Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000392561
Ethics application status
Approved
Date submitted
9/01/2024
Date registered
3/04/2024
Date last updated
3/04/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Abdominal bracing for adult acute low back pain in the Emergency Department: A randomised controlled trial exploring impact on pain, function and healthcare use.
Scientific title
Lumbar brace deployment in adults with acute benign low back pain attending the Emergency Department: Effectiveness and impact on pain, spine function, analgesic use and community resources.
Secondary ID [1] 311288 0
None
Universal Trial Number (UTN)
U1111-1302-4137
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Low Back Pain 332527 0
Condition category
Condition code
Musculoskeletal 329217 329217 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the Emergency Department will be screened (red flags) by their receiving doctor and have their medical interventions completed prior to being referred to the Senior Physiotherapist. The PT will complete the consent process and patients will then be allocated randomly to the intervention (brace + routine care) or control (routine care) group. For those allocated to the intervention group, an Aspen Horizon 627 elasticised abdominal brace, adjusted to accommodate each individual's girth will be fitted in the Emergency Department by qualified physiotherapist. The participant will be provided with all routine care around the fitting of the brace, namely reassurance, education and exercises as per the Australian National Clinical Care Standard for Low Back Pain (Sept 2022). Recruitment into the study is estimated to take 15 minutes, fitting the brace a further 15 minutes and all other routine care 30-45 minutes depending on the patient acuity, mobility and medical screen. The participant will be asked to wear the brace during the day for up to 30 days. They will complete their prescribed exercises and go about their functional and work tasks as able with the brace in situ. The adherence to the brace protocol will be surveyed 3 x per week and self-reported wear time will be recorded (survey received via sms link).
Intervention code [1] 327738 0
Treatment: Devices
Intervention code [2] 328070 0
Treatment: Other
Comparator / control treatment
Routine care as per Australian Commission for Safety and Quality in Health Care National Low Back Pain Standard. Routine care will involve a medical screen for red flags ie suspicion of complex or sinister pathology and eligibility for the study. If the patient is eligible and progresses in the ED, Senior Physiotherapists will conduct their routine care subjective and objective (physical) assessment including screening and identifying yellow flags ie psychosocial factors which may indicate poorer outcome or future recurrence of back pain. The routine care treatment will include an exercise and education package which includes printed resources (produced as part of ACSQHS Nat Clinical Standard), customised exercise prescription / advice and education tailored to patient assessment, particularly in relation to addressing yellow flags. Those recruited to the study will be followed up ~7-10 days after the initial assessment by a Senior Physiotherapist (researcher) to provide a telephone assessment and advice and, or recommendation to seek further treatment from a (local) primary care practitioner.
Control group
Active

Outcomes
Primary outcome [1] 337054 0
Pain
Timepoint [1] 337054 0
The primary outcome is pain report. It will be measured at baseline (Day 0) (at recruitment, prior to treatment); days 2, 4, 7 (week 1); days 9, 11, 14 (week 2); days 16, 18, 21 (week 3); days 23, 25, 28 (primary endpoint); day 60 (month 2 - 8 weeks after commencement of treatment); and, day 90 (month 3 - 12 weeks after commencement of treatment). Month 2 and 3 will be collected ~ 1 and 2 months respectively after cessation of treatment.
Secondary outcome [1] 430500 0
Function
Timepoint [1] 430500 0
Oswestry DI will be captured: At baseline (taken prior to commencement of treatment) and weeks 1, 2, 3, 4, 8 (2 months); 12 (3 months) after commencement of treatment. Month 2 and 3 will be collected ~ 1 and 2 months respectively after cessation of treatment.
Secondary outcome [2] 430501 0
Quality of Life
Timepoint [2] 430501 0
EQ-5D will be captured: At baseline (taken prior to commencement of treatment) and weeks 1, 2, 3, 4, 8 (2 months); 12 (3 months) after commencement of treatment. Month 2 and 3 will be collected ~ 1 and 2 months respectively after cessation of treatment.
Secondary outcome [3] 430502 0
Health care usage
Timepoint [3] 430502 0
The schedule will be anchored on recruitment (baseline) date ie day of attendance at ED. At baseline (health care contacts reported prior to commencement of treatment in ED for this instance of LBP) and then repeated question at weeks 1, 2, 3, 4, 8 (2 months after ED attendance); 12 (3 months after ED attendance) after commencement of treatment.
Secondary outcome [4] 432931 0
Adverse outcomes associated with wearing brace:
Any skin irritation or possible contact allergy which is worsening and, or not settling with standard advice (wear breaks, moisturiser application).
Timepoint [4] 432931 0
As per protocol, adverse outcomes may be reported at the 7 - 10 day telephone consultation.
Within 30 days (brace wear protocol) via sms survey responses at 2, 4, 7, 9, 11, 14, 16, 18, 21, 23, 25, 28 days.
Secondary outcome [5] 432932 0
Adverse outcomes associated with wearing brace:
Lower limb swelling which is worsening and, or not settling with standard advice (wear breaks).
Timepoint [5] 432932 0
As per protocol, adverse outcomes may be reported at the 7 - 10 day telephone consultation.
Within 30 days (brace wear protocol) via sms survey responses at 2, 4, 7, 9, 11, 14, 16, 18, 21, 23, 25, 28 days.
Secondary outcome [6] 432933 0
Analgesic use analysed as a composite measure (total number of tablets, all medication types). Type of medication and frequency will be recorded for descriptive analysis.
Timepoint [6] 432933 0
Analgesic use will be measured at baseline (Day 0) (referring to days prior to recruitment); days 2, 4, 7 (week 1); days 9, 11, 14 (week 2); days 16, 18, 21 (week 3); days 23, 25, 28; day 60 (month 2 - 8 weeks after commencement of treatment); and, day 90 (month 3 - 12 weeks after commencement of treatment).

