Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000892718
Ethics application status
Approved
Date submitted
11/05/2022
Date registered
22/06/2022
Date last updated
1/06/2023
Date data sharing statement initially provided
22/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chronic Low Back Pain Survey in Australia
Scientific title
An epidemiologic survey to characterise the types and management of chronic low back pain in Australia
Secondary ID [1] 307103 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back Pain 326263 0
Condition category
Condition code
Musculoskeletal 323567 323567 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
The study will be performed online after a participant is invited to respond and consents to the information being gathered. The survey will be made aware to the population using a patient recruitment service that will advertise the study via facebook, instagram, google, etc.
The questionnaire will ask questions about the pain the participant is currently experiencing, how they have previously managed and currently manage their pain, the success they have experienced with their current management strategies as well as their interest in learning about future research. Examples of the questions are - where on your body do you suffer pain, what score out of 10 would you rate your pain, what medication types and non-medication therapies do you use to control your pain and how long have you suffered with your pain. It should take approximately 15-20 minutes to complete the questionnaire.
Intervention code [1] 323553 0
Not applicable
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331320 0
To evaluate pain types using painDETECT in survey participants who identify as having lower back pain.
Assessed by review of responses to painDETECT questionnaire.
Timepoint [1] 331320 0
Once only at the time of enrolment.
Secondary outcome [1] 409518 0
Previous utilization of pain management strategies by survey participants who identify as having lower back pain including pharmacologic and non-pharmacologic categorization listings based on published Conventional Medical Management categories.
This will be assessed by reviewing the answers to questions asked during the survey. eg Has the medication been effective in your pain management / has the non-medication therapy been effective in your pain management.
Timepoint [1] 409518 0
Once only at the time of enrolment.
Secondary outcome [2] 409520 0
Understand the level of satisfaction amongst the CLBP community with their level of pain
management. Level of satisfaction will be assessed using a 7-point scale at various timepoints. Responses range from “very satisfied” to “very dissatisfied.”
Timepoint [2] 409520 0
Once only at the time of enrolment.
Secondary outcome [3] 411102 0
Willingness to consider other therapies will be evaluated by asking if they would be willing to consider changes to medications, non-medications or surgical interventions using a "yes", "no" or "unsure" checkbox response.
Timepoint [3] 411102 0
Once only at the time of enrolment.

Eligibility
Key inclusion criteria
Located in Australia
Have chronic (3 months or more) low back pain
Willing to read and electronically confirm consent to participate in the survey
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The statistical analyses will include standard descriptive analyses including means, medians, ranges and standard deviations and frequencies and percentages as appropriate to the variable types.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2022
Date of last participant enrolment
Anticipated
30/11/2022
Actual
15/11/2022
Date of last data collection
Anticipated
30/11/2022
Actual
15/11/2022
Sample size
Target
1000
Accrual to date
Final
1081
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311410 0
Commercial sector/Industry
Name [1] 311410 0
Presidio Medical AU Pty Ltd
Country [1] 311410 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cercare Pty Ltd
Address
5 Greenhill road, Wayville SA 5034
Country
Australia
Secondary sponsor category [1] 312804 0
None
Name [1] 312804 0
Address [1] 312804 0
Country [1] 312804 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310889 0
Bellberry Pty Ltd
Ethics committee address [1] 310889 0
123 Glen Osmond Rd, Eastwood SA 5063
Ethics committee country [1] 310889 0
Australia
Date submitted for ethics approval [1] 310889 0
18/03/2022
Approval date [1] 310889 0
10/05/2022
Ethics approval number [1] 310889 0
HREC2022-03-204

Summary
Brief summary
This is a prospective, single-encounter, observational online survey of male and female adults who have chronic low back pain. The main objective is to evaluate the different types of pain experienced using a validated pain questionnaire, and also, respondent satisfaction with different types of pain management experienced by participants who have low back pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119242 0
Dr Matthew Green
Address 119242 0
Cercare Pty Ltd
5 Greenhill road, Wayville, SA, 5034
Country 119242 0
Australia
Phone 119242 0
+61 410567855
Fax 119242 0
+61 8 83404488
Email 119242 0
[email protected]
Contact person for public queries
Name 119243 0
Helen Plummer
Address 119243 0
Cercare Pty Ltd
5 Greenhill road, Wayville, SA, 5034
Country 119243 0
Australia
Phone 119243 0
+61 410 567 855
Fax 119243 0
+61 8 8340 4488
Email 119243 0
[email protected]
Contact person for scientific queries
Name 119244 0
Matthew Green
Address 119244 0
Cercare Pty Ltd
5 Greenhill road, Wayville, SA, 5034
Country 119244 0
Australia
Phone 119244 0
+61 8 8340 7733
Fax 119244 0
+61 8 8340 4488
Email 119244 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
NO - IPD will not be available


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.