Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001062516p
Ethics application status
Not yet submitted
Date submitted
2/08/2024
Date registered
3/09/2024
Date last updated
3/09/2024
Date data sharing statement initially provided
3/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
FusiOn veRsus bEst coNServatIve Care (the FORENSIC-Australia trial)
Scientific title
The clinical and cost-effectiveness of lumbar fusion surgery for patients with persistent, severe low back pain: FusiOn veRsus bEst coNServatIve Care (the FORENSIC-Australia trial)
Secondary ID [1] 312610 0
None
Universal Trial Number (UTN)
Trial acronym
FORENSIC-Australia
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent, severe low back pain 334547 0
Lumbar spine degeneration (with imaging evidence) deemed suitable for lumbar fusion surgery at 1 or 2 levels 334902 0
Condition category
Condition code
Musculoskeletal 331149 331149 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 331150 331150 0 0
Physiotherapy
Physical Medicine / Rehabilitation 331151 331151 0 0
Other physical medicine / rehabilitation
Surgery 331152 331152 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lumbar Fusion Surgery (LFS): 1 or 2 level LFS, either intertransverse or interbody. LFS is used routinely in Australia. All commonly accepted fusion methods and graft options within Australia will be permitted. The exceptions are:
1) the use of bone morphogenic protein (BMP), given it is not common practice, is expensive and the clinical advisory group (CAG) working up the trial protocol felt strongly it could be a confounder.
2) mixed fusion procedures (i.e., fusion with decompression, fusion with disc replacement at the same or different levels).
Other than the above BMP and mixed fusion procedures, no limitations (within accepted methods) for implants, bone grafts or surgical approach, given the evidence that none are superior.

The LFS will be performed by skilled Neurosurgeons or Orthopaedic surgeons in the FORENSIC-Australia trial.

The LFS intervention includes usual practice of the participating surgeon at the site (i.e., usual pre-/postoperative imaging, usual review appointment(s) and usual post-operative care). There is low-quality evidence of the effectiveness of physiotherapy following LFS and therefore usual post-operative care at participating sites will be offered and recorded.

Intervention details will be recorded on the treatment case report form.
Intervention code [1] 329121 0
Treatment: Surgery
Intervention code [2] 329358 0
Treatment: Other
Comparator / control treatment
The Best Conservative Care (BCC) options recommended in the Australian Low Back Pain Standards, the National Institute for Health and Care Excellence (NICE) Low Back Pain guidelines, and the World Health Organization (WHO) guideline for non-surgical management of chronic primary low back pain:
• Support for active self-management (e.g., advice and education regarding pacing, diagnosis, aetiology, return to work, non-supervised exercise).
• Structured and supervised exercise therapy with or without manual therapy, with a healthcare professional.
• Structured and supervised psychological programme (e.g., Psychologist, Cognitive Behavioural Therapy, Acceptance and Commitment Therapy, behavioural therapist, counselling).
• Structured and supervised combined physical and psychological programme (CPPP)
• Structured and supervised programme of treatment led by a pain service
• Radiofrequency denervation
• Other (e.g., signposting to other health material, online resources, or interventions or referral to other health professionals)

How the choice of each component will be determined:
All participants randomised to the BCC control arm will be reviewed by a clinician, with experience in assessing and treating patients with LBP with links to a wider multidisciplinary team (MDT). This review will involve a comprehensive biopsychosocial assessment, including a clinical evaluation of recent imaging findings, a formulation of the patient’s case, a review of previous treatment and its effectiveness as perceived by the participant. A tailored package of care based on the BCC options locally available at the participating site, clinician’s assessment, and the participant’s goals, abilities and expectations through shared decision-making and labelled as ‘Personalised Spinal Care’.