Eligibility
Key inclusion criteria
1) aged between 18 and older;
2) ambulatory;
3) able to read and understand English;
4) living in Perth, Western Australia; and
5) presenting to the Emergency Department of the Armadale Hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) waist circumference <61 or >175cm;
2) back pain due to systemic or specific disease such as known cancer, spinal infection, fracture, or ankylosing spondylitis;
3) pregnancy;
4) significant compression of the spinal cord/nerves;
5) previous back surgery; and
6) on-going workers’ compensation or litigation cases.

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)
Central randomisation (computer)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation (n = 20)
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
A prioiri sample size estimation based on primary outcome indicated 66 participants would be required per group to acheive a power of 95% at P<0.05. To accommodate loss to follow up of 15%, 76 participants per group are planned (total sample = 152). We will employ a repeated measure ANOVA to compare groupwise pain level between brace (intervention) and routine care (control) groups. We will conduct univariate assessments appropriate to data distribution and use age, gender, and pain severity as potential covariates if randomisation does not result in group equivalence. We will also estimate the effect size of differences between and within the groups for pain using Cohen’s d.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/03/2024
Date of last participant enrolment
Anticipated
20/12/2024
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
152
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 25982 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment postcode(s) [1] 41833 0
6112 - Armadale

Funding & Sponsors
Funding source category [1] 315541 0
University
Name [1] 315541 0
University of Alberta
Country [1] 315541 0
Canada
Funding source category [2] 315544 0
Commercial sector/Industry
Name [2] 315544 0
Aspen Medical Products
Country [2] 315544 0
Australia
Primary sponsor type
University
Name
University of Alberta
Address
Research Ethics Office, 308 Campus Tower, 8625 – 112 Street, Edmonton, AB T6G 1K8
Country
Canada
Secondary sponsor category [1] 317628 0
University
Name [1] 317628 0
Curtin University
Address [1] 317628 0
Faculty of Health Sciences, Curtin University, Bentley, WA.
Country [1] 317628 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314441 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 314441 0
Kirkman House, 197 Wellington Street, Perth Western Australia 6000
Ethics committee country [1] 314441 0
Australia
Date submitted for ethics approval [1] 314441 0
21/11/2022
Approval date [1] 314441 0
20/03/2023
Ethics approval number [1] 314441 0
RGS5841
Ethics committee name [2] 314443 0
Curtin University Human Research Ethics Committee
Ethics committee address [2] 314443 0
Research Office at Curtin, GPO Box U1987, Perth. Western Australia 6845
Ethics committee country [2] 314443 0
Australia
Date submitted for ethics approval [2] 314443 0
20/03/2023
Approval date [2] 314443 0
30/03/2023
Ethics approval number [2] 314443 0
HRE2023-0158

Summary
Brief summary
This study will recruit participants who attend Armadale Hospital (public) Emergency Department (ED) with acute low back pain. They will be randomized into groups, and the intervention group fitted with an abdominal brace. The hypothesis is that in people with mechanical low back pain, wearing a brace will reduce their pain (and increase activity and quality of life [QoL]). The participants will be asked to wear the brace for up to 30 days when in pain during the day and if they feel that the brace is helpful. Low back pain, function, QoL and health care usage will be tracked for 3 months from the date of attendance at ED.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131594 0
A/Prof Dale Edgar
Address 131594 0
Armadale Kalamunda Group Health Service, 3056 Albany Hwy, Mt Nasura, WA, 6112
Country 131594 0
Australia
Phone 131594 0
+61413070384
Fax 131594 0
Email 131594 0
dale.edgar@health.wa.gov.au
Contact person for public queries
Name 131595 0
A/Prof Dale Edgar
Address 131595 0
Armadale Kalamunda Group Health Service, 3056 Albany Hwy, Mt Nasura, WA, 6112
Country 131595 0
Australia
Phone 131595 0
+61413070384
Fax 131595 0
Email 131595 0
dale.edgar@health.wa.gov.au
Contact person for scientific queries
Name 131596 0
A/Prof Dale Edgar
Address 131596 0
Armadale Kalamunda Group Health Service, 3056 Albany Hwy, Mt Nasura, WA, 6112
Country 131596 0
Australia
Phone 131596 0
+61413070384
Fax 131596 0
Email 131596 0
dale.edgar@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not HREC approved. Deidentified data will be shared with listed collaborators only.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21348Study protocol  dale.edgar@health.wa.gov.au Please email CPI.
21349Informed consent form  dale.edgar@health.wa.gov.au 387134-(Uploaded-04-03-2024-10-12-37)-Study-related document.docx
21350Clinical study report  dale.edgar@health.wa.gov.au N/A as at 4/03/2024. Please email CPI.
21351Ethical approval  dale.edgar@health.wa.gov.au 387134-(Uploaded-04-03-2024-10-13-45)-Study-related document.pdf
21352Data dictionary  dale.edgar@health.wa.gov.au In progress. Please email CPI.
21353Analytic code  dale.edgar@health.wa.gov.au N/A as at 4/03/2024
21354Statistical analysis plan  dale.edgar@health.wa.gov.au N/A as at 4/03/2024



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.