
Douglas 4811
Townsville
QLD
Country 37715 0
Australia
Phone 37715 0
+61747816472
Fax 37715 0
+61747816868
Email 37715 0
carol.flavell@jcu.edu.au
Contact person for scientific queries
Name 37716 0
Miss Carol Ann Flavell
Address 37716 0
Discipline of Physiotherapy
James Cook university
Douglas 4811
Townsville
QLD
Country 37716 0
Australia
Phone 37716 0
+61747816472
Fax 37716 0
Email 37716 0
carol.flavell@jcu.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary