Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000351617
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
9/09/2005
Date last updated
9/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of a physiotherapy assessment of work capacity and return to work needs for people with chronic neck and back pain.
Scientific title
The effect of a physiotherapy assessment of work capacity and return to work needs for people with chronic neck and back pain.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain 445 0
Condition category
Condition code
Alternative and Complementary Medicine 521 521 0 0
Pain management
Physical Medicine / Rehabilitation 522 522 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed project addresses the major problem of chronic disability caused by occupational back pain and its escalating associated costs. This is a randomised, assessor blinded two-arm trial that tests the efficacy of the provision of evidence-based information regarding barriers to return to work and injury management recommendations to the treating doctor and insurer case managers, in reducing the number of sick days lost for workers with back pain when compared to usual care.
QBE insurance case managers recruit subjects at their usual weekly file review. Subjects are randomised into either experimental (KNP assessment) or control group (usual injury management care). The Key Needs Profile (KNP) is an assessment tool that provides injury management recommendations based on a systematic analysis of physical, psychosocial and workplace barriers to return to work for workers with chronic back pain.
Intervention code [1] 378 0
Rehabilitation
Comparator / control treatment
Control group (usual injury management care).
Control group
Active

Outcomes
Primary outcome [1] 590 0
The primary outcome is time to return to full duties. Workers will be considered to have returned to full duties if they are working full time/full duties and there is no insurer make-up pay.
Timepoint [1] 590 0
Secondary outcome [1] 1254 0
Number of days off work
Timepoint [1] 1254 0
All outcome data will be collected from the insurer’s database and worker’s files, based on entries and invoices from workers or service providers obtained 26 weeks after randomisation.
Secondary outcome [2] 1255 0
Number of days on suitable duties
Timepoint [2] 1255 0
All outcome data will be collected from the insurer’s database and worker’s files, based on entries and invoices from workers or service providers obtained 26 weeks after randomisation.
Secondary outcome [3] 1256 0
Total insurance claims costs
Timepoint [3] 1256 0
All outcome data will be collected from the insurer’s database and worker’s files, based on entries and invoices from workers or service providers obtained 26 weeks after randomisation.
Secondary outcome [4] 1257 0
Medical costs and physiotherapy costs.
Timepoint [4] 1257 0
All outcome data will be collected from the insurer’s database and worker’s files, based on entries and invoices from workers or service providers obtained 26 weeks after randomisation.

Eligibility
Key inclusion criteria
The inclusion criteria are that each worker have a new claim for a back injury of minimum 12 and maximum 26 weeks from date of first symptoms reported, be over 16 years of age with workers' compensation claim forms lodged by employer and worker, and a WorkCover medical certificate relating to the back injury certifying him/her unfit for work or fit for suitable duties.
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We exclude workers who are diagnosed with specific conditions such as tumours, tuberculosis, spinal fractures, ankylosing spondylitis or infection as the cause of their back pain, or who are pregnant at the time of referral.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A stratified randomisation method will be used to ensure that workers are as similar as possible across the study groups. Duration of back pain symptoms (less than or longer than 6 weeks) will be prestratified. Workers will be blindly and randomly allocated to a KNP (experimental) or management as usual (control) groups based on a computer-generated list of random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
209
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 580 0
Government body
Name [1] 580 0
ARC SESQUI R & D SCHEME - 2004
Country [1] 580 0
Australia
Primary sponsor type
Name
N/A
Address
Country
Secondary sponsor category [1] 470 0
None
Name [1] 470 0
N/A
Address [1] 470 0
Country [1] 470 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1602 0
The Universtiy of Sydney
Ethics committee address [1] 1602 0
Ethics committee country [1] 1602 0
Australia
Date submitted for ethics approval [1] 1602 0
Approval date [1] 1602 0
Ethics approval number [1] 1602 0

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

Contacts
Principal investigator
Name 35596 0
Address 35596 0
Country 35596 0
Phone 35596 0
Fax 35596 0
Email 35596 0
Contact person for public queries
Name 9567 0
Eva Schonstein
Address 9567 0
School of Physiotherapy
Faculty of Healthy Sciences
University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 9567 0
Australia
Phone 9567 0
+61 2 93519550
Fax 9567 0
+61 2 93519278
Email 9567 0
e.schonstein@fhs.usyd.edu.au
Contact person for scientific queries
Name 495 0
Eva Schonstein
Address 495 0
School of Physiotherapy
Faculty of Healthy Sciences
University of Sydney
Cumberland Campus
East St
Lidcombe NSW 2141
Country 495 0
Australia
Phone 495 0
+61 2 93519550
Fax 495 0
+61 2 93519278
Email 495 0
e.schonstein@fhs.usyd.edu.au

No information has been provided regarding IPD availability


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.