Intervention details will be recorded on the treatment case report form.
Control group
Active

Outcomes
Primary outcome [1] 338902 0
Low back pain-related disability
Timepoint [1] 338902 0
The ODI will be assessed at baseline, and at 6-, 12-, and 24-months (primary timepoint) post-randomisation.
Secondary outcome [1] 437871 0
Low back pain intensity
Timepoint [1] 437871 0
This measure is assessed monthly (from randomisation) over 24 months.
Secondary outcome [2] 437872 0
Patient-rated recovery since baseline
Timepoint [2] 437872 0
This measure is assessed at 6-, 12-, and 24-months post-randomisation.
Secondary outcome [3] 437873 0
Health-related quality of life
Timepoint [3] 437873 0
This measure is assessed at baseline, and at 6-, 12-, and 24-months post-randomisation.
Secondary outcome [4] 437874 0
Depression
Timepoint [4] 437874 0
This measure is assessed at baseline, and at 6-, 12-, and 24-months post-randomisation.
Secondary outcome [5] 437875 0
Movement fear avoidance beliefs
Timepoint [5] 437875 0
This measure is assessed at baseline, and at 6-, 12-, and 24-months post-randomisation.
Secondary outcome [6] 437876 0
Pain self-efficacy
Timepoint [6] 437876 0
This measure is assessed at baseline, and at 6-, 12-, and 24-months post-randomisation.
Secondary outcome [7] 437877 0
Work status
Timepoint [7] 437877 0
Work status is assessed at baseline, and at 6-, 12-, and 24-months post-randomisation.
Secondary outcome [8] 437878 0
Occupation type
Timepoint [8] 437878 0
Occupation type is assessed at baseline only.
Secondary outcome [9] 437879 0
Work outcomes
Timepoint [9] 437879 0
Work outcomes is assessed at 6-, 12-, and 24-months post-randomisation.
Secondary outcome [10] 437880 0
Treatment satisfaction
Timepoint [10] 437880 0
This measure is assessed at 6-, 12-, and 24-months post-randomisation.
Secondary outcome [11] 437881 0
Patient-reported health care resource use
Timepoint [11] 437881 0
This measure is assessed at 6-, 12-, and 24-months post-randomisation.
Secondary outcome [12] 439060 0
Complications/Expected adverse events
Timepoint [12] 439060 0
This measure is assessed during and after treatment in the trial and when participants self-report adverse events at any time during the trial. The CRF is completed on an as-needed basis throughout the trial.
Secondary outcome [13] 439061 0
CT Scan results (Lumbar Fusion Surgery arm only)
Timepoint [13] 439061 0
This measure is assessed at 24-months post-randomisation in those participants who received lumbar fusion surgery.

Eligibility
Key inclusion criteria
A patient will be eligible for inclusion if ALL of the following criteria apply:
• Adults aged 18-65 years old. Patients over 65 years old are excluded given the increasing prevalence of spinal stenosis seen in older adults i.e. a change in pathology involving neurological compression requiring a different surgery.
• Episode of low back pain (lasting 6 months or longer)
• Low back pain severity is more than or equal to 6 on a 0-10 numeric rating scale (NRS)
• With or without previous discectomy/decompression
• Have undergone one or more of the following previous treatment for LBP recommended in guidelines/standards:
o structured and supervised exercise therapy with or without manual therapy, with a healthcare professional
o structured and supervised psychological programme
o structured and supervised combined physical and psychological programme (CPPP)
o structured and supervised programme of treatment led by a pain service
o radiofrequency denervation
(Previous recommended treatment(s) may have been delivered virtually, face to face, individually or in a group.)
• Recent evidence of lumbar spine degenerative changes using appropriate imaging (Magnetic Resonance Imaging (within the last 12 months) [MRI] +/- Single Photon Emission Computed Tomography-Computed Tomography [SPECT-CT]).
• Assessed as suitable for both LFS at 1 or 2 lumbar spine levels and BCC by a participating surgeon
• Able to give full informed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A patient will not be eligible for the study if ANY of the following apply:
• Has low back-related leg pain more severe than their low back pain
• Has pain in other body regions that is more severe than their low back pain
• Radiculopathy or claudication or clinical signs of nerve compression where the treatment plan includes offering direct or indirect spinal decompression along with the fusion
• Other reasons indicated for LFS (e.g. lumbar spine deformity, infection, tumours, instability due to spondylolisthesis of grade 2 or above, spinal fracture, systemic inflammatory disease)
• Previous (or attempted) LFS
• Psychiatric conditions (e.g., diagnosed personality disorders, post-traumatic stress disorder, drug or alcohol abuse/addictions, diagnosis of severe depression)
• Is pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Web-based randomisation system (REDCap)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The computer-generated 1:1 randomisation schedules will be provided to the database programmer by an independent statistician using random blocks of various sizes.
Stratification factors:
• Trial site
• Number of lumbar spine levels indicated for spinal fusion (1 or 2 levels)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We estimate needing 270 patients (135 per arm) to be randomised, based on a between-arm target difference of 8 points on the ODI with an expected standard deviation of 18, as observed in similar populations using a 2-sided 5% significance level, 90% power and allowing for up to 20% loss to follow-up. The target difference is considered important by the consumer engagement discussions during the development of the trial plan, is smaller than the commonly accepted Minimum Clinical Important Difference (MCID) of 10 points on the ODI, to allow for some dilution of the treatment effect due to protocol deviation (including some modest crossover from LFS to BCC) and corresponds to a moderate effect size of 0.44.

