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Trial registered on ANZCTR


Registration number
ACTRN12615001080516
Ethics application status
Approved
Date submitted
29/01/2015
Date registered
14/10/2015
Date last updated
22/06/2021
Date data sharing statement initially provided
22/06/2021
Date results provided
22/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Are early somatosensory abnormalities after back pain a biomarker for chronic pain?
Scientific title
Do somatosensory abnormalities predict non recovery in patients with acute low back pain?
Secondary ID [1] 285837 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain with or without leg pain 293650 0
Condition category
Condition code
Musculoskeletal 293947 293947 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 294436 294436 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this observational study, participants will be assessed first within 3 weeks from onset of low back pain. The assessment will take approximately 2 hours and it will involve baseline data collection, questionnaires administration and quantitative sensory testing (QST). In addition, an evidence-based booklet of basic advice on the management of low back pain that aligns with practice guidelines ("The Back Book") will be provided to all participants. Data collection will include:
- Extent of recovery (Back Pain Recovery Scale);
- Pain intensity (0-10 VAS pain scale);
- Self-reported functional status (Functional Rating Index Scale);
- Self-reported disability (Roland Morris Disability questionnaire);
- Sensory and affective dimensions of pain (Short-From McGill Pain questionnaire);
- Neuropathic pain screening (PainDETECT questionnaire);
- Psychological features (Pain-Self Efficacy questionnaire (PSEQ), Depression, anxiety and stress (DASS-21), Pain catastrophizing Scale (PCS)).

QST assessment will be performed by one trained physiotherapist blinded to participants' condition using standardized protocols and it will include the following tests: cold and heat pain threshold, wind-up ratio, pressure pain threshold, two-point discrimination threshold, thermal temporal summation, conditioned pain modulation (CPM). QST measures will be taken at the back bilaterally (cold and heat pain threshold, wind-up ratio, pressure pain threshold, two point-discrimination threshold) and from the left hand as a remote control site (cold and heat pain threshold, wind-up ratio, pressure pain threshold). Thermal temporal summation will be tested on the palmar surface of the hand. CPM will be performed using a cold bath as a conditioning stimulus and two test stimuli, heat pain and pressure pain.

Participants will be reassessed after 2 months and 4 months. In these sessions, QST measurements and clinical information (e.g. questionnaires) will be collected.

Participants will be contacted at 6 months after LBP onset to attain pain scores and recovery status.
Intervention code [1] 290727 0
Not applicable
Comparator / control treatment
QST data from healthy controls will be attained for comparison at three time points (baseline assessment and after 2 months and 4 months). QST measurements will be performed in the same manner as for participants with low back pain.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293763 0
The primary measure of extent of recovery was measured with Pain Intensity, where non-recovery is indicated by persistence of pain (0 or 1 out of 10 on an 11-point Numerical Pain Rating Scale) or recovered (2 or more out of 10 on the 11-point NPRS).
Timepoint [1] 293763 0
4 months and 6 months from onset of low back pain
Secondary outcome [1] 311778 0
Pain intensity (0-10 VAS pain scale)
Timepoint [1] 311778 0
4 months and 6 months from onset of low back pain
Secondary outcome [2] 311779 0
Functional level (Functional Rating Index)
Timepoint [2] 311779 0
4 months and 6 months from onset of low back pain

Eligibility
Key inclusion criteria
At least 18 years of age; low back pain with or without leg pain; pain duration within 3 weeks from onset; average pain intensity over the last few days at least 3 on a 11-point Numeric Pain Rating Scale.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Signs or symptoms of serious spinal pathology (e.g. tumor, infection, fracture); any pain condition in the past year that has lasted for >1/12 and affected daily function or work activity; diagnosed co-morbid pain syndrome (e.g. fibromyalgia, irritable bowel syndrome, osteoarthritis); medical condition known to affect the nervous system (i.e. neurological disease, diabetes); previous lumbar surgery; pregnancy; unstable psychiatric disorder; substance abuse; severe cognitive impairment (arising from head injury or other comorbidity); long term use of medications that may impact on cognitive or sensory function (e.g. opiates greater than daily morphine equivalent 40mg); unable to read, write and understand English.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Within the timeframe of this PhD study, 98 potentially eligible participants, 73 (25 people with LBP and 48 controls) provided consent to participate and were enrolled in the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/02/2015
Actual
26/02/2015
Date of last participant enrolment
Anticipated
Actual
29/04/2016
Date of last data collection
Anticipated
Actual
19/08/2016
Sample size
Target
60
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290415 0
University
Name [1] 290415 0
Centre for Physical Health, Macquarie University
Country [1] 290415 0
Australia
Funding source category [2] 308951 0
University
Name [2] 308951 0
Macquarie University NHMRC Safety Net Grant
Country [2] 308951 0
Australia
Primary sponsor type
Individual
Name
Dr Julia Hush
Address
Ground Floor 75 Talavera Road, Macquarie University
Macquarie Park, NSW 2109
Country
Australia
Secondary sponsor category [1] 289131 0
None
Name [1] 289131 0
Address [1] 289131 0
Country [1] 289131 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292039 0
Macquarie University Human Research Ethics Committee (HREC, Medical Sciences)
Ethics committee address [1] 292039 0
Ethics committee country [1] 292039 0
Australia
Date submitted for ethics approval [1] 292039 0
Approval date [1] 292039 0
28/08/2014
Ethics approval number [1] 292039 0
5201400840

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

Contacts
Principal investigator
Name 53182 0
A/Prof Julia Hush
Address 53182 0
Ground Floor 75 Talavera Road, Macquarie University
Macquarie Park, NSW 2109
Country 53182 0
Australia
Phone 53182 0
+61298506621
Fax 53182 0
Email 53182 0
julia.hush@mq.edu.au
Contact person for public queries
Name 53183 0
Julia Hush
Address 53183 0
Ground Floor 75 Talavera Road, Macquarie University
Macquarie Park, NSW 2109
Country 53183 0
Australia
Phone 53183 0
+61298506621
Fax 53183 0
Email 53183 0
julia.hush@mq.edu.au
Contact person for scientific queries
Name 53184 0
Julia Hush
Address 53184 0
Ground Floor 75 Talavera Road, Macquarie University
Macquarie Park, NSW 2109
Country 53184 0
Australia
Phone 53184 0
+61298506621
Fax 53184 0
Email 53184 0
julia.hush@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data can be provided on request from lead researcher Anna Marcuzzi


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.