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Trial registered on ANZCTR


Registration number
ACTRN12618001289202
Ethics application status
Approved
Date submitted
27/07/2018
Date registered
31/07/2018
Date last updated
6/05/2019
Date data sharing statement initially provided
6/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring threat and fragility in individuals with low back pain
Scientific title
Exploring threat and fragility in individuals with low back pain
Secondary ID [1] 295678 0
None
Universal Trial Number (UTN)
U1111-1218-2148
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 309045 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307936 307936 0 0
Other physical medicine / rehabilitation
Musculoskeletal 307950 307950 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This project will use an online survey to profile beliefs regarding fragility of the back, its fitness for purpose and the resultant sense of threat in patients experiencing low back pain. To this end, we have developed a novel questionnaire. This project will take 3 stages.

Firstly, a qualitative component seeking feedback from a small group of people (n = 10) with LBP in order to further refine the new tool will be conducted. These participant will answer survey online and participate in a 20 minute semi-structured phone interview.

Then, having reviewed and refined the new questionnaire we will distribute amongst a larger cohort (200) to be answered online.

We will also ask a small subset of these participants (n= 22, no specific criteria) to repeat the online questionnaire within 24 hours to assess the test-retest reliability. Finally, convergent validity will be explored by comparing the responses to relevant questionnaires.
Intervention code [1] 301996 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306907 0
Threat and Fragility score (questionnaire yet to be named)

The new questionnaire contains 21 statements considered to reflect beliefs regarding fragility of the back, its fitness for purpose and the resultant sense of threat in patients experiencing LBP. Response options ranging from “agree” to “disagree” with options, partially agree, unsure, partially disagree. Statements were written in first person to ensure participants response was in relation with their own back pain experience. The agree option is intended to reflect high levels of threat and fragility, items (1&12) are reversed compared to the other questions. These 21 questions are presented sequentially into 5 key domains 1) your back, 2) protecting your back, 3) back pain, 4) life with back pain and 5) the future.
Scoring
Scores for each question are calculated from 1-5 for each statement with 5 representing more unhelpful beliefs and a higher overall score indicating the participant harbors high levels of maladaptive beliefs.
Timepoint [1] 306907 0
Cross sectional
Secondary outcome [1] 350059 0
Tampa scale of kinesiophobia
Timepoint [1] 350059 0
Cross sectional
Secondary outcome [2] 350060 0
Pain catastropisation scale
Timepoint [2] 350060 0
Cross sectional
Secondary outcome [3] 350061 0
Back pain attitudes questionnaire
Timepoint [3] 350061 0
Cross sectional
Secondary outcome [4] 350062 0
Health Anxiety Inventory
Timepoint [4] 350062 0
Cross sectional
Secondary outcome [5] 350063 0
Pain Anxiety Symptom Scale
Timepoint [5] 350063 0
Cross sectional
Secondary outcome [6] 350064 0
Pain Self-Efficacy Questionnaire
Timepoint [6] 350064 0
Cross sectional

Eligibility
Key inclusion criteria
Participants must be aged between 18-70, reside in Australia are fluent in English and experience low back pain.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not resident in Australia, not English speaking, under 18 and over 70 years of age.
Note, participants will be screened for potential serious pathology using the MYBACK questionnaire (myback.neura.edu.au) at the end of the survey. Thus their survey data may be included in our analyses but we can still screen for the potential presence of serious / specific pathology.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We intend to recruit 200 participants. This sample size is sufficient to produce acceptable estimates of population values when there is a ratio of 10 items to 3 factors, with low communalities.

22 participants will repeat the questionnaire within 24 hours to assess test-retest reliability. This subsample is sufficient to detect a difference between an intra-class correlation coefficient of 0.5 and 0, at alpha=0.05 with 80% power.

Patient characteristics will be described using means/standard deviations, medians/interquartile range and frequency/percentage as appropriate.

Internal consistency will be assessed using Cronbach’s alpha, with alpha >= 0.7 assumed to be an acceptable value. Test-retest reliability will be measured using intra-class correlation coefficient from a two-way random effects model (ICC(2,1)). Bland-Altman plots will be generated to examine agreement.

Dimensionality of the instrument will be assessed using exploratory factor analysis.
To investigate validity of the instrument, correlations (Pearson’s r or Spearman’s rho as appropriate) between the total scores for this questionnaire and the Tampa scale of Kinesiophobia, Pain Catastrophizing Scale, Back-PAQ, Health Anxiety Inventory, Pain Anxiety Symptom Scale, and Pain Self-Efficacy Questionnaire will be computed. In addition, scatterplots/regression will be used to assess linearity between the new and existing instruments.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2018
Actual
17/09/2018
Date of last participant enrolment
Anticipated
31/01/2019
Actual
1/05/2019
Date of last data collection
Anticipated
19/07/2019
Actual
1/05/2019
Sample size
Target
200
Accrual to date
Final
201
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300263 0
University
Name [1] 300263 0
Curtin University
Country [1] 300263 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
School of Physiotherapy and Exercise Science
Curtin University
Building 408,
Brand Drive,
Bentley
WA 6102
Country
Australia
Secondary sponsor category [1] 299689 0
None
Name [1] 299689 0
Address [1] 299689 0
Country [1] 299689 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301080 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 301080 0
Ethics committee country [1] 301080 0
Australia
Date submitted for ethics approval [1] 301080 0
Approval date [1] 301080 0
26/07/2018
Ethics approval number [1] 301080 0

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

Contacts
Principal investigator
Name 85814 0
Dr Mervyn Travers
Address 85814 0
School of Physiotherapy and Exercise Science,
Curtin University
Building 408,
Brand Drive,
Bentley
WA 6102
Country 85814 0
Australia
Phone 85814 0
+61 8 9266 5282
Fax 85814 0
Email 85814 0
m.travers@curtin.edu.au
Contact person for public queries
Name 85815 0
Mervyn Travers
Address 85815 0
School of Physiotherapy and Exercise Science,
Curtin University
Building 408,
Brand Drive,
Bentley
WA 6102
Country 85815 0
Australia
Phone 85815 0
+61 8 9266 5282
Fax 85815 0
Email 85815 0
m.travers@curtin.edu.au
Contact person for scientific queries
Name 85816 0
Mervyn Travers
Address 85816 0
School of Physiotherapy and Exercise Science,
Curtin University
Building 408,
Brand Drive,
Bentley
WA 6102
Country 85816 0
Australia
Phone 85816 0
+61 8 9266 5282
Fax 85816 0
Email 85816 0
m.travers@curtin.edu.au

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)?
Start: Immediately following publication
End: No end date determined
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


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.