Description of Statistical Methods
Unless stated otherwise, analyses and summaries will be based on the as-randomised population, whereby participants will be analysed in line with their randomisation allocation regardless of adherence to the study protocol.

The primary outcome measure will be summarised descriptively by arm at baseline and all follow-up time-points. Differences between the arms will be estimated using a multilevel mixed effects regression model, allowing for repeated measures clustered within participants. Covariates will include the number of levels indicated for spinal fusion (1 or 2 levels), baseline ODI, time, arm and time by arm interactions (fixed factors), participant and randomising site (random factors). Time will be used as a categorical variable, indicating the protocol stipulated follow-up time-point for assessment. Adjusted mean differences between the arms will be presented together with 95% confidence intervals and p-values at each follow-up time-point. A number of other analyses may be performed such as area under the curve analysis.

Secondary outcomes will be analysed using multilevel mixed effects regression models in line with the primary analysis of the primary outcome.
Adverse events will be presented descriptively.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
1/11/2026
Actual
Date of last data collection
Anticipated
1/11/2028
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 26849 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 26850 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [3] 26851 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [4] 26852 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [5] 26853 0
Mount Hospital - Perth
Recruitment postcode(s) [1] 42911 0
4029 - Herston
Recruitment postcode(s) [2] 42912 0
6150 - Murdoch
Recruitment postcode(s) [3] 42913 0
6008 - Subiaco
Recruitment postcode(s) [4] 42914 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 317039 0
Government body
Name [1] 317039 0
National Health and Medical Research Council (NHMRC)
Country [1] 317039 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 319286 0
None
Name [1] 319286 0
Address [1] 319286 0
Country [1] 319286 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315795 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 315795 0
Ethics committee country [1] 315795 0
Australia
Date submitted for ethics approval [1] 315795 0
02/10/2024
Approval date [1] 315795 0
Ethics approval number [1] 315795 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135818 0
Prof Nadine Foster
Address 135818 0
STARS Education and Research Alliance (SERA), Level 7, Surgical Treatment and Rehabilitation Services (STARS) building, 296 Herston Road, Herston, QLD 4006
Country 135818 0
Australia
Phone 135818 0
+61 7 336 55226
Fax 135818 0
Email 135818 0
[email protected]
Contact person for public queries
Name 135819 0
Dr Angela Ching
Address 135819 0
STARS Education and Research Alliance (SERA), Level 7, Surgical Treatment and Rehabilitation Services (STARS) building, 296 Herston Road, Herston, QLD 4006
Country 135819 0
Australia
Phone 135819 0
+61 461 378 578
Fax 135819 0
Email 135819 0
[email protected]
Contact person for scientific queries
Name 135820 0
Nadine Foster
Address 135820 0
STARS Education and Research Alliance (SERA), Level 7, Surgical Treatment and Rehabilitation Services (STARS) building, 296 Herston Road, Herston, QLD 4006
Country 135820 0
Australia
Phone 135820 0
+61 7 336 55226
Fax 135820 0
Email 135820 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
After publication of the trial results and agreed publications from the FORENSIC-Australia publication plan.
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator (email: [email protected])


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.